Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
The Expanded Disability Status Scale (EDSS) |
The EDSS is a method of quantifying disability in MS and monitoring changes in the level of disability over time. EDSS steps 1.0 to 4.5 refer to people with MS who are able to walk without any aid and is based on measures of impairment in eight functional systems (FS): (1) pyramidal - muscle weakness or difficulty moving limbs;(subscale 0-6); (2) cerebellar - ataxia, loss of balance, coordination or tremor (subscale 0-5); (3) brainstem - problems with speech, swallowing, and nystagmus (subscale 0-5); (4) sensory - numbness or loss of sensations (subscale 0-6); (5) bowel and bladder function subscale (0-5); (6) visual function - problems with sight (subscale 0-6); (7) cerebral functions - problems with thinking and memory (subscale 0-5); (8) other (subscale 0-1). A functional system (FS) represents a network of neurons in the brain with responsibility for particular tasks. The total scale from 1 - 10, with higher score indicting more severe disability. |
Week 0 to 4 |
|
| Primary |
The Expanded Disability Status Scale (EDSS) |
The EDSS is a method of quantifying disability in MS and monitoring changes in the level of disability over time. EDSS steps 1.0 to 4.5 refer to people with MS who are able to walk without any aid and is based on measures of impairment in eight functional systems (FS): (1) pyramidal - muscle weakness or difficulty moving limbs;(subscale 0-6); (2) cerebellar - ataxia, loss of balance, coordination or tremor (subscale 0-5); (3) brainstem - problems with speech, swallowing, and nystagmus (subscale 0-5); (4) sensory - numbness or loss of sensations (subscale 0-6); (5) bowel and bladder function subscale (0-5); (6) visual function - problems with sight (subscale 0-6); (7) cerebral functions - problems with thinking and memory (subscale 0-5); (8) other (subscale 0-1). A functional system (FS) represents a network of neurons in the brain with responsibility for particular tasks. The total scale from 1 - 10, with higher score indicting more severe disability. |
Week 1-6 |
|
| Primary |
The Expanded Disability Status Scale (EDSS) |
The EDSS is a method of quantifying disability in MS and monitoring changes in the level of disability over time. EDSS steps 1.0 to 4.5 refer to people with MS who are able to walk without any aid and is based on measures of impairment in eight functional systems (FS): (1) pyramidal - muscle weakness or difficulty moving limbs;(subscale 0-6); (2) cerebellar - ataxia, loss of balance, coordination or tremor (subscale 0-5); (3) brainstem - problems with speech, swallowing, and nystagmus (subscale 0-5); (4) sensory - numbness or loss of sensations (subscale 0-6); (5) bowel and bladder function subscale (0-5); (6) visual function - problems with sight (subscale 0-6); (7) cerebral functions - problems with thinking and memory (subscale 0-5); (8) other (subscale 0-1). A functional system (FS) represents a network of neurons in the brain with responsibility for particular tasks. The total scale from 1 - 10, with higher score indicting more severe disability. |
Week 12-18 |
|
| Primary |
The Expanded Disability Status Scale (EDSS) |
The EDSS is a method of quantifying disability in MS and monitoring changes in the level of disability over time. EDSS steps 1.0 to 4.5 refer to people with MS who are able to walk without any aid and is based on measures of impairment in eight functional systems (FS): (1) pyramidal - muscle weakness or difficulty moving limbs;(subscale 0-6); (2) cerebellar - ataxia, loss of balance, coordination or tremor (subscale 0-5); (3) brainstem - problems with speech, swallowing, and nystagmus (subscale 0-5); (4) sensory - numbness or loss of sensations (subscale 0-6); (5) bowel and bladder function subscale (0-5); (6) visual function - problems with sight (subscale 0-6); (7) cerebral functions - problems with thinking and memory (subscale 0-5); (8) other (subscale 0-1). A functional system (FS) represents a network of neurons in the brain with responsibility for particular tasks. The total scale from 1 - 10, with higher score indicting more severe disability. |
Week 24-32 |
|
| Secondary |
Application Based - Timed Up and Go (TUG) |
A validated assessment of functional mobility. The participant is seated in a regular chair with no chair arm-rests. The participant will hold their mobile device in their hand, select the task on the application, and will perform the task without external cue. At the start of the test subjects will stand and walk to a mark three meters from where their feet are placed when sitting, turn 180 degrees, walk back to the chair, and sit to finish. The test result is recorded as the time from start to finish, with a shorter time indicating a lower level of impairment. |
Week 0 to 4 |
|
| Secondary |
Application Based - Timed Up and Go (TUG) |
A validated assessment of functional mobility. The participant is seated in a regular chair with no chair arm-rests. The participant will hold their mobile device in their hand, select the task on the application, and will perform the task without external cue. At the start of the test subjects will stand and walk to a mark three meters from where their feet are placed when sitting, turn 180 degrees, walk back to the chair, and sit to finish. The test result is recorded as the time from start to finish, with a shorter time indicating a lower level of impairment. |
Week 1-6 |
|
| Secondary |
Application Based - Timed Up and Go (TUG) |
A validated assessment of functional mobility. The participant is seated in a regular chair with no chair arm-rests. The participant will hold their mobile device in their hand, select the task on the application, and will perform the task without external cue. At the start of the test subjects will stand and walk to a mark three meters from where their feet are placed when sitting, turn 180 degrees, walk back to the chair, and sit to finish. The test result is recorded as the time from start to finish, with a shorter time indicating a lower level of impairment. |
Week 12-18 |
|
| Secondary |
Application Based - Timed Up and Go (TUG) |
A validated assessment of functional mobility. The participant is seated in a regular chair with no chair arm-rests. The participant will hold their mobile device in their hand, select the task on the application, and will perform the task without external cue. At the start of the test subjects will stand and walk to a mark three meters from where their feet are placed when sitting, turn 180 degrees, walk back to the chair, and sit to finish. The test result is recorded as the time from start to finish, with a shorter time indicating a lower level of impairment. |
Week 24-32 |
|
| Secondary |
Application Based - Tap Task |
Participants will be presented with a game on their mobile phone that requires them to tap a designated spot as frequently as possible for 10 seconds. The phone will record the number of taps, the regularity of their spacing, and any consistent change over time (fatigue). The test will be repeated 3 times. These measures will be used to make a determination on level of impairment. Higher quantity of taps, more regular spacing, and limited change over time is indicative of a lower level of impairment. |
Week 0 to 4 |
|
| Secondary |
Application Based - Tap Task |
Participants will be presented with a game on their mobile phone that requires them to tap a designated spot as frequently as possible for 10 seconds. The phone will record the number of taps, the regularity of their spacing, and any consistent change over time (fatigue). The test will be repeated 3 times. These measures will be used to make a determination on level of impairment. Higher quantity of taps, more regular spacing, and limited change over time is indicative of a lower level of impairment. |
Week 1-6 |
|
| Secondary |
Application Based - Tap Task |
Participants will be presented with a game on their mobile phone that requires them to tap a designated spot as frequently as possible for 10 seconds. The phone will record the number of taps, the regularity of their spacing, and any consistent change over time (fatigue). The test will be repeated 3 times. These measures will be used to make a determination on level of impairment. Higher quantity of taps, more regular spacing, and limited change over time is indicative of a lower level of impairment. |
Week 12-18 |
|
| Secondary |
Application Based - Tap Task |
Participants will be presented with a game on their mobile phone that requires them to tap a designated spot as frequently as possible for 10 seconds. The phone will record the number of taps, the regularity of their spacing, and any consistent change over time (fatigue). The test will be repeated 3 times. These measures will be used to make a determination on level of impairment. Higher quantity of taps, more regular spacing, and limited change over time is indicative of a lower level of impairment. |
Week 24-32 |
|
| Secondary |
Application Based - Path Test |
This task asks participants to move an object in the application with their index finger on such that it stays within the boundaries of a moving path. The App will measure deviations outside the path as well as circumstances in which these deviations occur. The test will be repeated 3 times on each side. A lower number of deviations is indicative of a lower level of impairment. |
Week 0 to 4 |
|
| Secondary |
Application Based - Path Test |
This task asks participants to move an object in the application with their index finger on such that it stays within the boundaries of a moving path. The App will measure deviations outside the path as well as circumstances in which these deviations occur. The test will be repeated 3 times on each side. A lower number of deviations is indicative of a lower level of impairment. |
Week 1-6 |
|
| Secondary |
Application Based - Path Test |
This task asks participants to move an object in the application with their index finger on such that it stays within the boundaries of a moving path. The App will measure deviations outside the path as well as circumstances in which these deviations occur. The test will be repeated 3 times on each side. A lower number of deviations is indicative of a lower level of impairment. |
Week 12-18 |
|
| Secondary |
Application Based - Path Test |
This task asks participants to move an object in the application with their index finger on such that it stays within the boundaries of a moving path. The App will measure deviations outside the path as well as circumstances in which these deviations occur. The test will be repeated 3 times on each side. A lower number of deviations is indicative of a lower level of impairment. |
Week 24-32 |
|
| Secondary |
Application Based - Transcription test |
In this test the subject is given a short auditory phrase and then must type that phrase using a virtual keyboard. The time to complete typing the phrase as well as the time-interval and time-variance between keystrokes is compiled. To control for fine motor function, the virtual keyboard records the time and variance for tapping a series of keys that spontaneously change color (white background to green for example), which is termed the maximal keystroke velocity (strokes/second). A higher maximal keystroke velocity, a lower time-interval, and lower time-variance are associated with a lower level of impairment. |
Week 0 to 4 |
|
| Secondary |
Application Based - Transcription test |
In this test the subject is given a short auditory phrase and then must type that phrase using a virtual keyboard. The time to complete typing the phrase as well as the time-interval and time-variance between keystrokes is compiled. To control for fine motor function, the virtual keyboard records the time and variance for tapping a series of keys that spontaneously change color (white background to green for example), which is termed the maximal keystroke velocity (strokes/second). A higher maximal keystroke velocity, a lower time-interval, and lower time-variance are associated with a lower level of impairment. |
Week 1-6 |
|
| Secondary |
Application Based - Transcription test |
In this test the subject is given a short auditory phrase and then must type that phrase using a virtual keyboard. The time to complete typing the phrase as well as the time-interval and time-variance between keystrokes is compiled. To control for fine motor function, the virtual keyboard records the time and variance for tapping a series of keys that spontaneously change color (white background to green for example), which is termed the maximal keystroke velocity (strokes/second). A higher maximal keystroke velocity, a lower time-interval, and lower time-variance are associated with a lower level of impairment. |
Week 12-18 |
|
| Secondary |
Application Based - Transcription test |
In this test the subject is given a short auditory phrase and then must type that phrase using a virtual keyboard. The time to complete typing the phrase as well as the time-interval and time-variance between keystrokes is compiled. To control for fine motor function, the virtual keyboard records the time and variance for tapping a series of keys that spontaneously change color (white background to green for example), which is termed the maximal keystroke velocity (strokes/second). A higher maximal keystroke velocity, a lower time-interval, and lower time-variance are associated with a lower level of impairment. |
Week 24-32 |
|
| Secondary |
Application Based - Timed 25-foot walk |
At the start of the test, the subject is standing at a mark (typically taped on the floor) and is prepared to walk to the destination mark 25 feet away. The participant holds their phone in their hand, selects the test, and then performs the test without a cue. The Subject then walks as quickly as possible while remaining safe, to the 25-foot mark. The test result is recorded as the time from start to finish. A faster time is indicative of a lower level of impairment. |
Week 0 to 4 |
|
| Secondary |
Application Based - Timed 25-foot walk |
At the start of the test, the subject is standing at a mark (typically taped on the floor) and is prepared to walk to the destination mark 25 feet away. The participant holds their phone in their hand, selects the test, and then performs the test without a cue. The Subject then walks as quickly as possible while remaining safe, to the 25-foot mark. The test result is recorded as the time from start to finish. A faster time is indicative of a lower level of impairment. |
Week 1-6 |
|
| Secondary |
Application Based - Timed 25-foot walk |
At the start of the test, the subject is standing at a mark (typically taped on the floor) and is prepared to walk to the destination mark 25 feet away. The participant holds their phone in their hand, selects the test, and then performs the test without a cue. The Subject then walks as quickly as possible while remaining safe, to the 25-foot mark. The test result is recorded as the time from start to finish. A faster time is indicative of a lower level of impairment. |
Week 12-18 |
|
| Secondary |
Application Based - Timed 25-foot walk |
At the start of the test, the subject is standing at a mark (typically taped on the floor) and is prepared to walk to the destination mark 25 feet away. The participant holds their phone in their hand, selects the test, and then performs the test without a cue. The Subject then walks as quickly as possible while remaining safe, to the 25-foot mark. The test result is recorded as the time from start to finish. A faster time is indicative of a lower level of impairment. |
Week 24-32 |
|
| Secondary |
Application Based - Coded Message Cognitive Test |
Participants are presented with a key where symbols are mapped to a letter or word. The participant is then presented with a list of symbols and asked to convert them to the letter or word. This is a timed test. A faster time is indicative of a lower level of impairment. |
Week 0 to 4 |
|
| Secondary |
Application Based - Coded Message Cognitive Test |
Participants are presented with a key where symbols are mapped to a letter or word. The participant is then presented with a list of symbols and asked to convert them to the letter or word. This is a timed test. A faster time is indicative of a lower level of impairment. |
Week 1-6 |
|
| Secondary |
Application Based - Coded Message Cognitive Test |
Participants are presented with a key where symbols are mapped to a letter or word. The participant is then presented with a list of symbols and asked to convert them to the letter or word. This is a timed test. A faster time is indicative of a lower level of impairment. |
Week 12-18 |
|
| Secondary |
Application Based - Coded Message Cognitive Test |
Participants are presented with a key where symbols are mapped to a letter or word. The participant is then presented with a list of symbols and asked to convert them to the letter or word. This is a timed test. A faster time is indicative of a lower level of impairment. |
Week 24-32 |
|
| Secondary |
Application Based - Six-minute walk test |
Participants are asked to walk at a comfortable pace for 6 minutes while the BeCare application records distance using GPS and records the number of steps taken using the mobile devices accelerometer. A higher distance traveled and number of steps taken is indicative of a lower level of impairment. |
Week 0 to 4 |
|
| Secondary |
Application Based - Six-minute walk test |
Participants are asked to walk at a comfortable pace for 6 minutes while the BeCare application records distance using GPS and records the number of steps taken using the mobile devices accelerometer. A higher distance traveled and number of steps taken is indicative of a lower level of impairment. |
Week 1-6 |
|
| Secondary |
Application Based - Six-minute walk test |
Participants are asked to walk at a comfortable pace for 6 minutes while the BeCare application records distance using GPS and records the number of steps taken using the mobile devices accelerometer. A higher distance traveled and number of steps taken is indicative of a lower level of impairment. |
Week 12-18 |
|
| Secondary |
Application Based - Six-minute walk test |
Participants are askedParticipants are asked to walk at a comfortable pace for 6 minutes while the BeCare application records distance using GPS and records the number of steps taken using the mobile devices accelerometer. A higher distance traveled and number of steps taken is indicative of a lower level of impairment. to walk at a comfortable pace for 6 minutes while the BeCare application records distance using GPS and records the number of steps taken using the mobile devices accelerometer. |
Week 24-32 |
|
| Secondary |
Application Based - Contrast sensitivity test |
For this test the subject is asked to discern or read letters/numerals off a screen with varying contrast sensitivity (grey on grey). Next to each letter/number is a box for them to enter the character/numeral using a virtual keyboard. The number of correct assignments is recorded and reported as a fraction of the total number tested. A greater number of correct assignments is indicative of a lower level of impairment. |
Week 0 to 4 |
|
| Secondary |
Application Based - Contrast sensitivity test |
For this test the subject is asked to discern or read letters/numerals off a screen with varying contrast sensitivity (grey on grey). Next to each letter/number is a box for them to enter the character/numeral using a virtual keyboard. The number of correct assignments is recorded and reported as a fraction of the total number tested. A greater number of correct assignments is indicative of a lower level of impairment. |
Week 1-6 |
|
| Secondary |
Application Based - Contrast sensitivity test |
For this test the subject is asked to discern or read letters/numerals off a screen with varying contrast sensitivity (grey on grey). Next to each letter/number is a box for them to enter the character/numeral using a virtual keyboard. The number of correct assignments is recorded and reported as a fraction of the total number tested. A greater number of correct assignments is indicative of a lower level of impairment. |
Week 12-18 |
|
| Secondary |
Application Based - Contrast sensitivity test |
For this test the subject is asked to discern or read letters/numerals off a screen with varying contrast sensitivity (grey on grey). Next to each letter/number is a box for them to enter the character/numeral using a virtual keyboard. The number of correct assignments is recorded and reported as a fraction of the total number tested. A greater number of correct assignments is indicative of a lower level of impairment. |
Week 24-32 |
|
| Secondary |
Application Based - Arm elevation test |
Participants are asked to hold their mobile device in their dominant hand and then raise their arms to pass the devise to their other hand over the top of their head. This is repeated as fast as possible for 30 seconds. Number of successful passes is measured. A higher number of passes is indicative of lower level of impairment. |
Week 0 to 4 |
|
| Secondary |
Application Based - Arm elevation test |
Participants are asked to hold their mobile device in their dominant hand and then raise their arms to pass the devise to their other hand over the top of their head. This is repeated as fast as possible for 30 seconds. Number of successful passes is measured. A higher number of passes is indicative of lower level of impairment. |
Week 1-6 |
|
| Secondary |
Application Based - Arm elevation test |
Participants are asked to hold their mobile device in their dominant hand and then raise their arms to pass the devise to their other hand over the top of their head. This is repeated as fast as possible for 30 seconds. Number of successful passes is measured. A higher number of passes is indicative of lower level of impairment. |
Week 12-18 |
|
| Secondary |
Application Based - Arm elevation test |
Participants are asked to hold their mobile device in their dominant hand and then raise their arms to pass the devise to their other hand over the top of their head. This is repeated as fast as possible for 30 seconds. Number of successful passes is measured. A higher number of passes is indicative of lower level of impairment. |
Week 24-32 |
|
| Secondary |
Application Based - Memory test |
For this test the subject is presented with 5 animals in 5 colors that appear in boxes in 2 rows, 2 of the boxes with animals are randomly selected and, after 8 seconds, one of the 2 choices are closed. The subject must remember first the animal and color in the box that was closed from the choices that appear, and, on the next round, the subject must remember the previous animal and color from the box that was not presented on the previous round. The choice as to the box that is closed will be mathematically determined to pose the same risk/difficulty for each subject. The number of errors is recorded and the number of correct choices is recorded over 90 seconds. A lower number of errors is indicative of a lower level of impairment. |
Week 0 to 4 |
|
| Secondary |
Application Based - Memory test |
For this test the subject is presented with 5 animals in 5 colors that appear in boxes in 2 rows, 2 of the boxes with animals are randomly selected and, after 8 seconds, one of the 2 choices are closed. The subject must remember first the animal and color in the box that was closed from the choices that appear, and, on the next round, the subject must remember the previous animal and color from the box that was not presented on the previous round. The choice as to the box that is closed will be mathematically determined to pose the same risk/difficulty for each subject. The number of errors is recorded and the number of correct choices is recorded over 90 seconds. A lower number of errors is indicative of a lower level of impairment. |
Week 1-6 |
|
| Secondary |
Application Based - Memory test |
For this test the subject is presented with 5 animals in 5 colors that appear in boxes in 2 rows, 2 of the boxes with animals are randomly selected and, after 8 seconds, one of the 2 choices are closed. The subject must remember first the animal and color in the box that was closed from the choices that appear, and, on the next round, the subject must remember the previous animal and color from the box that was not presented on the previous round. The choice as to the box that is closed will be mathematically determined to pose the same risk/difficulty for each subject. The number of errors is recorded and the number of correct choices is recorded over 90 seconds. A lower number of errors is indicative of a lower level of impairment. |
Week 12-18 |
|
| Secondary |
Application Based - Memory test |
For this test the subject is presented with 5 animals in 5 colors that appear in boxes in 2 rows, 2 of the boxes with animals are randomly selected and, after 8 seconds, one of the 2 choices are closed. The subject must remember first the animal and color in the box that was closed from the choices that appear, and, on the next round, the subject must remember the previous animal and color from the box that was not presented on the previous round. The choice as to the box that is closed will be mathematically determined to pose the same risk/difficulty for each subject. The number of errors is recorded and the number of correct choices is recorded over 90 seconds. A lower number of errors is indicative of a lower level of impairment. |
Week 24-32 |
|
| Secondary |
Application Based - Vibration test |
Participants will be asked to first hold the phone in your right hand and then left hand. The phone will vibrate. The vibration frequency will change several times during the test. Participants will be instructed to hit a box every time to sense a vibration change. Response accuracy will be calculated. A higher level of accuracy is indicative of a lower level of impairment. |
Week 0 to 4 |
|
| Secondary |
Application Based - Vibration test |
Participants will be asked to first hold the phone in your right hand and then left hand. The phone will vibrate. The vibration frequency will change several times during the test. Participants will be instructed to hit a box every time to sense a vibration change. Response accuracy will be calculated. A higher level of accuracy is indicative of a lower level of impairment. |
Week 1-6 |
|
| Secondary |
Application Based - Vibration test |
Participants will be asked to first hold the phone in your right hand and then left hand. The phone will vibrate. The vibration frequency will change several times during the test. Participants will be instructed to hit a box every time to sense a vibration change. Response accuracy will be calculated. A higher level of accuracy is indicative of a lower level of impairment. |
Week 12-18 |
|
| Secondary |
Application Based - Vibration test |
Participants will be asked to first hold the phone in your right hand and then left hand. The phone will vibrate. The vibration frequency will change several times during the test. Participants will be instructed to hit a box every time to sense a vibration change. Response accuracy will be calculated. A higher level of accuracy is indicative of a lower level of impairment. |
Week 24-32 |
|
| Secondary |
Application Based - The Stroop Color and Word Test (SCWT) |
This is a neuropsychological test used to assess the ability to inhibit cognitive interference during simultaneous stimulus processing. Participants will see words written in different colors and will be asked to name the text color. Higher accuracy in naming the text color is indicative of a lower level of impairment. |
Week 0 to 4 |
|
| Secondary |
Application Based - The Stroop Color and Word Test (SCWT) |
This is a neuropsychological test used to assess the ability to inhibit cognitive interference during simultaneous stimulus processing. Participants will see words written in different colors and will be asked to name the text color. Higher accuracy in naming the text color is indicative of a lower level of impairment. |
Week 1-6 |
|
| Secondary |
Application Based - The Stroop Color and Word Test (SCWT) |
This is a neuropsychological test used to assess the ability to inhibit cognitive interference during simultaneous stimulus processing. Participants will see words written in different colors and will be asked to name the text color. Higher accuracy in naming the text color is indicative of a lower level of impairment. |
Week 12-18 |
|
| Secondary |
Application Based - The Stroop Color and Word Test (SCWT) |
This is a neuropsychological test used to assess the ability to inhibit cognitive interference during simultaneous stimulus processing. Participants will see words written in different colors and will be asked to name the text color. Higher accuracy in naming the text color is indicative of a lower level of impairment. |
Week 24-32 |
|
| Secondary |
Application Based - Self-reported mood, quality of life, function, and participation. |
Questions include: Mood assessment (Angry/Happy/Sad/Frustrated/Tired/Scared); dietary restrictions; employment (Working/Unemployed/Disabled/Cared for a home/student/ retired/ other), frequency of physical exercise (hours/week), presence and severity of cognitive symptoms (concentration, memory, executive function); number of missed work or social events because of MS, presence/absence of other symptoms or events (blurred vision, double vision, altered vision, falls, urinary incontinence). |
Week 0-4 |
|
| Secondary |
Application Based - Self-reported mood, quality of life, function, and participation. |
Questions include: Mood assessment (Angry/Happy/Sad/Frustrated/Tired/Scared); dietary restrictions; employment (Working/Unemployed/Disabled/Cared for a home/student/ retired/ other), frequency of physical exercise (hours/week), presence and severity of cognitive symptoms (concentration, memory, executive function); number of missed work or social events because of MS, presence/absence of other symptoms or events (blurred vision, double vision, altered vision, falls, urinary incontinence). |
Week 1-6 |
|
| Secondary |
Application Based - Self-reported mood, quality of life, function, and participation. |
Questions include: Mood assessment (Angry/Happy/Sad/Frustrated/Tired/Scared); dietary restrictions; employment (Working/Unemployed/Disabled/Cared for a home/student/ retired/ other), frequency of physical exercise (hours/week), presence and severity of cognitive symptoms (concentration, memory, executive function); number of missed work or social events because of MS, presence/absence of other symptoms or events (blurred vision, double vision, altered vision, falls, urinary incontinence). |
Week 12-18 |
|
| Secondary |
Application Based - Self-reported mood, quality of life, function, and participation. |
Questions include: Mood assessment (Angry/Happy/Sad/Frustrated/Tired/Scared); dietary restrictions; employment (Working/Unemployed/Disabled/Cared for a home/student/ retired/ other), frequency of physical exercise (hours/week), presence and severity of cognitive symptoms (concentration, memory, executive function); number of missed work or social events because of MS, presence/absence of other symptoms or events (blurred vision, double vision, altered vision, falls, urinary incontinence). |
Week 24-32 |
|
| Secondary |
Clinician Based - The Nine-Hole Peg Test (9HPT) |
The 9HPT is used to measure finger dexterity in patients with various neurological diagnoses. Patients are asked to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible. They must then remove the pegs from the holes, one by one, and replace them back into the container. Scores are based on the time taken to complete the test activity, recorded in seconds. |
Week 0 to 4 |
|
| Secondary |
Clinician Based - The Nine-Hole Peg Test (9HPT) |
The 9HPT is used to measure finger dexterity in patients with various neurological diagnoses. Patients are asked to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible. They must then remove the pegs from the holes, one by one, and replace them back into the container. Scores are based on the time taken to complete the test activity, recorded in seconds. |
Week 1-6 |
|
| Secondary |
Clinician Based - The Nine-Hole Peg Test (9HPT) |
The 9HPT is used to measure finger dexterity in patients with various neurological diagnoses. Patients are asked to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible. They must then remove the pegs from the holes, one by one, and replace them back into the container. Scores are based on the time taken to complete the test activity, recorded in seconds. |
Week 12-18 |
|
| Secondary |
Clinician Based - The Nine-Hole Peg Test (9HPT) |
The 9HPT is used to measure finger dexterity in patients with various neurological diagnoses. Patients are asked to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible. They must then remove the pegs from the holes, one by one, and replace them back into the container. Scores are based on the time taken to complete the test activity, recorded in seconds. |
Week 24-32 |
|
| Secondary |
Clinician Based - Red Saturation test |
Red saturation test assesses the integrity of the optic nerve by testing the ocular sensitivity to the red colour. The test is used clinically for the detection of asymmetric optic nerve function and detection of neurophthalmological visual field defects such as hemianopias and quadrantopias. |
Week 0 to 4 |
|
| Secondary |
Clinician Based - Red Saturation test |
Red saturation test assesses the integrity of the optic nerve by testing the ocular sensitivity to the red colour. The test is used clinically for the detection of asymmetric optic nerve function and detection of neurophthalmological visual field defects such as hemianopias and quadrantopias. |
Week 1-6 |
|
| Secondary |
Clinician Based - Red Saturation test |
Red saturation test assesses the integrity of the optic nerve by testing the ocular sensitivity to the red colour. The test is used clinically for the detection of asymmetric optic nerve function and detection of neurophthalmological visual field defects such as hemianopias and quadrantopias. |
Week 12-18 |
|
| Secondary |
Clinician Based - Red Saturation test |
Red saturation test assesses the integrity of the optic nerve by testing the ocular sensitivity to the red colour. The test is used clinically for the detection of asymmetric optic nerve function and detection of neurophthalmological visual field defects such as hemianopias and quadrantopias. |
Week 24-32 |
|
| Secondary |
Clinician Global Impression of Change (CGIC) |
CGIC assess clinician's impression of change on a scale ranging from Much better (1) to Much worse (7). |
Week 0 to 4 |
|
| Secondary |
Clinician Global Impression of Change (CGIC) |
CGIC assess clinician's impression of change on a scale ranging from Much better (1) to Much worse (7). |
Week 1-6 |
|
| Secondary |
Clinician Global Impression of Change (CGIC) |
CGIC assess clinician's impression of change on a scale ranging from Much better (1) to Much worse (7). |
Week 12-18 |
|
| Secondary |
Clinician Global Impression of Change (CGIC) |
CGIC assess clinician's impression of change on a scale ranging from Much better (1) to Much worse (7). |
Week 24-32 |
|
| Secondary |
Patient Global Impression of Change (PGIC ) |
PGIC assess participant's impression of change on a scale ranging from Much better (1) to Much worse (7). |
Week 0 to 4 |
|
| Secondary |
Patient Global Impression of Change (PGIC ) |
PGIC assess participant's impression of change on a scale ranging from Much better (1) to Much worse (7). |
Week 1-6 |
|
| Secondary |
Patient Global Impression of Change (PGIC ) |
PGIC assess participant's impression of change on a scale ranging from Much better (1) to Much worse (7). |
Week 12-18 |
|
| Secondary |
Patient Global Impression of Change (PGIC ) |
PGIC assess participant's impression of change on a scale ranging from Much better (1) to Much worse (7). |
Week 24-32 |
|
| Secondary |
Patient-reported - Multiple Sclerosis - Quality of Life (MS-QOL) |
Multidimensional health-related quality of life measure that combines both generic and MS-specific items. It includes 54 questions generating 12 subscales along with two summary scores, and two additional single-item measures. The 4 subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health, distress, overall quality of life, and sexual function. Each domain score is converted into a 0-100 score based on the individual item responses, with higher scores indicating better health status or functioning. |
Week 0 to 4 |
|
| Secondary |
Patient-reported - Multiple Sclerosis - Quality of Life (MS-QOL) |
Multidimensional health-related quality of life measure that combines both generic and MS-specific items. It includes 54 questions generating 12 subscales along with two summary scores, and two additional single-item measures. The 4 subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health, distress, overall quality of life, and sexual function. Each domain score is converted into a 0-100 score based on the individual item responses, with higher scores indicating better health status or functioning. |
Week 1-6 |
|
| Secondary |
Patient-reported - Multiple Sclerosis - Quality of Life (MS-QOL) |
Multidimensional health-related quality of life measure that combines both generic and MS-specific items. It includes 54 questions generating 12 subscales along with two summary scores, and two additional single-item measures. The 4 subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health, distress, overall quality of life, and sexual function. Each domain score is converted into a 0-100 score based on the individual item responses, with higher scores indicating better health status or functioning. |
Week 12-18 |
|
| Secondary |
Patient-reported - Multiple Sclerosis - Quality of Life (MS-QOL) |
Multidimensional health-related quality of life measure that combines both generic and MS-specific items. It includes 54 questions generating 12 subscales along with two summary scores, and two additional single-item measures. The 4 subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health, distress, overall quality of life, and sexual function. Each domain score is converted into a 0-100 score based on the individual item responses, with higher scores indicating better health status or functioning. |
Week 24-32 |
|
| Secondary |
Patient Health Questionnaire 9-item (PHQ-9) |
Patient reported instrument that includes questions designed to screen for the presence and severity of major depressive disorder. Full scale from 0-27, with higher score indicating more severe symptoms. |
Week 0 to 4 |
|
| Secondary |
Patient Health Questionnaire 9-item (PHQ-9) |
Patient reported instrument that includes questions designed to screen for the presence and severity of major depressive disorder. Full scale from 0-27, with higher score indicating more severe symptoms. |
Week 1-6 |
|
| Secondary |
Patient Health Questionnaire 9-item (PHQ-9) |
Patient reported instrument that includes questions designed to screen for the presence and severity of major depressive disorder. Full scale from 0-27, with higher score indicating more severe symptoms. |
Week 12-18 |
|
| Secondary |
Patient Health Questionnaire 9-item (PHQ-9) |
Patient reported instrument that includes questions designed to screen for the presence and severity of major depressive disorder. Full scale from 0-27, with higher score indicating more severe symptoms. |
Week 24-32 |
|
