Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change From Baseline in Fugl Meyer Upper Extremity Scale at Post Treatment |
Fugl Meyer Upper Extremity Scale (FMUE) is considered the gold standard in upper extremity rehabilitation trials and measures upper extremity motor control by asking the participant to perform various arm and hand motions. Items are scored on a 3-point ordinal scale with 0 representing inability to complete the item and 2 representing the ability to complete the item as asked. We will use the total score, which ranges from 0-66. Higher score suggest better upper extremity motor control. The FMUE has been shown to have good reliability and validity. |
Baseline, 6 weeks. |
|
Primary |
Change From Baseline in Fugl Meyer Upper Extremity Scale at 3 Months Post Treatment |
Fugl Meyer Upper Extremity Scale (FMUE) is considered the gold standard in upper extremity rehabilitation trials and measures upper extremity motor control by asking the participant to perform various arm and hand motions. Items are scored on a 3-point ordinal scale with 0 representing inability to complete the item and 2 representing the ability to complete the item as asked. We will use the total score, which ranges from 0-66. Higher score suggest better upper extremity motor control. The FMUE has been shown to have good reliability and validity. |
Baseline, 3 months. |
|
Secondary |
Change From Baseline in Wolf Motor Function Test at Post Treatment |
The Wolf Motor Function Test (WMFT) is a 15-item test in which participants are given 2 minutes to complete each item. The items increase in difficulty from simple UE movements requiring few degrees of freedom (e.g. placing hand on a table) to tasks requiring the coordination of many degrees of freedom of movement (e.g. folding a towel). We used average time taken to complete the 15-items. Faster performance is indicative of better task performance. The WMFT is a valid and reliable test of UE function post-stroke. |
Baseline, 6 weeks. |
|
Secondary |
Change From Baseline in Wolf Motor Function Test at 3 Months Post Treatment |
The Wolf Motor Function Test (WMFT) is a 15-item test in which participants are given 2 minutes to complete each item. The items increase in difficulty from simple UE movements requiring few degrees of freedom (e.g. placing hand on a table) to tasks requiring the coordination of many degrees of freedom of movement (e.g. folding a towel). We used average time taken to complete the 15-items. Faster performance is indicative of better task performance. The WMFT is a valid and reliable test of UE function post-stroke. |
Baseline, 3 months. |
|
Secondary |
Change From Baseline in Grip Strength at Post Treatment |
Grip strength measures the amount of maximum voluntary grip force of the weak hand using a hand-held dynamometer. We will use the maximum amount of force in pounds. |
Baseline, 6 weeks. |
|
Secondary |
Change From Baseline in Grip Strength at 3 Months Post Treatment |
Grip strength measures the amount of maximum voluntary grip force of the weak hand using a hand-held dynamometer. We will use the maximum amount of force in pounds. |
Baseline, 3 months. |
|
Secondary |
Change From Baseline in Hand Subscale of Stroke Impact Scale at Post Treatment |
The Hand sub scale of Stroke Impact Scale 3.0 (HSIS) will be used to measure the impact of stroke on participants' health and daily life. The Hand sub scale SIS is a self-report measure, which evaluates the ability of the hand to participate in daily tasks. The scale consists of 5 items and each item is scored on a 5-item Likert scale. We will use the total score, which ranges from 1-25, with a higher score indicative of better recovery. |
Baseline, 6 weeks. |
|
Secondary |
Change From Baseline in Hand Subscale of Stroke Impact Scale at 3 Months Post Treatment |
The Hand sub scale of Stroke Impact Scale 3.0 (HSIS) will be used to measure the impact of stroke on participants' health and daily life. The Hand sub scale SIS is a self-report measure, which evaluates the ability of the hand to participate in daily tasks. The scale consists of 5 items and each item is scored on a 5-item Likert scale. We will use the total score, which ranges from 1-25, with a higher score indicative of better recovery. |
Baseline, 3 months. |
|
Secondary |
Change From Baseline in Action Research Arm Test at Post Treatment |
Action Research Arm Test (ARAT) measures arm and hand recovery after stroke. The ARAT is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). The total score from the 4 sub-tests ranges from 0-57. We will use total score. Higher scores suggest better ability to grasp, grip and perform arm movements. |
Baseline, 6 weeks. |
|
Secondary |
Change From Baseline in Action Research Arm Test at 3 Months Post Treatment |
Action Research Arm Test (ARAT) measures arm and hand recovery after stroke. The ARAT is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). The total score from the 4 sub-tests ranges from 0-57. We will use total score. Higher scores suggest better ability to grasp, grip and perform arm movements. |
Baseline, 3 months. |
|
Secondary |
Change in Baseline in H-reflex at Post Treatment |
H-reflex testing will be used to record the spastic reflex in the Flexor carper radials (FCR) muscle of the weak hand. H-reflex is the reflex reaction of the muscles after electrical stimulation of the peripheral nerves supplying the muscle. Here we will stimulate the median nerve to stimulate and record the H-reflex values of the H-reflex. Normalized H-reflex values will be used. Lower values represent decrease in spasticity in the FCR after treatment. |
Baseline, 6 weeks. |
|
Secondary |
Change in Baseline in H-reflex at 3 Months Post Treatment |
H-reflex testing will be used to record the spastic reflex in the Flexor carper radials (FCR) muscle of the weak hand. H-reflex is the reflex reaction of the muscles after electrical stimulation of the peripheral nerves supplying the muscle. Here we will stimulate the median nerve to stimulate and record the H-reflex values of the H-reflex. Normalized H-reflex values will be used. Lower values represent decrease in spasticity in the FCR after treatment. |
Baseline, 3 weeks. |
|
Secondary |
Change in Baseline in Brain Activity at Post Treatment |
Electroencephalography (EEG) will be used to record brain activity. EEG will be recorded while the participant is attempting to perform movements of the weak hand, or while they are at rest. We will attach EEG sensors to the scalp to measure brain activity. We will compute power of the EEG signal in the alpha and beta bands. Higher values will represent increase in brain activity post treatment. |
Baseline, 6 weeks. |
|
Secondary |
Change in Baseline in Brain Activity at 3 Months Post Treatment |
Electroencephalography (EEG) will be used to record brain activity. EEG will be recorded while the participant is attempting to perform movements of the weak hand, or while they are at rest. We will attach EEG sensors to the scalp to measure brain activity. We will compute power of the EEG signal in the alpha and beta bands. Higher values will represent increase in brain activity post treatment. |
Baseline, 3 months. |
|
Secondary |
Change in Baseline in Muscle Activity at Post Treatment |
We will record muscle activity using Electromyography (EMG). We will collect EMG using 2 methods: basic EMG and High Definition EMG. In the basic EMG we will use (2 sensors) for the extensor carpi radials and flexor carp radials muscles and record muscle activity during wrist movements. In the High Definition EMG participants will wear a forearm sleeve, which will allows us to collect activity from multiple muscles, responsible for grasping and releasing objects of daily use. We will calculate the max voluntary contraction of the forearm muscles. Normalized values will be used. Higher values will represent increased muscle activity post treatment. |
Baseline, 6 weeks. |
|
Secondary |
Change in Baseline in Muscle Activity at 3 Months Post Treatment |
We will record muscle activity using Electromyography (EMG). We will collect EMG using 2 methods: basic EMG and High Definition EMG. In the basic EMG we will use (2 sensors) for the extensor carpi radials and flexor carp radials muscles and record muscle activity during wrist movements. In the High Definition EMG participants will wear a forearm sleeve, which will allows us to collect activity from multiple muscles, responsible for grasping and releasing objects of daily use. We will calculate the max voluntary contraction of the forearm muscles. Normalized values will be used. Higher values will represent increased muscle activity post treatment. |
Baseline, 3 months. |
|
Secondary |
Change in Baseline in Brain Excitability at Post Treatment |
We will use Transcranial Magnetic Stimulation (TMS) to measures the excitability of motor pathways in the brain. Normalized values will used. Higher values represent higher brain excitability post treatment. |
Baseline, 6 weeks. |
|
Secondary |
Change in Baseline in Brain Excitability at 3 Months Post Treatment |
We will use Transcranial Magnetic Stimulation (TMS) to measures the excitability of motor pathways in the brain. Normalized values will used. Higher values represent higher brain excitability post treatment. |
Baseline, 3 months. |
|
Secondary |
Change in in Baseline in Upper Extremity Kinematics at Post Treatment |
We will use motion capture system to measure changes in upper extremity kinematics, including shoulder, elbow, wrist joint range of motion. The values will be measured in degrees. Higher values will represent greater range of motion post treatment. |
Baseline, 6 weeks. |
|
Secondary |
Change in in Baseline in Upper Extremity Kinematics at 3 Months Post Treatment |
We will use motion capture system to measure changes in upper extremity kinematics, including shoulder, elbow, wrist joint range of motion. The values will be measured in degrees. Higher values will represent greater range of motion post treatment. |
Baseline, 3 months. |
|