Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change from baseline to after intervention in Shoulder Flexion Strength |
A manual muscle test (MMT) will be conducted to measure shoulder flexion strength of the affected arm. |
Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
|
Primary |
Change from baseline to after intervention in Shoulder Abduction Strength |
A manual muscle test (MMT) will be conducted to measure shoulder abduction strength of the affected arm. |
Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
|
Primary |
Change from baseline to after intervention in Bicep Strength |
A manual muscle test (MMT) will be conducted to measure bicep strength of the affected arm. |
Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
|
Primary |
Change from baseline to after intervention in Triceps Strength |
A manual muscle test (MMT) will be conducted to measure triceps strength of the affected arm. |
Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
|
Primary |
Change from baseline to after intervention in Hand Grip Strength |
A manual muscle test (MMT) or dynamometer will be used to measure hand grip strength of the affected arm. |
Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
|
Primary |
Change from baseline to after intervention in Modified Ashworth Scale: Bicep |
Bicep muscle spasticity of the affected arm will be measured according to the Modified Ashworth Scale. |
Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
|
Primary |
Change from baseline to after intervention in Modified Ashworth Scale: Triceps |
Triceps muscle spasticity of the affected arm will be measured according to the Modified Ashworth Scale. |
Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
|
Primary |
Change from baseline to after intervention in Modified Ashworth Scale: Wrist Flexors |
Wrist flexors muscle spasticity of the affected arm will be measured according to the Modified Ashworth Scale. |
Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
|
Primary |
Change from baseline to after intervention in Modified Ashworth Scale: Wrist Extensors |
Wrist extensors muscle spasticity of the affected arm will be measured according to the Modified Ashworth Scale. |
Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
|
Primary |
Change from baseline to after intervention in Modified Ashworth Scale: Finger Flexors |
Finger flexors muscle spasticity of the affected arm will be measured according to the Modified Ashworth Scale. |
Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
|
Primary |
Change from baseline to after intervention in Modified Ashworth Scale: Finger Extensors |
Finger extensors muscle spasticity of the affected arm will be measured according to the Modified Ashworth Scale. |
Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
|
Primary |
Change from baseline to after intervention in Active Range of Motion: Shoulder Flexion |
Active shoulder flexion range of motion of the affected arm will be measured. |
Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
|
Primary |
Change from baseline to after intervention in Active Range of Motion: Shoulder Extension |
Active shoulder extension range of motion of the affected arm will be measured. |
Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
|
Primary |
Change from baseline to after intervention in Active Range of Motion: Shoulder Abduction |
Active shoulder abduction range of motion of the affected arm will be measured. |
Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
|
Primary |
Change from baseline to after intervention in Active Range of Motion: Shoulder Adduction |
Active shoulder adduction range of motion of the affected arm will be measured. |
Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
|
Primary |
Change from baseline to after intervention in Active Range of Motion: Elbow Flexion |
Active elbow flexion range of motion of the affected arm will be measured. |
Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
|
Primary |
Change from baseline to after intervention in Active Range of Motion: Elbow Extension |
Active elbow extension range of motion of the affected arm will be measured. |
Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
|
Primary |
Change from baseline to after intervention in Active Range of Motion: Wrist Flexion |
Active wrist flexion range of motion of the affected arm will be measured. |
Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
|
Primary |
Change from baseline to after intervention in Active Range of Motion: Wrist Extension |
Active wrist extension range of motion of the affected arm will be measured. |
Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
|
Primary |
Change from baseline to after intervention in Passive Range of Motion: Shoulder Flexion |
Passive shoulder flexion range of motion of the affected arm will be measured. |
Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
|
Primary |
Change from baseline to after intervention in Passive Range of Motion: Shoulder Extension |
Passive shoulder extension range of motion of the affected arm will be measured. |
Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
|
Primary |
Change from baseline to after intervention in Passive Range of Motion: Shoulder Abduction |
Passive shoulder abduction range of motion of the affected arm will be measured. |
Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
|
Primary |
Change from baseline to after intervention in Passive Range of Motion: Shoulder Adduction |
Passive shoulder adduction range of motion of the affected arm will be measured. |
Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
|
Primary |
Change from baseline to after intervention in Passive Range of Motion: Elbow Flexion |
Passive elbow flexion range of motion of the affected arm will be measured. |
Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
|
Primary |
Change from baseline to after intervention in Passive Range of Motion: Elbow Extension |
Passive elbow extension range of motion of the affected arm will be measured. |
Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
|
Primary |
Change from baseline to after intervention in Passive Range of Motion: Wrist Flexion |
Passive wrist flexion range of motion of the affected arm will be measured. |
Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
|
Primary |
Change from baseline to after intervention in Passive Range of Motion: Wrist Extension |
Passive wrist extension range of motion of the affected arm will be measured. |
Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
|
Primary |
Functional Timed Tasks Score |
Participants will complete a pre-identified battery of functional timed tasks that will be scored. |
Baseline, 2-weeks post fitting, monthly for 12-months post fitting |
|
Primary |
Functional Timed Tasks Time |
Participants will complete a pre-identified battery of functional timed tasks that will be timed. |
Baseline, 2-weeks post fitting, monthly for 12-months post fitting |
|
Secondary |
Elbow flex/extend |
The number of elbow flex/extend repetitions per day will be recorded. |
2-weeks post fitting, monthly for 12-months post fitting |
|
Secondary |
Hand open/close |
The number of hand open/close repetitions per day will be recorded. |
2-weeks post fitting, monthly for 12-months post fitting |
|
Secondary |
Quality of life rating |
Participants will be asked to rate their quality of life from "Very Poor" to "Very Good". |
Baseline, 2-weeks post fitting, monthly for 12-months post fitting |
|