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The goal of this study is to:
The goal of this study is to explore if the SynPhNe system can be used easily at home for people who suffered a stroke. With this study, we are also investigating if the SynPhNe system used could improve your hand function in comparison to conventional therapy.
SynPhNe is a non-invasive device. It consists of a piece worn around the forearm, a head component and it communicates wirelessly via Bluetooth with the computer to provide subject with feedback while performing motor tasks with their hand. The head cap records your brain activity and gives feedback to help relaxing while exercising.
The SynPhNe system has not been approved by the U.S. Food and Drug Administration.
Study participants will be randomized by chance (like a coin toss) to one of the two groups: lab-based upper extremity research therapy or the SynPhNe system for home-based exercises.
The study lasts for up to 12 weeks and involves up to 22 sessions in total:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SynPhNe therapy | Experimental | Subjects will be asked to participate in a program of 18 upper-extremity rehabilitation sessions of 60 minutes with SynPhNe platform, over 6 weeks. The sessions will emphasize wrist and fingers movements, including functional activities. During week the two first weeks, 6 sessions will be done under therapist supervision at the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital. Over the next 4 to 5 weeks, 10 sessions following exercises prompted by the SynPhNe system will be done unsupervised at home (or under limited supervision at the hospital), 2 sessions will be done at Spaulding Rehabilitation Hospital to review exercises with the SynPhNe system. Over the course of the study, participants will wear Axivity sensors to gather information about upper-extremity usage. |
|
| Conventional therapy | Active Comparator | Subjects will be asked to participate in a program of 18 upper-extremity rehabilitation sessions of 60 minutes under therapist supervision over two weeks at the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital. The sessions will emphasize wrist and fingers movements, including functional activities. During week the two first weeks, 6 sessions will be done under therapist supervision at the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital. The remaining 10 sessions will be done unsupervised at home, over approximately 4 weeks, and following the therapist home treatment plan. Over that time, 2 visits to Spaulding Rehabilitation will be made to review home treatment plan. Over the course of the study, participants will wear Axivity sensors to gather information about upper-extremity usage. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SynPhNe platform | Device | SynPhNe is a non-invasive device. It consists of a piece worn around the forearm, a head component and it communicates wirelessly with the computer to provide feedback while performing motor tasks with the hemiparetic hand. The head cap records brain activity and gives feedback to help relaxing while exercising. The arm and the head component communicate wirelessly with the computer via Bluetooth. The head component reads brain signals while the arm gear senses your muscle signals when performing the exercises. The computer software adopts the appropriate difficulty level, speed and duration of the exercise depending on brain and muscle status to minimize fatigue. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Upper Extremity - Motor | This is a motor function assessment for stroke survivors who have hemiplegia. Items are scored on a 3-point ordinal scale where 0=cannot perform, 1=performs partially, and 2=performs fully. Higher scores are indicative of higher function. Maximum score=66. | Week 0, Week 7, Week 11 |
| Box and Block Test | The test is an assessment of unilateral gross manual dexterity. It is performed with each hand separately, the stroke-affected hand and the non-affected hand. The scored is calculated by counting the number of blocks that were carried over the partition from one side of the box to the other side of the box in 1 minute. Higher scores are indicative of better gross manual dexterity. | Week 0, Week 7, Week 11 |
| Wolf Motor Function Test - Functional Ablility | This assessment evaluates motor ability of the upper extremity during timed and functional tasks. Functional ability scores are assigned using a 6-point ordinal scale, and the maximum score is 75. A score of 0=does not attempt with the involved arm and a score of 5=arm does participate; movement appears to be normal. Higher scores are indicative of higher function. | Week 0, Week 7, Week 11 |
| Wolf Motor Function Test - Performance Time | This assessment evaluates motor ability of the upper extremity during timed and functional tasks. Performance time is measured in seconds, with up to 120 seconds allowed. | Week 0, Week 7, Week 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Grip Strength | This is a measurement of maximal isometric hand grip strength in kilograms. A Jamar dynamometer will be utilized. | Week 0, Week 7, Week 11 |
| Visual Analogue Scale for Pain | This is an assessment of pain intensity from 0=no pain to 10=worse pain imaginable. |
| Measure | Description | Time Frame |
|---|---|---|
| Range of Motion -- Upper Extremity | Upper-extremity range of motion is assessed utilizing a goniometer. | Week 0, Week 7, Week 11 |
| Manual Muscle Testing | This is an assessment of muscle strength. Scores will be assigned according to the Kendall Muscle Strength Grading System. Scores range from 0 (no contraction felt or seen) to 5 (holds test position against strong pressure). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathy Piela, PT, DPT | Contact | 6179526388 | kpiela@mgb.org | |
| Motion Analysis Laboratory | Contact | 6179526331 |
| Name | Affiliation | Role |
|---|---|---|
| Paolo Bonato, PhD | Spaulding Rehabilitation Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Rehabilitation Hospital | Recruiting | Boston | Massachusetts | 02129 | United States |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Conventional therapy | Other | Exercise program established with a therapist (8 sessions under therapist direct supervision and 10 sessions at home). Low functioning subjects will be given more proximal joint-muscle exercises and activities while higher functioning subjects will have a greater component of distal tasks and activities. The therapist will review the exercises therapy plan with the subject and re-adjust it. |
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| Week 0, Week 7, Week 11 |
| Spasticity -- Modified Ashworth Scale | The upper extremity will be assessed for spasticity. Scores will be assigned based on the Modified Ashworth Scale. Scores range from from 0=no spasticity/ no increase in muscle tone) to 4=affected part(s) rigid in flexion or extension. | Week 0, Week 7, Week 11 |
| Motor Activity Log - Amount of Use | This outcome measure assesses upper extremity function and use through patient report. Items are scored using a 6-point ordinal scale. For the Amount Scale, 0=the weaker arm was not used at all for that activity (not used), while 5=the weaker arm was used as often as before the stroke (same as pre-stroke). The score is calculated by adding the rating scores for each item and dividing by the number of items asked. | Week 0, Week 7, Week 11 |
| EQ5D Questionnaire | This is a health questionnaire that evaluates quality of life in 5 dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depressions. Applicable to a wide range of health conditions and treatments, the EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status. Answers are coded as a number where 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=unable or extreme problems. An index score is calculated and ranges from 0=a state as bad as being dead to 1=full health. | Week 0, Week 7, Week 11 |
| Motor Activity Log - Quality of Movement | This outcome measure assesses upper extremity function and use through patient report. Items are scored using a 6-point ordinal scale. For the How Well Scale, 0=the weaker arm was not used at all for that activity (not used), while 5=the ability to use the weaker arm for that activity was as good as before the stroke (normal). The score is calculated by adding the rating scores for each item and dividing by the number of items asked. | Week 0, Week 7, Week 11 |
| Week 0, Week 7, Week 11 |
| Device Satisfaction Feedback Questionnaire (only for intervention group) | This questionnaire gathers satisfaction feedback about the usage of the device. Questions are scored from 1 to 5, with a total score up to 25. Higher scores indicate higher satisfaction with the device. | Week 7 |
| Systolic and Diastolic Blood Pressure | Blood pressure measurement is collected on the non-affected upper limb. Units are mmHg. | Week 0, Week 7, Week 11 |
| Number of Sessions Completed (only for intervention group) | This is a log of completed sessions recorded by the software. Higher numbers indicates better adherence to the intervention. | Week 7 |
| Number of Issues Encountered with the Device and/or Software (only for intervention group) | This is a recording of the number of occurrences of device and/or software malfunction. | Week 7 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |