The goal of this study is to: 1. Assess the usability of the SynPhNe device in a home environment. 2. Evaluate the efficacy of the SynPhNe home use device to improve motor hand function in chronic stroke subjects as compared to standard care alone.
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 lab-based upper-extremity research therapy in its content is similar to regular occupational therapy and will focus exercise movements of arm and hand. * The group testing the SynPhNe system at home will have the system lent at no cost. The study lasts for up to 12 weeks and involves up to 22 sessions in total: * Up to 3 sessions will be for testing arm movements (at baseline, after research therapy and at 1 month follow-up). * 18 research therapy sessions. 10 of them will be done at Spaulding Rehabilitation Hospital with a therapist and 8 of them by yourself, at home. Study participants will either be using the SynPhNe system or the therapy plan recommended by the therapist, depending on the randomization. Each of these visits will be an hour long. They will be scheduled 3 days per week for six weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
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.
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.
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States
RECRUITINGFugl-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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 0, Week 7, Week 11
Grip Strength
This is a measurement of maximal isometric hand grip strength in kilograms. A Jamar dynamometer will be utilized.
Time frame: Week 0, Week 7, Week 11
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Visual Analogue Scale for Pain
This is an assessment of pain intensity from 0=no pain to 10=worse pain imaginable.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 0, Week 7, Week 11