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.
Ischemic or hemorrhagic stroke at least 6 months prior study enrollment ;
Moderate upper-extremity hemiparesis (initial score on the Upper Extremity Fugl-Meyer Assessment between 21 and 55 out of 66) ;
Ability to extend at least 2 fingers in the affected hand 10 degrees at any joint with pain-free passive range of motion at least 50% in all joints below the elbow.
Cognitive impairment resulting to inability to follow instructions (as assessed with the MMSE) and inability to sustain attention for more than 10 minutes;
Current participation in upper-extremity therapy program;
Treatment with Botox injections in the affected arm in the previous 3 months and no planned Botox injections before the end of the study;
Aphasia sufficient to limit comprehension and completion of the treatment protocol;
Parallel
SynPhNe platform
DeviceSynPhNe 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.
Conventional therapy
Other interventionExercise 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.
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.
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.
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.
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.
Grip Strength
This is a measurement of maximal isometric hand grip strength in kilograms. A Jamar dynamometer will be utilized.
Visual Analogue Scale for Pain
This is an assessment of pain intensity from 0=no pain to 10=worse pain imaginable.
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.
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.
Range of Motion -- Upper Extremity
Upper-extremity range of motion is assessed utilizing a goniometer.
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).
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.
Systolic and Diastolic Blood Pressure
Blood pressure measurement is collected on the non-affected upper limb. Units are mmHg.
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