Assessment of a Physio-neuro Platform (SynPhNe) for Home-based Retraining of Hand Function in Stroke Survivors

Not Applicable

Recruiting

• Conditions: Hemiparesis; Stroke

• Registration Number: NCT02896348
• Lead Sponsor: Spaulding Rehabilitation Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2016-08-18
• Study First Submitted QC: 2016-09-09
• Study First Posted: 2016-09-12
• Study Start: 2025-02-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-11
• Primary Completion: 2026-09
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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.

Exclusion Criteria

• 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;
• No more than moderate impairments in paretic UE sensation, passive range of motion, and pain that would limit ability to engage in therapy;
• Increased muscle tone as indicated by score of >/= 3 on the Modified Ashworth Scale;
• Previous diagnosis of dementia;
• Previous diagnosis of neurological diseases other than Stroke;
• History of seizures disorder and/or a seizure occuring within the last 6 months;
• Other conditions affecting function of the stroke affected upper limb;
• Severe pain in the stroke affected upper limb;
• Terminal diseases with expected survival <1 year;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Upper Extremity - Motor	Week 0, Week 7, Week 11	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	Week 0, Week 7, Week 11	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	Week 0, Week 7, Week 11	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	Week 0, Week 7, Week 11	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.

Secondary Outcome Measures

Name	Time	Method
Grip Strength	Week 0, Week 7, Week 11	This is a measurement of maximal isometric hand grip strength in kilograms. A Jamar dynamometer will be utilized.
Visual Analogue Scale for Pain	Week 0, Week 7, Week 11	This is an assessment of pain intensity from 0=no pain to 10=worse pain imaginable.
Spasticity -- Modified Ashworth Scale	Week 0, Week 7, Week 11	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	Week 0, Week 7, Week 11	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.
EQ5D Questionnaire	Week 0, Week 7, Week 11	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.
Motor Activity Log - Quality of Movement	Week 0, Week 7, Week 11	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.

Trial Locations

Locations (1)

Spaulding Rehabilitation Hospital; 🇺🇸 Boston, Massachusetts, United States