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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Hemiparesis
• Intervention / Treatment: Device: SynPhNe platform; Other: Conventional therapy

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kathy Piela, PT, DPT; Phone Number: 6179526388; Email: kpiela@mgb.org
• Study Contact Backup: Name: Motion Analysis Laboratory; Phone Number: 6179526331

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02129
      • Recruiting
      • Spaulding Rehabilitation Hospital
      • Principal Investigator: Paolo Bonato, PhD
      • Contact: Kathy Piela, PT, DPT; Phone Number: 617-952-6388; Email: kpiela@mgb.org
      • Contact: Motion Analysis Laboratory; Phone Number: 617-952-6331

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SynPhNe therapy; 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.	Device: SynPhNe platform; 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.
Active Comparator: Conventional therapy; 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.	Other: Conventional therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Other Outcome Measures

Outcome Measure	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).	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

Collaborators and Investigators

• Sponsor: Spaulding Rehabilitation Hospital
• Investigators: Principal Investigator: Paolo Bonato, PhD, Spaulding Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: August 18, 2016
• First Submitted That Met QC Criteria: September 9, 2016
• First Posted (Estimated): September 12, 2016

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Rehabilitation; Stroke; Hemiparesis; Home-based
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Stroke; Paresis
• Other Study ID Numbers: 2016-P-000666

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No