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

NCT02896348 | Recruiting FDA Device

• 1 other identifier: 2016-P-000666
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to:

1. 1.Assess the usability of the SynPhNe device in a home environment.
2. 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.

Conditions

Stroke; Hemiparesis

Keywords

Hemiparesis; Stroke; Rehabilitation; Home-based

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Grip Strength

  Week 0, Week 7, Week 11

• Visual Analogue Scale for Pain

  Week 0, Week 7, Week 11

• Spasticity -- Modified Ashworth Scale

  Week 0, Week 7, Week 11

• Motor Activity Log - Amount of Use

  Week 0, Week 7, Week 11

• EQ5D Questionnaire

  Week 0, Week 7, Week 11

Other Outcomes (6)

• Range of Motion -- Upper Extremity

  Week 0, Week 7, Week 11

• Manual Muscle Testing

  Week 0, Week 7, Week 11

• Device Satisfaction Feedback Questionnaire (only for intervention group)

  Week 7

Study Arms (2)

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.

Device: SynPhNe platform

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.

Other: Conventional therapy

Interventions

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.

SynPhNe therapy

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.

Conventional therapy

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02129, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paolo Bonato, PhD

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathy Piela, PT, DPT

CONTACT

6179526388; kpiela@mgb.org

Motion Analysis Laboratory

CONTACT

6179526331

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: September 12, 2016
• Study Start: February 26, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)