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SynPhNe Platform for Hand Function After Stroke

This study is testing a device called SynPhNe for improving hand function in people who have had a stroke. SynPhNe is a non-invasive device worn on the forearm and head that provides feedback while you do hand exercises. The study aims to see if SynPhNe can be easily used at home and if it helps improve hand movement more than standard therapy. You might be able to join if you are 21-80 years old, had a stroke at least 6 months ago, and have moderate weakness (hemiparesis) in your arm and hand. Success will be measured by improvements in hand and arm movement tests. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 40 participants. Participants will be randomly assigned to either use the SynPhNe system at home or receive conventional therapy.
What's involved
The study lasts up to 12 weeks and involves up to 22 sessions. This includes up to 3 testing sessions and 18 therapy sessions.
Compensation
The SynPhNe system will be lent at no cost to participants in that group. Not stated in the trial record if participants are otherwise compensated.
Follow-up
Hand and arm movement will be tested at the beginning of the study (Week 0), after therapy (Week 7), and one month later (Week 11).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02896348

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

Recruiting
NAAges 21–80InterventionalTreatment
Spaulding Rehabilitation Hospital
~40 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:SynPhNe platformConventional therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fugl-Meyer Upper Extremity - Motor
Measured over Week 0, Week 7, Week 11
+3 more outcomes measured

Conditions

Stroke
Hemiparesis

Explore related trials

HemiparesisStroke

NCT02896348

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Spaulding Rehabilitation Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Paolo Bonato, PhD · PRINCIPAL_INVESTIGATOR · Spaulding Rehabilitation Hospital

Who to contact

Kathy Piela, PT, DPT
[email protected]
6179526388
Email the study team

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Eligibility criteria

Inclusion

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

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;

What this trial measures

  • Fugl-Meyer Upper Extremity - MotorWeek 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 TestWeek 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 AblilityWeek 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 TimeWeek 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.