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New home gadget aims to restore hand control after stroke

NCT ID NCT02896348

Symptom relief Sponsor: Spaulding Rehabilitation Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a device called SynPhNe that stroke survivors can use at home to retrain their hand function. The goal is to see if it improves hand movement compared to standard care alone. The study will include 40 adults who had a stroke at least 6 months ago and have moderate arm weakness. Participants will use the device at home and be assessed on hand dexterity and strength.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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;

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Conditions

The condition(s) this trial relates to.

hemiplegia Paresis stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemiparesis Stroke

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Spaulding Rehabilitation Hospital

    RECRUITING

    Boston, Massachusetts, 02129, United States

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