NCT02896348 Assessment of a Physio-neuro Platform (SynPhNe) for Home-based Retraining of Hand Function in Stroke Survivors
| NCT ID | NCT02896348 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Spaulding Rehabilitation Hospital |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-02-26 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-02-26 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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;
Contact & Investigator
Paolo Bonato, PhD
PRINCIPAL INVESTIGATOR
Spaulding Rehabilitation Hospital
Frequently Asked Questions
Who can join the NCT02896348 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 80 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02896348 currently recruiting?
Yes, NCT02896348 is actively recruiting participants. Contact the research team at kpiela@mgb.org for enrollment information.
Where is the NCT02896348 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT02896348 clinical trial?
NCT02896348 is sponsored by Spaulding Rehabilitation Hospital. The principal investigator is Paolo Bonato, PhD at Spaulding Rehabilitation Hospital. The trial plans to enroll 40 participants.
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