Home-based retraining of hand function for stroke survivors using a new device
Assessment of a Physio-neuro Platform (SynPhNe) for Home-based Retraining of Hand Function in Stroke Survivors
This study is testing a new home device to see if it can help stroke survivors improve their hand function better than traditional therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | Spaulding Rehabilitation Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT02896348 on ClinicalTrials.gov |
What this trial studies
This study evaluates the usability and effectiveness of the SynPhNe device, designed for home use, in improving hand function among chronic stroke survivors. Participants will be randomly assigned to either use the SynPhNe system at home or receive conventional lab-based therapy. The device, which includes a forearm component and a head cap for monitoring brain activity, aims to provide feedback during motor tasks to enhance rehabilitation outcomes. The study will last up to 12 weeks and involve a total of 22 therapy sessions, combining both home and lab-based exercises.
Who should consider this trial
Good fit: Ideal candidates are individuals who have experienced a stroke at least 6 months prior and have moderate upper-extremity hemiparesis.
Not a fit: Patients with severe cognitive impairments or those currently engaged in upper-extremity therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance hand function recovery for stroke survivors in a convenient home setting.
How similar studies have performed: Other studies have shown promise in home-based rehabilitation approaches, but the specific use of the SynPhNe device is novel.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
Boston, Massachusetts
- Spaulding Rehabilitation Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Paolo Bonato, PhD — Spaulding Rehabilitation Hospital
- Study coordinator: Kathy Piela, PT, DPT
- Email: kpiela@mgb.org
- Phone: 6179526388
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.