NCT02896348 · Spaulding Rehabilitation Hospital
Assessment of a Physio-neuro Platform (SynPhNe) for Home-based Retraining of Hand Function in Stroke Survivors
What this study is about
The goal of this study is to: 1. Assess the usability of the SynPhNe device in a home environment. 2. Evaluate the effectiveness of the SynPhNe home use device to improve motor hand function in chronic stroke subjects as compared to standard care alone.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 6, 2026 · Source of record for eligibility and locations