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New treatment option for Stroke
Official title Assessment of a Physio-neuro Platform (SynPhNe) for Home-based Retraining of Hand Function in Stroke Survivors
ClinicalTrials.gov ID: NCT02896348
What this study is testing
- What it's testing
- The goal of this study is to: 1. Assess the usability of the SynPhNe device in a home environment.
- Time commitment: about 12 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 80
You may be able to join if
- 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...
You likely can't join if
- Cognitive impairment resulting to inability to follow instructions (as assessed with the MMSE) and inability to sustain attention for more than 10...
- 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;
See the full eligibility 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.
- 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;
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Compensation & support
Some study costs may be covered.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.