Assessment of a Physio-neuro Platform (SynPhNe) for Home-based Retraining of Hand Function in Stroke Survivors
Stroke, Hemiparesis
About this trial
This is an interventional treatment trial for Stroke focused on measuring Hemiparesis, Stroke, Rehabilitation, Home-based
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;
- Poor sitting balance (as assessed with the Berg Balance Test);
- 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;
- Not able to provide us or give us access to brain imaging of their Stroke lesion.
Sites / Locations
- Spaulding Rehabilitation Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
SynPhNe therapy
Conventional therapy
Subjects will be asked to participate in a program of 18 upper-extremity rehabilitation sessions of 60 minutes with SynPhNe platform, over 6 weeks. The sessions will emphasize on the wrist and fingers movements, including functional activities. During week the two first weeks, 6 sessions will be done under therapist supervision at the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital. Over the next 4 to 5 weeks, 10 sessions following exercises prompted by the SynPhNe system will be done unsupervised at home (or under limited supervision at the hospital), 2 sessions will be done at Spaulding Rehabilitation Hospital to review exercises with the SynPhNe system.
Subjects will be asked to participate in a program of 18 upper-extremity rehabilitation sessions of 60 minutes under therapist supervision over two weeks at the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital. The sessions will emphasize on the wrist and fingers movements, including functional activities. During week the two first weeks, 6 sessions will be done under therapist supervision at the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital. The remaining 10 sessions will be done unsupervised at home, over approximately 4 weeks, and following the therapist home treatment plan. Over that time, 2 visits to Spaulding Rehabilitation will be made to review home treatment plan. Over the course of the study, participants will wear GeneActiv sensors to gather information about upper-extremity usage.