Assessment of a Physio-neuro Platform (SynPhNe) for Home-based Retraining of Hand Function in Stroke Survivors

The goal of this study is to explore if the SynPhNe system can be used easily at home for
people who suffered a stroke. With this study, we are also investigating if the SynPhNe
system used could improve your hand function when it is used with a few sessions of research
therapy.

SynPhNe is a non-invasive device. It consists of a piece worn around the forearm, a head
component and it communicates wirelessly via Bluetooth with the computer to provide subject
with feedback while performing motor tasks with their hand. The head cap records your brain
activity and gives feedback to help relaxing while exercising.

We are combining the use of the device with a research oriented rehabilitation program in a
supervised environment. The SynPhNe system has not been approved by the U.S. Food and Drug
Administration.

Subjects will be randomized by chance (like a coin toss) to one of the two groups: lab-based
upper extremity research therapy alone or lab-based upper extremity research therapy in
addition to the SynPhNe system for home-based exercises.

- The lab-based upper-extremity research therapy in its content is similar to regular
occupational therapy and will focus exercise movements of arm and hand.

- The group testing the SynPhNe system at home will have the system lent at no cost.

The study last for up to 12 weeks and involves up to 22 sessions in total:

- Up to 3 sessions will be for testing arm movements (at baseline, after research therapy
and at 1 month follow-up).

- 18 research therapy sessions. 10 of them will be done at Spaulding Rehabilitation
Hospital with a therapist and 8 of them by yourself, at home. Subjects will either be
using the SynPhNe system or use the therapy plan recommended by the therapist, depending
on the randomization. Each of these visits will be an hour long. They will be scheduled
3 days per week for six weeks.

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.

- Prospective subjects must have a computer and internet connection at home which they
will use for the home-based therapy.

Exclusion Criteria:

- Cognitive impairment resulting to inability to follow instructions (MMSE < 23 and
subject is able to follow the 3-Stage Command) 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 6 months;

- Poor sitting balance (score <4 on item number 3 of 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;

- 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.