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Assessment of a Physio-neuro Platform (SynPhNe) for Home-based Retraining of Hand Function in Stroke Survivors (NCT02896348)

The goal of this study is to explore if the SynPhNe system can be used without difficulties in the home setting for upper extremity rehabilitation therapy for people who suffered a stroke.
  • Device: SynPhNe platform
    SynPhNe is a non-invasive device. It consists of a piece worn around the forearm, a head component and it communicates wirelessly with the computer to provide feedback while performing motor tasks with the hemiparetic hand. The head cap records brain activity and gives feedback to help relaxing while exercising. The arm and the head component communicate wirelessly with the computer via Bluetooth. The head component reads brain signals while the arm gear senses your muscle signals when performing the exercises. The computer software adopts the appropriate difficulty level, speed and duration of the exercise depending on brain and muscle status to minimize fatigue.
    • Other: Conventional therapy
      Exercise program established with a therapist (6 sessions under therapist direct supervision and 12 sessions at home). Low functioning subjects will be given more proximal joint-muscle exercises and activities while higher functioning subjects will have a greater component of distal tasks and activities. The therapist will review the exercises therapy plan with the subject and re-adjust it.
      Ages eligible for Study
      21 Years to 80 Years
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      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.
      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.

      1 locations

      United States (1)
      • Spaulding Rehabilitation Hospital
        not yet recruiting
        Boston, Massachusetts, United States, 02129
      Status:
      not yet recruiting
      Type:
      Interventional
      Phase:
      -
      Start:
      30 June, 2017
      Updated:
      19 March, 2017
      Participants:
      40
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