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

Not yet recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Conventional therapy Other
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Conventional therapy
    Description: Subjects will be asked to participate in a program of 6 upper-extremity rehabilitation sessions of 60 minutes under therapist supervision over two weeks at the MAL. The sessions will emphasize on the wrist and fingers movements, including functional activities. The remaining 12 sessions will be done unsupervised at home, over approximately 4 weeks, and following the therapist home treatment plan.
  • SynPhNe platform Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: SynPhNe therapy
    Description: Subjects will be asked to participate in a program of 6 upper-extremity rehabilitation sessions of 60 minutes with SynPhNe platform under therapist supervision over two weeks at the MAL. The sessions will emphasize on the wrist and fingers movements, including functional activities. The remaining 12 sessions will be done unsupervised at home, over approximately 4 weeks, and following exercises from SynPhNe platform.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer Upper Extremity Changes from baseline Fulg-Meyer scores at 7 weeks and at one month follow-up No
Primary Caregiver Strain Index Changes from Caregiver Strain Index scores at 7 weeks and at one month follow-up No
Secondary Upper extremity Range of Motion at Baseline, at 7 weeks, at one month follow-up No
Secondary Upper extremity manual muscle testing at Baseline, at 7 weeks, at one month follow-up No
Secondary Modified Ashworth Scale at Baseline, at 7 weeks, at one month follow-up No
Secondary Jamar dynamometer at Baseline, at 7 weeks, at one month follow-up No
Secondary Visual Analogue Scale at Baseline, at 7 weeks, at one month follow-up No
Secondary Wolf Motor Function Test (Upper Extremity) at Baseline, at 7 weeks, at one month follow-up No
Secondary Box and Block test at Baseline, at 7 weeks, at one month follow-up No
Secondary EQ5D questionnaire at Baseline, at 7 weeks, at one month follow-up No

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