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

Conditions

• Hemiparesis
• Stroke

Eligibility Criteria

Sex

ALL

Age

21 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• SynPhNe platform — DEVICE
  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.
• Conventional therapy — OTHER
  Exercise program established with a therapist (8 sessions under therapist direct supervision and 10 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.

Study Details

The goal of this study is to: 1. Assess the usability of the SynPhNe device in a home environment. 2. Evaluate the efficacy of the SynPhNe home use device to improve motor hand function in chronic stroke subjects as compared to standard care alone.

Key Dates

Start date

Feb 26, 2025

Status verified

May 2026

Primary completion

Dec 31, 2026

Completion

Mar 31, 2027

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: SynPhNe 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 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. Over the course of the study, participants will wear Axivity sensors to gather information about upper-extremity usage.
• Active Comparator: Conventional therapy
  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 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 Axivity sensors to gather information about upper-extremity usage.

Primary Outcome Measure

Fugl-Meyer Upper Extremity - Motor [ Time Frame: Week 0, Week 7, Week 11 ]

Central Contacts

• Kathy Piela, PT, DPT
  6179526388
  [email protected]
• Motion Analysis Laboratory
  6179526331

Locations (1)

Find similar trials in Boston, MA

Related Studies

• Genetic and Environmental Risk Factors for Hemorrhagic Stroke
  Recruiting · State University of New York at Buffalo · Chicago, Illinois
• GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study
  Recruiting · W.L.Gore & Associates · Tucson, Arizona
• Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG
  PHASE3 · Recruiting · Icahn School of Medicine at Mount Sinai · Little Rock, Arkansas
• An Augmented Reality Based System for Neglect Detection, Assessment, and Rehabilitation
  Recruiting · University of Pittsburgh · Boston, Massachusetts