Recruiting

SynPhNe

Sponsor:

Spaulding Rehabilitation Hospital

Code:

NCT02896348

Conditions

Stroke

Hemiparesis

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

SynPhNe platform

Conventional therapy

Study Details

Brief summary:

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.

Conditions

Stroke

Hemiparesis

Study ID

NCT02896348

Start date

Feb 26, 2025

Status verified date

May, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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;
  • 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;

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

Conventional therapy

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.

Primary outcome measure

  • Fugl-Meyer Upper Extremity - Motor [ Time Frame: Week 0, Week 7, Week 11 ]
  • Box and Block Test [ Time Frame: Week 0, Week 7, Week 11 ]
  • Wolf Motor Function Test - Functional Ablility [ Time Frame: Week 0, Week 7, Week 11 ]
  • Wolf Motor Function Test - Performance Time [ Time Frame: Week 0, Week 7, Week 11 ]

Central Contacts and Locations

Central contacts

Kathy Piela, PT, DPT

6179526388kpiela@mgb.org

Motion Analysis Laboratory

6179526331

Locations

Spaulding Rehabilitation Hospital

Recruiting

Boston, Massachusetts, United States, 02129

Contacts

Kathy Piela, PT, DPT

617-952-6388kpiela@mgb.org

Motion Analysis Laboratory

617-952-6331

Principal Investigator:

Paolo Bonato, PhD

More Information

Sponsor

Spaulding Rehabilitation Hospital

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

  • Hemiparesis
  • Stroke
  • Rehabilitation
  • Home-based

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Spaulding Rehabilitation Hospital on 2026-05-06.