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

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 when used with a few sessions of standard care, as compared to standard care alone.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Hemiparesis
• Intervention / Treatment: Device: SynPhNe platform; Other: Conventional therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02129
      • Spaulding Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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;
• Poor sitting balance (as assessed with 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;
• 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;
• Not able to provide us or give us access to brain imaging of their Stroke lesion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 on the 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.	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.
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 on the 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 GeneActiv sensors to gather information about upper-extremity usage.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Upper Extremity	FM-UE is a measure of upper-extremity motor impairment including coordination and speed.	Changes from baseline Fugl-Meyer scores at 7 weeks and at one month follow-up
Box and Block test	Gross motor manual dexterity assessment	Changes from baseline scores at 7 week and at one month follow-up
Wolf Motor Function Test (Upper Extremity)	of 17 items that are upper extremity motor tasks and that can assess movement components required for daily tasks.	Changes from baseline scores at Baseline, at 7 weeks and at one month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Jamar dynamometer	Hand grip strength	Changes from baseline scores at Baseline, at 7 weeks and at one month follow-up
Visual Analogue Scale for Pain	Assessment of pain intensity from 0 (no pain) to 10 (worse pain experienced)	Changes from baseline scores at Baseline, at 7 weeks and at one month follow-up
Modified Ashworth Scale	Measure of spasticity of Upper Extremity, score range from 0 (no spasticity) to 4 (Passive movement no possible)	Changes from baseline scores at Baseline, at 7 weeks and at one month follow-up
Systolic and Diastolic Blood Pressure	Arm measured blood Pressure	Changes from baseline scores at Baseline, at 7 weeks and at one month follow-up
Motor Activity Log	Measure of amount and quality of arm use in daily life	Changes from baseline scores at Baseline, at 7 weeks and at one month follow-up
EQ5D questionnaire	Assessment of Quality of life	Changes from baseline scores at Baseline, at 7 weeks and at one month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Goniometry - Active Range of Motion	Upper-extremity range of motion	Changes from baseline scores at Baseline, at 7 weeks and at one month follow-up
Manual Muscle Testing (Kendall)	Muscle strength assessed by a therapist following Kendall guidelines. Scores range from 0 (no contraction) to 5 (maximum strength)	Changes from baseline scores at Baseline, at 7 weeks and at one month follow-up
WHO-ICF problem solving form	Identification of participant's problems at the function, activity and environmental factors levels, following the World Health Organization International Classification of Functioning Codes. Decrease in number of problems identified at baseline indicates better outcomes.	Changes from baseline scores at Baseline, at 7 weeks and at one month follow-up
Device satisfaction feedback questionnaire (only for intervention group)	Questionnaire to gather satisfaction feedback about usage of the device. Questions are scored from 1 to 5, total score up to 25. Higher score indicate higher satisfaction with the device.	Scores at 7 weeks
Number of sessions completed (only for intervention group)	Log of completed sessions by the software. Higher number indicates better adherence to the intervention.	Scores at 7 weeks
Number of issues encountered with the device and/or software (only for intervention group)	Number of occurrences of device and/or software malfunction.	Scores at 7 weeks

Collaborators and Investigators

• Sponsor: Spaulding Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2024
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: August 18, 2016
• First Submitted That Met QC Criteria: September 9, 2016
• First Posted (Estimate): September 12, 2016

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Stroke; Hemiparesis; Home-based
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Paresis
• Other Study ID Numbers: 2016-P-000666

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No