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

Mass General Brigham

Status: Enrolling

Conditions: Stroke; Hemiparesis

Treatments: Device: SynPhNe platform; Other: Conventional therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02896348

2016-P-000666

Details and patient eligibility

About

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.

Full 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 in comparison to conventional 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.

The SynPhNe system has not been approved by the U.S. Food and Drug Administration.

Study participants will be randomized by chance (like a coin toss) to one of the two groups: lab-based upper extremity research therapy or 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 lasts 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. Study participants will either be using the SynPhNe system or 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

SynPhNe therapy

Experimental group

Description:

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.

Treatment:

Device: SynPhNe platform

Conventional therapy

Active Comparator group

Description:

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.

Treatment:

Other: Conventional therapy