Clinical trial NCT02896348: Assessment of a Physio-neuro Platform (SynPhNe) for Home-based Retraining of Hand Function in Stroke Survivors
Official title: Assessment of a Physio-neuro Platform (SynPhNe) for Home-based Retraining of Hand Function in Stroke Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Hemiparesis
Keywords: Hemiparesis
Stroke
Rehabilitation
Home-based
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Eligibility criteria: 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;

Primary outcomes:
measure: Fugl-Meyer Upper Extremity - Motor
timeFrame: Week 0, Week 7, Week 11
measure: Box and Block Test
timeFrame: Week 0, Week 7, Week 11
measure: Wolf Motor Function Test - Functional Ablility
timeFrame: Week 0, Week 7, Week 11
measure: Wolf Motor Function Test - Performance Time
timeFrame: Week 0, Week 7, Week 11
Secondary outcomes:
measure: Grip Strength
timeFrame: Week 0, Week 7, Week 11
measure: Visual Analogue Scale for Pain
timeFrame: Week 0, Week 7, Week 11
measure: Spasticity -- Modified Ashworth Scale
timeFrame: Week 0, Week 7, Week 11
measure: Motor Activity Log - Amount of Use
timeFrame: Week 0, Week 7, Week 11
measure: EQ5D Questionnaire
timeFrame: Week 0, Week 7, Week 11
measure: Motor Activity Log - Quality of Movement
timeFrame: Week 0, Week 7, Week 11
Other outcomes:
measure: Range of Motion -- Upper Extremity
timeFrame: Week 0, Week 7, Week 11
measure: Manual Muscle Testing
timeFrame: Week 0, Week 7, Week 11
measure: Device Satisfaction Feedback Questionnaire (only for intervention group)
timeFrame: Week 7
measure: Systolic and Diastolic Blood Pressure
timeFrame: Week 0, Week 7, Week 11
measure: Number of Sessions Completed (only for intervention group)
timeFrame: Week 7
measure: Number of Issues Encountered with the Device and/or Software (only for intervention group)
timeFrame: Week 7
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Paolo Bonato, PhD
role: PRINCIPAL_INVESTIGATOR
References: