Note: This study is currently only recruiting patients in the hospital.

If you are interested in being notified if this study begins recruiting from the general population, please use the 'I Am Interested' button below.

Do you have upper-extremity weakness due to a stroke?

The Motion Analysis Lab at Spaulding is testing a body-mind intergative system for upper-extremity rehabilitation in the clinic and home environment.

Spaulding Rehabilitation Network Stroke Rehabilitation Stroke Rehabilitation
22 visits over 12 weeks
Estimated Time Commitment
Female, Male, 21-80 years
May Be Eligible
Payment up to $310
May Be Offered
Survey, Office visit
May Be Required
 
I Am Interested I Am Interested I Am Interested

This project is not recruiting.

Overview

What we are studying

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.


We are combining the use of the device with a research oriented rehabilitation program in a supervised environment. The SynPhNe system is a class 2, 510(k) exempt and is listed under FDA SCFR Title 21, Chapter I, Sub Chapter H, Part 882 – Neurological devices (Biofeedback Device). Devices that are 510(k) exempt do not require FDA review.


Why it is important


What we hope to accomplish

Principal Investigator

Paolo Bonato, PhD

Spaulding Rehabilitation Network

Public Profile

Who can participate

Adults between 21 and 80 years of age:



  • Have suffered a stroke more than 6 months ago

  • Have upper-extremity weakness

  • Have some movements in fingers

Who cannot participate

You shouldn't volunteer if you have:



  • Cognitive impairment resulting to inability to follow instructions;  

  • 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 that limits comprehension and completion of the treatment protocol;

  • Previous diagnosis of dementia;

  • Other conditions affecting function of the stroke affected upper limb;

  • Severe pain in the stroke affected upper limb

  • History of seizures disorder and/or a seizure occuring within the last 6 months;

  • Are not able to provide us or give us access to brain imaging of their Stroke lesion.

What you may be asked to do

During the assessments visits (up to 3: baseline, end-of-intervention and follow-up): you will be asked to fill out questionnaires about your arm use in daily life and to perfrom test of arm movements. These sessions last for about 2 hours each. 


The research therapy program: 


For about 6 weeks, you will participate in 18 sessions of research therapy. Each session is about 60 minutes long. 8 sessions will happen at the hospital, the remaining 10 sessions will be done either at home or at the hospital under limited supervision. During these sessions, you will receive research therapy, we will focus on your arm movements, especially your wrist and hand.


You will be randomized to one of two groups (by chance, like a coin toss): 



  • If you are part of group 1: we will lend you the SynPhNe system so you can exercise at home, following the therapist recommendations. We will show you (and your caregiver if applicable) how to use the SynPhNe system at home.



  • If you are part of group 2: You will receive wrist sensors (like a watch) to wear during 4 weeks and a home-exercises program for your upper-limb. We will show you (and your caregiver if applicable) how to wear the wrist sensors and how to perform the exercises at home.


Project activities may include:

  • Survey
  • Office visit

Estimated Time Commitment

22 visits over 12 weeks

What You May Get

Participants will be compensated based on the number of sessions attended and may earn up to $310 for a complete participation. Parking will be provided on site. 

Location

Spaulding Rehabilitation Hospital
300 first ave. Charlestown, MA 02139

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Travel

  • Accessible by public transportation
  • Parking available
  • Parking reimbursed

Travel and Parking Details

Additional Information

ClinicalTrials.gov Identifier

NCT02896348


Participating Institutions


Funding Source

  • Industry
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