Stroke Clinical Trial - Assessment of a Physio-neuro Platform (SynPhNe)

Status Not yet recruiting

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02896348
Study type	Interventional
Source	Spaulding Rehabilitation Hospital
Contact	Catherine P Adans-Dester
Phone	6179526321
Email	cadans-dester@partners.org
Status	Not yet recruiting
Phase	N/A
Start date	January 2024
Completion date	December 2024

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms