Wearable Robotic Functional Assistance for Stroke Rehabilitation

NCT ID: NCT00396708

Last Updated: 2010-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aims to evaluate the effectiveness of using the myomo e100 wearable robotic rehabilitation system for increasing functional independence and long term rehabilitation of chronic stroke victims with a hemiparetic upper extremity.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a case controlled study for evaluation of the effectiveness of using the myomo e100 wearable robotic rehabilitation for upper arm therapy following stroke.

The intervention for the study will be for the control group- 6-8 weeks of therapeutic exercise and functional training for a total of 18 hours of intervention, or the case group- 6-8 weeks of therapeutic exercise and functional training with the use of the AJB for a total of 18 hours of intervention. Each session will be one hour in length. The length of the study and length of each session is per standard rehabilitation protocol that has been well documented in previous studies as well as the pilot study regarding the AJB. A pre and post test with a 3 month follow up of all measures will be included in the study.

Study procedures will focus on performing functional tasks using the e100.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

CVA (Cerebrovascular Accident)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

myomo e100 neurorobotic elbow brace

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Medically Stable
* Cognitive Awareness
* Weakness in upper arm
* Over 1 year post CVA
* not engaged in any other upper arm therapies

Exclusion Criteria

* Rashes, open wounds or skin sensitivity on arm
* Very high elbow tone (arm rigid in flexion or extension)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Myomo

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Myomo,Inc

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kailas N Narendran, BS, MEng

Role: PRINCIPAL_INVESTIGATOR

Inventor

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

myomo Inc.

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://www.myomo.com/

Myomo Inc. Homepage

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Evaluation of Robot Assisted Neuro-Rehabilitation
NCT01253018 COMPLETED PHASE1/PHASE2