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Completed

NCT Number: NCT00396708

Wearable Robotic Functional Assistance for Stroke Rehabilitation

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.

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Key information

Conditions

CVA (Cerebrovascular Accident) Asthenia Brain Diseases Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nervous System Diseases Organizing Pneumonia Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

myomo Inc.

Boston, Massachusetts, 02129, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

myomo e100 neurorobotic elbow brace

Device

Primary outcomes

  1. Motor Activity Log

  2. Fugl-Meyer Upper Arm Function

  3. Wolf Motor Function

  4. SF-36 QOL Survey

  5. Range of Motion

  6. Muscle Strength Test

Sponsors and collaborators

Lead sponsor

Myomo

Industry

Registry information

Important dates

Study start
2006
Primary completion
2007
First posted
Nov 7, 2006
Registry last updated
Feb 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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