NCT00396708

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Last Updated

February 3, 2010

Status Verified

February 1, 2010

Enrollment Period

1.3 years

First QC Date

November 3, 2006

Last Update Submit

February 2, 2010

Conditions

CVA (Cerebrovascular Accident)

Keywords

RoboticsRehabilitationArmStrokeWeaknessOutpatientChronic

Outcome Measures

Primary Outcomes (6)

  • Motor Activity Log

  • Fugl-Meyer Upper Arm Function

  • Wolf Motor Function

  • SF-36 QOL Survey

  • Range of Motion

  • Muscle Strength Test

Interventions

myomo e100 neurorobotic elbow braceDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Rashes, open wounds or skin sensitivity on arm
  • Very high elbow tone (arm rigid in flexion or extension)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

myomo Inc.

Boston, Massachusetts, 02129, United States

Location

Related Links

MeSH Terms

Conditions

StrokeAstheniaBronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Officials

  • Kailas N Narendran, BS, MEng

    Inventor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 3, 2006

First Posted

November 7, 2006

Study Start

August 1, 2006

Primary Completion

December 1, 2007

Last Updated

February 3, 2010

Record last verified: 2010-02

Locations

US(1)