Robotic Upper-Limb Neurorehabilitation in Chronic Stroke Patient

This study has been completed.
Sponsor:
Collaborator:
Massachusetts Institute of Technology
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00037934
First received: May 24, 2002
Last updated: October 6, 2011
Last verified: October 2011

May 24, 2002
October 6, 2011
April 2002
September 2004   (final data collection date for primary outcome measure)
Upper limb Motor Status Score, Wolf Motor Function Test, Motor Power Assessment, and Fugl-Meyer Upper Extremity Motor Performance Test [ Time Frame: The Primary Outcome measures were performed at baseline, after completion of 18 sessions of intervention and at 3 months follow-up. ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00037934 on ClinicalTrials.gov Archive Site
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Robotic Upper-Limb Neurorehabilitation in Chronic Stroke Patient
Evaluation of Robotic Upper Extremity Neuro-Rehabilitation

We have established the feasibility and effectiveness of robot-aided rehabilitation in stroke patients using a robot for neurological rehabilitation designed and built by MIT. Results of a pilot study of 20 patients were promising and showed that robot therapy is safe, tolerated by patients and produces a significant, measurable benefit. We propose to test that the robotic upper extremity trainer is an acceptable cost effective adjunct to standard occupational therapy for patients with dysfunction of the shoulder and elbow due to hemiparetic stroke in a VA rehabilitation program.

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Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Stroke
  • Device: Upper extremity robot
    Robotic upper extremity neuro-rehabilitation
  • Other: Traditional Supervised Upper Extremity Exercises
    Arm ergometer, reaching, and stretching exercises
  • Experimental: 1
    Robot exercise group
    Intervention: Device: Upper extremity robot
  • Active Comparator: 2
    Traditional exercise group
    Interventions:
    • Device: Upper extremity robot
    • Other: Traditional Supervised Upper Extremity Exercises
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2004
September 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Chronic Stroke
  • Manual Muscle Score of Grade 3 or lower in at least one muscle of the affected arm

Exclusion Criteria:

  • Acute Stroke
  • Contracture or orthopedic problems limiting the movement of the affected arm
  • Visual deficit such that the participant cannot see the test pattern on the robot trainer
  • Serious complicating medical illness
  • Botox treatment to the involved arm within three months of enrollment
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00037934
B2436
No
Department of Veterans Affairs
Department of Veterans Affairs
Massachusetts Institute of Technology
Principal Investigator: Christopher Bever, MD VA Maryland Health Care System, Baltimore
Department of Veterans Affairs
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP