Evaluation of Robotic Arm Rehabilitation in Stroke Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00333983
First received: June 2, 2006
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to compare 2 training programs using robotic exercise devices to supervised arm exercises in stroke patients with chronic stable deficits.


Condition Intervention
Stroke
Device: Robotic Upper Extremity Neurorehabilitation
Other: Traditional Upper Extremity Exercise Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Robotic Arm Rehabilitation in Stroke Patients

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment [ Time Frame: Baseline to Final Training (6 weeks) ] [ Designated as safety issue: No ]

    The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia (Fugl-Meyer, Jaasko, Leyman, Olsson, & Steglind, 1975; Gladstone, Danells, & Black, 2002).

    Sections can be administered separately and the upper extremity motor portion of this measure was used as our primary outcome. Assessment items included movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. These items were scored on the basis of ability to complete using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully.

    The total possible score for the upper extremity is 66 with a minimum range of 0 and maximum of 66. A higher score indicates a better outcome.



Enrollment: 62
Study Start Date: June 2006
Study Completion Date: February 2011
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Robot Exercise Group
Device: Robotic Upper Extremity Neurorehabilitation
Upper extremity exercise using a planar robot Upper extremity exercise using a planar and vertical robot
Active Comparator: Arm 2
Traditional Upper Extremity Exercise Group
Other: Traditional Upper Extremity Exercise Group
Upper extremity stretching, skateboard reaching activities, and arm ergometer

Detailed Description:

A robotic exercise device has been developed(MIT-MANUS)capable of providing therapy to the arm for patients with weakness due to stroke. The randomized trial will compare conventional care, planar robot intervention and an intervention of planar and vertical robot training among patients with chronic, stable deficits. We will evaluate motor outcomes, effectiveness, cost, patient satisfaction and quality of life. The study will determine the efficacy of upper extremity robot therapy compared to supervised self-administered exercise therapy in patients with deficits due to stroke.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have a clinically, defined, unilateral, hemiparetic stroke with radiologic exclusion of other diagnoses
  • Stroke onset greater than six months before randomization for ischemic stroke patients and one year before randomization for hemorrhagic stroke patients
  • A grade 3 or lower in Manual Muscle Test in the hemiparetic elbow flexion and shoulder abduction

Exclusion Criteria:

  • Subjects unable to give informed consent
  • Serious complicating medical illness
  • Contracture or orthopedic problems limiting the range of joint movement in the study arm
  • Visual loss
  • Stroke occurred within 6 months for ischemic stroke patients, one year for hemorrhagic patients
  • Botox treatment within 3 months of enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00333983

Locations
United States, Maryland
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Investigators
Principal Investigator: Christopher Bever, MD VA Maryland Health Care System, Baltimore
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00333983     History of Changes
Other Study ID Numbers: B3833-R
Study First Received: June 2, 2006
Results First Received: August 30, 2013
Last Updated: February 3, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 22, 2014