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Evaluation of Robotic Arm Rehabilitation in Stroke Patients

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Robotic Upper Extremity Neurorehabilitation
Traditional Upper Extremity Exercise Group
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Maryland Health Care System, Baltimore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Robot Exercise Group

Traditional Upper Extremity Exercise Group

Outcomes

Primary Outcome Measures

Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment
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.

Secondary Outcome Measures

Full Information

First Posted
June 2, 2006
Last Updated
February 3, 2014
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00333983
Brief Title
Evaluation of Robotic Arm Rehabilitation in Stroke Patients
Official Title
Evaluation of Robotic Arm Rehabilitation in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Robot Exercise Group
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Traditional Upper Extremity Exercise Group
Intervention Type
Device
Intervention Name(s)
Robotic Upper Extremity Neurorehabilitation
Intervention Description
Upper extremity exercise using a planar robot Upper extremity exercise using a planar and vertical robot
Intervention Type
Other
Intervention Name(s)
Traditional Upper Extremity Exercise Group
Intervention Description
Upper extremity stretching, skateboard reaching activities, and arm ergometer
Primary Outcome Measure Information:
Title
Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment
Description
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.
Time Frame
Baseline to Final Training (6 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Bever, MD
Organizational Affiliation
VA Maryland Health Care System, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Maryland Health Care System, Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21849168
Citation
Conroy SS, Whitall J, Dipietro L, Jones-Lush LM, Zhan M, Finley MA, Wittenberg GF, Krebs HI, Bever CT. Effect of gravity on robot-assisted motor training after chronic stroke: a randomized trial. Arch Phys Med Rehabil. 2011 Nov;92(11):1754-61. doi: 10.1016/j.apmr.2011.06.016. Epub 2011 Aug 17.
Results Reference
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Evaluation of Robotic Arm Rehabilitation in Stroke Patients

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