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Pilot Study - Comparison of Upper Body Ergometer Vs. Robot in Upper Extremity Motor Recovery Post-Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Robot
Ergometer
Sponsored by
Burke Rehabilitation Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke.Robot.Ergometer.Group OT

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with a recent acute stroke in the last 4 weeks Patients with an upper extremity plegia (Medical Research Council [MRC] grade 2 or less at the shoulder joint), Patients or their next of kin (in the absence of their being able to) provide with a written informed consent. Aphasic alert patients provided they could follow simple directions given by verbal or gestural cues. Exclusion criteria: Patients with anterior or severe inferior shoulder subluxation (3 cms) of the plegic arm Patients without shoulder pain on passive range of 75 degrees forward flexion and 75 degrees abduction of the plegic arm Patients with trophic skin changes and significant edema (shoulder-hand syndrome) Patients with prior rotator cuff surgery, patients with bursitis and/or biceps tendonitis Patients who have suffered recent cardiac events (myocardial infarction, congestive cardiac failure, recent coronary artery bypass surgery) Patients who refuse to sign a written informed consent.

Sites / Locations

  • Burke Rehabilitation Hospital

Outcomes

Primary Outcome Measures

Functional Independence Measure (FIM™)

Secondary Outcome Measures

The Fugl-Meyer Assessment (FMA) scale
Motor Status Scale (MSS)
Medical Research Council (MRC)
Motor Power Scale (MPS) Action Research Arm Test (ARAT)
Modified Ashworth scale (MAS)

Full Information

First Posted
June 20, 2006
Last Updated
June 20, 2006
Sponsor
Burke Rehabilitation Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00343304
Brief Title
Pilot Study - Comparison of Upper Body Ergometer Vs. Robot in Upper Extremity Motor Recovery Post-Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
April 2005
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Burke Rehabilitation Hospital

4. Oversight

5. Study Description

Brief Summary
We will test whether robot driven, goal directed, trajectory corrected exercise enhances motor outcome in the upper limb of stroke patients better than matched motor activity on an upper body ergometer (monark).
Detailed Description
Upper extremity (UE) weakness post-stroke occurs in 70-80% of patients. By 3 months this complaint persists in 40% of patients, and by 6 months this complaint persists in a similar percentage of patients (1). Greater improvement in motor functional recovery was achieved in patients with intact sensation. Shoulder pain persisted in 20% of patients (2). Most of the arm recovery occurs in the initial 3 months post-stroke (2,3,4). The Copenhagen stroke study found 79% of patients with mild UE paresis achieving functional motor recovery compared to 18% of patients with severe UE paresis (4). Katrak P et al. found early shoulder shrug and synergistic hand movements to be useful bedside predictors of functional motor recovery of the UE (5). The initial grade of paresis (measured on admission in the hospital) is the most important predictor of motor recovery after stroke, with initial paralysis implying the worst prognosis for subsequent motor recovery (6). Perceptual inattention does impact upon UE action and functional recovery (7). The UE weakness and functional motor recovery lags behind lower extremity (LE) weakness and functional motor recovery because of the complexity of motor skills needed for daily living tasks. Due to the persistence of upper extremity weakness, different rehabilitation techniques such as Constraint Induced (CI) (8,9,10) and robotic (11,12,13) therapies were developed to help with meaningful functional motor recovery in the paretic arm (unilateral arm training). Both of these forced-use interventions focus on the paretic arm only. The main drawback of the CI therapy is that subjects need to have some degree of voluntary movement both at the wrist and the digits. Bilateral arm training with rhythmic clueing (BATRAC) has been used in chronic stroke patients and has been found to improve functional motor performance in the paretic UE (14). The authors in a recent paper showed BATRAC inducing reorganization in contraleisonal motor networks based on functional MRI (15). Facilitation of paretic arm movement by the non-paretic arm (bimanual movement) is thought to be superior to individual paretic arm movement, which indicates both arms to be a coordinated brain unit (16). Richards L et al., in their review article (17) and Vander Lee J et al., in their meta-analysis of randomized stroke trials (18) on therapeutic interventions to improve UE function, found extensive practice to be the most important factor irrespective of the type of intervention instituted. Early repetitive sensorimotor stimulation of the arm results in long-lasting functional motor recovery (19). The overall goal of this study is to determine whether bilateral arm training with upper body ergometer is as or more effective in upper extremity functional recovery than unilateral arm training with robot in patients with a recent ischemic and hemorrhagic stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke.Robot.Ergometer.Group OT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Robot
Intervention Type
Device
Intervention Name(s)
Ergometer
Primary Outcome Measure Information:
Title
Functional Independence Measure (FIM™)
Secondary Outcome Measure Information:
Title
The Fugl-Meyer Assessment (FMA) scale
Title
Motor Status Scale (MSS)
Title
Medical Research Council (MRC)
Title
Motor Power Scale (MPS) Action Research Arm Test (ARAT)
Title
Modified Ashworth scale (MAS)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a recent acute stroke in the last 4 weeks Patients with an upper extremity plegia (Medical Research Council [MRC] grade 2 or less at the shoulder joint), Patients or their next of kin (in the absence of their being able to) provide with a written informed consent. Aphasic alert patients provided they could follow simple directions given by verbal or gestural cues. Exclusion criteria: Patients with anterior or severe inferior shoulder subluxation (3 cms) of the plegic arm Patients without shoulder pain on passive range of 75 degrees forward flexion and 75 degrees abduction of the plegic arm Patients with trophic skin changes and significant edema (shoulder-hand syndrome) Patients with prior rotator cuff surgery, patients with bursitis and/or biceps tendonitis Patients who have suffered recent cardiac events (myocardial infarction, congestive cardiac failure, recent coronary artery bypass surgery) Patients who refuse to sign a written informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meheroz H Rabadi, MD, MRCPI
Organizational Affiliation
Burke Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Burke Rehabilitation Hospital
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States

12. IPD Sharing Statement

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Pilot Study - Comparison of Upper Body Ergometer Vs. Robot in Upper Extremity Motor Recovery Post-Stroke

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