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Effect of Robot Rehabilitation Exercise Training on Motor Control After Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Robotic arm therapy
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

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

Inclusion Criteria:

  1. Hemiparesis of the upper extremity
  2. Diagnosis of a first clinically apparent ischemic stroke at least 6 months prior to study entry
  3. Age 18 years or older
  4. Ability to sit and be active for an hour on a chair (or wheelchair) without cardiac, respiratory disturbances and/or pain.

Exclusion Criteria:

  1. Inability to understand and/or follow instructions
  2. Pain in shoulder or arm
  3. Other neurological or musculoskeletal target organ disorder
  4. Inability to give informed consent personally
  5. Previous or current contracture of the upper extremity

Sites / Locations

  • Columbia Univeristy, Neurological Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Robot arm rehabilitation therapy

Arm Description

Arm training using the ReoGo robotic device, 3 times a week for 3 weeks.

Outcomes

Primary Outcome Measures

Change in Arm Motor Control From Baseline Measured as Average Squared Mahalanobis Distance
Arm motor control was assessed through analysis of reaching movements to targets. We derive a measure of arm motor control using functional principal components analysis of reaching trajectories (average squared Mahalanobis distance). This is a unitless measure and lower change values reflect improvement in motor control, while a higher change value reflect a worsening in motor control.

Secondary Outcome Measures

Fugl-Meyer (FM) Upper Extremity Motor Assessment
The FM is a measure of impairment that considers movement arm, wrist, hand, and coordination. Each of the 22 items is scored on a three-point ordinal scale for total score between a minimum score of 0 and a maximum score of 66. A higher score indicates a better outcome.
Action Research Arm Test
The ARAT tests hand and arm function and consists of 19 items in 4 domains: grasp, grip, pinch, and gross movement. Each domain contains items arranged into hierarchical order of difficulty such that success at the most difficult item of a specific subclass assumes success for all items lower in the hierarchy of the same class. Each item is scored on a four-point ordinal scale for total score between a minimum score of 0 and a maximum score of 57. A higher score indicates a better outcome.

Full Information

First Posted
January 1, 2015
Last Updated
April 18, 2019
Sponsor
Columbia University
Collaborators
Orentreich Family Foundation, Mailman School of Public Health
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1. Study Identification

Unique Protocol Identification Number
NCT02331407
Brief Title
Effect of Robot Rehabilitation Exercise Training on Motor Control After Stroke
Official Title
Effect of Robot Rehabilitation Exercise Training on Motor Control After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University
Collaborators
Orentreich Family Foundation, Mailman School of Public Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Stroke is a leading cause of neurological disability worldwide, often causing significant weakening and paresis of the affected arm. National spending on post-stroke rehabilitation is project to expand 20% to 35% through 2010. As a new tool for therapists, robotic stroke therapy devices have the potential to be a cost-effective device aid to physical therapy and enable novel modes of exercise not currently available. While recent studies have shown chronic patients benefit from repetitive practice, it is not clear whether they improved via a reduction in impairment or increased functional compensation because there is a lack of standard treatment and scales to assess rehabilitation efficacy in chronic stroke patients. This study aims to reconcile difference performance measurements in robotic rehabilitation to assess the outcome of robotic rehabilitation training.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robot arm rehabilitation therapy
Arm Type
Experimental
Arm Description
Arm training using the ReoGo robotic device, 3 times a week for 3 weeks.
Intervention Type
Device
Intervention Name(s)
Robotic arm therapy
Intervention Description
Training with the ReoGo device
Primary Outcome Measure Information:
Title
Change in Arm Motor Control From Baseline Measured as Average Squared Mahalanobis Distance
Description
Arm motor control was assessed through analysis of reaching movements to targets. We derive a measure of arm motor control using functional principal components analysis of reaching trajectories (average squared Mahalanobis distance). This is a unitless measure and lower change values reflect improvement in motor control, while a higher change value reflect a worsening in motor control.
Time Frame
From baseline to within 1 week post-therapy
Secondary Outcome Measure Information:
Title
Fugl-Meyer (FM) Upper Extremity Motor Assessment
Description
The FM is a measure of impairment that considers movement arm, wrist, hand, and coordination. Each of the 22 items is scored on a three-point ordinal scale for total score between a minimum score of 0 and a maximum score of 66. A higher score indicates a better outcome.
Time Frame
baseline (1 and 3 weeks prior to therapy), within 1 week after therapy, 3 weeks after therapy
Title
Action Research Arm Test
Description
The ARAT tests hand and arm function and consists of 19 items in 4 domains: grasp, grip, pinch, and gross movement. Each domain contains items arranged into hierarchical order of difficulty such that success at the most difficult item of a specific subclass assumes success for all items lower in the hierarchy of the same class. Each item is scored on a four-point ordinal scale for total score between a minimum score of 0 and a maximum score of 57. A higher score indicates a better outcome.
Time Frame
baseline (1 and 3 weeks prior to therapy), within 1 week after therapy, 3 weeks after therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hemiparesis of the upper extremity Diagnosis of a first clinically apparent ischemic stroke at least 6 months prior to study entry Age 18 years or older Ability to sit and be active for an hour on a chair (or wheelchair) without cardiac, respiratory disturbances and/or pain. Exclusion Criteria: Inability to understand and/or follow instructions Pain in shoulder or arm Other neurological or musculoskeletal target organ disorder Inability to give informed consent personally Previous or current contracture of the upper extremity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Krakauer, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia Univeristy, Neurological Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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Effect of Robot Rehabilitation Exercise Training on Motor Control After Stroke

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