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Shoulder, or Elbow, or Wrist: What Should we Train First After a Stroke?

Primary Purpose

Stroke

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
rehabilitation robotics
Movement therapy
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, movement therapy, robotics, rehabilitation robotics, shoulder, elbow, wrist

Eligibility Criteria

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

Inclusion Criteria:

Patients will be included in the study if they meet the following criteria:

  1. naïve subjects who have never experienced robot-assisted therapy as inpatients or outpatients;
  2. first single focal unilateral lesion with diagnosis verified by brain imaging (MRI or CT scans) that has occurred at least 6 months prior;
  3. cognitive function sufficient to understand the experiments and follow instructions (Mini-Mental Status Score of 22 and higher or interview for aphasic subjects);
  4. average Motor Power score >= 1/5 or <= 3/5 (neither hemiplegic nor fully recovered motor function in 6 muscles of the shoulder, elbow, and wrist);
  5. informed written consent to participate in the study.

Exclusion Criteria:

Patients will be excluded from the study if they have a fixed contraction deformity in the affected limb.

Sites / Locations

  • Burke Medical Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

proximal to distal training

distal to proximal

proximal and distal on alternate days

proximal and distal same day

Arm Description

Outcomes

Primary Outcome Measures

Fugl-Meyer
Motor Power

Secondary Outcome Measures

Wolf Motor Function
SIS

Full Information

First Posted
March 27, 2007
Last Updated
October 28, 2012
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
Burke Medical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00453843
Brief Title
Shoulder, or Elbow, or Wrist: What Should we Train First After a Stroke?
Official Title
The Effect of Proximal and Distal Training on Stroke Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
Burke Medical Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
We will test on persons with chronic impairment due to stroke: whether the order in which robot therapy is delivered influences outcomes (shoulder-and-elbow before wrist vs. wrist before shoulder-and-elbow). whether we should train the shoulder, elbow, and wrist at the same time or on different days.
Detailed Description
The Effect of Proximal and Distal Training on Stroke Recovery: Specific Aim 1. Test whether task specific wrist robotic training improves motor performance among persons with chronic impairment after stroke. Specific Aim 2. Test whether the order in which robot therapy is delivered influences outcomes (shoulder-and-elbow before wrist vs. wrist before shoulder-and-elbow). Specific Aim 3. Test whether there is generalization across different joints (shoulder & elbow vs wrist). Specific Aim 4: Test whether there is any interference between training across different joints among persons with chronic impairment after stroke. Briefly we will invite persons with chronic impairment due to stroke to participate in a study that will train them first on wrist for 6 weeks and then on the shoulder-and-elbow for an additional 6 weeks or vice-versa. A third group will train in alternate days for 12 weeks on the shoulder-and-elbow or the wrist, while a fourth group will be trained on the shoulder, elbow, and wrist on the same day. Outcomes will be measured using standard instruments as well as robot-based measures. We expect that results from this study will provide an objective basis for maximizing this kind of therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, movement therapy, robotics, rehabilitation robotics, shoulder, elbow, wrist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
proximal to distal training
Arm Type
Experimental
Arm Title
distal to proximal
Arm Type
Experimental
Arm Title
proximal and distal on alternate days
Arm Type
Experimental
Arm Title
proximal and distal same day
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
rehabilitation robotics
Other Intervention Name(s)
InMotion2.0 (InMotion Arm) and InMotion3.0 (InMotion Wrist)
Intervention Description
sequence of intervention
Intervention Type
Procedure
Intervention Name(s)
Movement therapy
Other Intervention Name(s)
InMotion2.0 (InMotion Arm) and InMotion3.0 (InMotion Wrist)
Intervention Description
sequence of intervention
Primary Outcome Measure Information:
Title
Fugl-Meyer
Time Frame
3 times at baseline, midpoint, completion intervention, and at follow-up
Title
Motor Power
Time Frame
3 times at baseline, midpoint, completion intervention, and at follow-up
Secondary Outcome Measure Information:
Title
Wolf Motor Function
Time Frame
3 times at baseline, midpoint, completion intervention, and at follow-up
Title
SIS
Time Frame
3 times at baseline, midpoint, completion intervention, and at follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients will be included in the study if they meet the following criteria: naïve subjects who have never experienced robot-assisted therapy as inpatients or outpatients; first single focal unilateral lesion with diagnosis verified by brain imaging (MRI or CT scans) that has occurred at least 6 months prior; cognitive function sufficient to understand the experiments and follow instructions (Mini-Mental Status Score of 22 and higher or interview for aphasic subjects); average Motor Power score >= 1/5 or <= 3/5 (neither hemiplegic nor fully recovered motor function in 6 muscles of the shoulder, elbow, and wrist); informed written consent to participate in the study. Exclusion Criteria: Patients will be excluded from the study if they have a fixed contraction deformity in the affected limb.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hermano I Krebs, PhD
Organizational Affiliation
Massachusetts Institute of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Burke Medical Research Institute
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States

12. IPD Sharing Statement

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Shoulder, or Elbow, or Wrist: What Should we Train First After a Stroke?

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