Robot-Assisted Motivating Rehabilitation
1 other identifier
interventional
24
1 country
1
Brief Summary
The purpose of the study is to examine how a novel robot technology designed for eventual use as a home therapy can improve arm function after stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 stroke
Started Jul 2006
Longer than P75 for phase_1 stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 30, 2006
CompletedFirst Posted
Study publicly available on registry
October 31, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFebruary 4, 2014
February 1, 2014
6.9 years
October 30, 2006
February 3, 2014
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Subjects will be included in the study on the basis of the following criteria:
- They must be at least six months post-stroke.
- years of age or older with a clinical diagnosis of hemiparesis (as verified by medical record and a medical expert).
- They have voluntary control with a low to medium range of motion function (UE-FT\<5) and a muscle tone.
- They are functionally stable (no significant changes in motor function over a week) and are able to tolerate being seated upright for 90 minutes.
- They report no excessive pain the impaired arm.
- If left neglect or spasticity is detected in the impaired arm, these levels must not interfere with the ability to cognitively complete the tasks or turn a wheel.
- They must not be participating in any experimental rehabilitation or drug therapies.
- If subjects are receiving chemical injections for spasticity, they must be at least 3-months away from their last treatment.
- They must have driven prior to stroke.
- They are not clinically depressed (as measured by the Geriatric Depression Scale (GDS) short form (Sheikh and Yesavage, 1986).
You may not qualify if:
- Once informed consent is given twenty-four of these subjects will be randomized into two training groups (fun driving: fun and functional driving activities and rote tracking (12 subjects): rote and functional tracking activities). Two subjects will be randomized the case study group. The groups will be matched in initial motor function.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical College of Wisconsinlead
- American Heart Associationcollaborator
Study Sites (1)
Clement J Zablocki VA - Rehabilitation Robotics R&D Lab
Milwaukee, Wisconsin, 53295, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle J Johnson, PhD
Medical College of Wisconsin
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Adjunct Associate Professor
Study Record Dates
First Submitted
October 30, 2006
First Posted
October 31, 2006
Study Start
July 1, 2006
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
February 4, 2014
Record last verified: 2014-02