Status:
COMPLETED
Effect of Robot-assisted Training on Foot Drop in Multiple Sclerosis
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
MS (Multiple Sclerosis)
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The primary aim of this study is to: 1. Collect pilot data on the effect of task-specific lower extremity training using the Anklebot on subjects with Multiple Sclerosis (MS) and who have foot drop; ...
Eligibility Criteria
Inclusion
- Clinical diagnosis of MS by McDonald criteria (McDonald, Compston et al. 2001). EDSS level between 3.5-5.5, who report ambulation problems.
- Presence of unilateral foot drop that is clinically apparent to the PI or PI designate.
- Must be able to ambulate 25 feet without an assisting device.
Exclusion
- Cardiovascular: recent MI \< 4 wk, uncontrolled HTN \>190/110 mmHg.
- History of uncontrolled diabetes.
- Symptoms of orthostasis when standing up.
- Circulatory problems, history of vascular claudication or pitting edema.
- Unable to fully understand instructions in order to use the equipment or the process of the study.
- Body weight over 150 kg.
- Lower extremity injuries that limit range of motion or function.
- Joint problems (hip or leg) that limit range of motion or cause pain with movement despite treatment.
- Unstable fractures.
- Pressure sores with any skin breakdown in areas in contact with the body harness or Lokomat apparatus.
- Chronic and ongoing alcohol or drug abuse.
- Pre-morbid, ongoing depression or psychosis.
- Ongoing physical therapy.
- Pregnancy (self-reported)
- PI's determination of inability to complete the test protocol
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00872053
Start Date
February 1 2009
End Date
January 1 2010
Last Update
September 20 2013
Active Locations (1)
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1
Providence VA Medical Center
Providence, Rhode Island, United States, 02908-4799