Effect of Robot-assisted Training on Foot Drop in Multiple Sclerosis

Completed · Phase 1/Phase 2

Conditions studied: MS (Multiple Sclerosis)

In brief

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; 2. Collect pilot data on the use of combination therapy on improving gait in subjects with MS. This therapy will use both Anklebot training and robot-assisted gait training. Hypothesis: Both trainings will result in improved walking performance, but the combination therapy will result in greater gains than ankle training alone.

Key facts

Study ID

NCT00872053

Run by

US Department of Veterans Affairs

People needed

18

Starts

2009-02-01

Expected to finish

2010-01-01

Last updated by the study team

2013-09-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Providence VA Medical Center — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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