Targeted Lower Extremity Joint Training
What it found
The trial ended early for another reason (see below).
Reason given: Study re-design
This trial finished 18 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Anklebot
- Lokomat
What it measured
Main measures
Strength and Gait
6 months
Walking and mobilityPhysical function
Who could take part
MS (type not specified) · 18 to 75
Inclusion Criteria: 1. Clinical diagnosis of MS by McDonald criteria (McDonald, Compston et al. 2001). EDSS level between 3.5-5.5, who report ambulation problems. 2. Men and women between the ages 18-75 years. 3. Presence of unilateral foot drop that is clinically apparent to the PI or PI designate. 4. Must be able to ambulate 25 feet without an assisting device Exclusion Criteria: 1. Cardiovascular: recent MI \< 4 wk, uncontrolled HTN >190/110 mmHg, History of uncontrolled diabetes. 2. Symptoms of orthostasis when standing up. 3. Circulatory problems, history of vascular claudication or pitting edema. 4. Unable to fully understand instructions in order to use the equipment or the process of the study. 5. Body weight over 150 kg. 6. Lower extremity injuries that limit range of motion or function. 7. Joint problems (hip or leg) that limit range of motion or cause pain with movement despite treatment. 8. Unstable fractures. 9. Pressure sores with any skin breakdown in areas in contact with the body harness or Lokomat apparatus. 10. Chronic and ongoing alcohol or drug abuse. 11. Pre-morbid, ongoing depression or psychosis. 12. Ongoing physical therapy.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The presence of foot drop limits normal gait. Our prior data has suggested that approximately 30% of MS patients have foot drop. Although we have observed that "task-specific" rehabilitation using the Lokomat can improve ambulation in chronic MS patients, subjects with "foot drop" have difficulty translating task-specific training to normative gait patterns over ground, despite improving speed and endurance. One of the key limitations of the Lokomat is a lack of robot-assisted training for the ankle joint. The Anklebot, an MIT-developed rehabilitation robot for the ankle, has the potential to address this. The device can move throughout three planes and train ankle flexion, extension, inversion and eversion; however, therapy with the Anklebot alone does not train the knee or hip. We plan to test whether subject foot drop and overall gait benefit more from Anklebot therapy alone or a combination of Anklebot and Lokomat.
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History
Started
Sept 2008
Main results due
Sept 2008
Finished
Sept 2008
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