Targeted Lower Extremity Joint Training
Stopped early · Phase 1/Phase 2
Conditions studied: Multiple Sclerosis
In brief
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.
Key facts
- Study ID
- NCT00765544
- Run by
- US Department of Veterans Affairs
- People needed
- 10
- Starts
- 2008-09-01
- Expected to finish
- 2008-09-01
- Last updated by the study team
- 2013-09-23
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.
- Men and women between the ages 18-75 years.
- 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.
Where it is running
- Providence VA Medical Center — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
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