Multiple Sclerosis Clinical Trial

Targeted Lower Extremity Joint Training

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

10

Study ID:

NCT00765544

Recruitment Status:

Terminated

Sponsor:

US Department of Veterans Affairs

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Providence VA Medical Center
Providence Rhode Island, 02908, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

10

Study ID:

NCT00765544

Recruitment Status:

Terminated

Sponsor:


US Department of Veterans Affairs

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider