Targeted Lower Extremity Joint Training

US Department of Veterans Affairs (VA)

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Multiple Sclerosis

Treatments: Device: Lokomat; Device: Anklebot

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00765544

LO-0002

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 3 patient groups

Arm 1

Experimental group

Description:

Anklebot

Treatment:

Device: Anklebot

Arm 2

Experimental group

Description:

Body-weight supported treadmill training

Treatment:

Device: Lokomat

Arm 3

Experimental group

Description:

Combination therapy (Anklebot and BWSTT)

Treatment:

Device: Lokomat

Device: Anklebot