Stopped earlyPhase 1Phase 2MS (type not specified)NCT00765544

What it found

Stopped early

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

    1. Started

      Sept 2008

    2. Main results due

      Sept 2008

    3. Finished

      Sept 2008

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