Skip to main content
Clinical Trials/NCT00765544
NCT00765544
Terminated
Phase 1

Robot-assisted Ankle Rehabilitation for Multiple Sclerosis (Anklebot)

US Department of Veterans Affairs1 site in 1 country10 target enrollmentSeptember 2008

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
US Department of Veterans Affairs
Enrollment
10
Locations
1
Primary Endpoint
Strength and Gait
Status
Terminated
Last Updated
12 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
September 2008
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Strength and Gait

Time Frame: 6 months

Study Sites (1)

Loading locations...

Similar Trials