Targeted Lower Extremity Joint Training

Multiple Sclerosis Clinical Trial

Official title:

Robot-assisted Ankle Rehabilitation for Multiple Sclerosis (Anklebot)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00765544
• Other study ID #: LO-0002
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: October 2, 2008
• Last updated: September 19, 2013
• Start date: September 2008
• Est. completion date: September 2008

Study information

• Verified date: September 2013
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• Anklebot
The Ankle-Bot (Wheeler et al., 2004) is a stand-alone robot assisted device that is worn via a leather boot and knee brace (Fig.1). The Ankle-Bot can assist ankle movement throughout 3 planes. The percentage of force generated by the Ankle-Bot can be adjusted from no help, 0% assistance to 100% assistance. The device is low impedance and a subject can easily over come the forces generated by the Ankle-Bot. The Ankle-Bot will guide and assist the subject into ankle flexion, extension, inversion and eversion.
• Lokomat
The Lokomat is a motor driven exoskeleton device that employs a body weight support suspension system and treadmill .

Locations

Country	Name	City	State
United States	Providence VA Medical Center	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Strength and Gait		6 months	No