Effect of Robot-assisted Training on Foot Drop in Multiple Sclerosis

US Department of Veterans Affairs (VA)

Status and phase: Completed; Phase 2; Phase 1

Conditions: MS (Multiple Sclerosis)

Treatments: Device: Anklebot; Device: Lokomat

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00872053

B4125K-1

Details and patient eligibility

About

The primary aim of this study is to:

1. Collect pilot data on the effect of task-specific lower extremity training using the Anklebot on subjects with Multiple Sclerosis (MS) and who have foot drop;
2. Collect pilot data on the use of combination therapy on improving gait in subjects with MS. This therapy will use both Anklebot training and robot-assisted gait training.

Hypothesis: Both trainings will result in improved walking performance, but the combination therapy will result in greater gains than ankle training alone.

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.
• 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.
• Pregnancy (self-reported)
• PI's determination of inability to complete the test protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 2 patient groups

Arm 1

Experimental group

Description:

Focused Ankle Training

Treatment:

Device: Anklebot

Arm 2

Experimental group

Description:

Combination Therapy

Treatment:

Device: Lokomat

Device: Anklebot