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

Phase 2CompletedNCT00872053

US Department of Veterans Affairs18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

MS (Multiple Sclerosis)

Interventions

AnklebotDEVICE

The Anklebot is a robotic device that is worn via a leather boot and knee brace (Fig.1). As the participant goes through a series of ankle-training "games," the Anklebot can assist ankle movement throughout 3 planes.

LokomatDEVICE

The Lokomat is a motor driven exoskeleton device that employs a body weight support suspension system and treadmill. Attached to the lower limbs, the Lokomat moves the subject's legs over a treadmill through position controlled trajectories that mimic normal human gait patterns.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Providence VA Medical Center

Providence, Rhode Island, United States

Outcomes

Primary Outcomes

Ankle accuracy and stiffness

Time frame: At inclusion, after 8 sessions, after 16 sessions

Secondary Outcomes

Gait assessments (e.g., 6-Minute Walk, Timed 25-Foot Walk)

Time frame: At inclusion, after every 4 sessions

Functional assessments (EDSS, MS Functional Composite)

Time frame: At inclusion, after 8 sessions, after 16 sessions

Data from ClinicalTrials.gov

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