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

Phase 1

Completed

• Conditions: MS (Multiple Sclerosis)
• Interventions: Device: Anklebot; Device: Lokomat

• Registration Number: NCT00872053
• Lead Sponsor: US Department of Veterans Affairs

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-03-27
• Study First Submitted QC: 2009-03-27
• Study First Posted: 2009-03-31
• Primary Completion: 2009-12
• Study Completion: 2010-01
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-18
• Last Update Posted: 2013-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Anklebot	Focused Ankle Training
Arm 2	Anklebot	Combination Therapy
Arm 2	Lokomat	Combination Therapy

Primary Outcome Measures

Name	Time	Method
Ankle accuracy and stiffness	At inclusion, after 8 sessions, after 16 sessions

Secondary Outcome Measures

Name	Time	Method
Gait assessments (e.g., 6-Minute Walk, Timed 25-Foot Walk)	At inclusion, after every 4 sessions
Functional assessments (EDSS, MS Functional Composite)	At inclusion, after 8 sessions, after 16 sessions

Trial Locations

Locations (1)

Providence VA Medical Center; 🇺🇸 Providence, Rhode Island, United States