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

Sponsor

US Department of Veterans Affairs (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00872053

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary aim of this study is to:

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;
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.

Condition or Disease	Intervention/Treatment	Phase
MS (Multiple Sclerosis)	Device: Anklebot Device: Lokomat	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 Focused Ankle Training	Device: Anklebot 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.
Experimental: Arm 2 Combination Therapy	Device: Anklebot 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. Device: Lokomat 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.

Arm

Intervention/Treatment

Experimental: Arm 1

Focused Ankle Training

Device: Anklebot

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.

Experimental: Arm 2

Combination Therapy

Device: Anklebot

Device: Lokomat

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.

Outcome Measures

Primary Outcome Measures

Ankle accuracy and stiffness [At inclusion, after 8 sessions, after 16 sessions]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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