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

NCT ID: NCT00872053

Last Updated: 2013-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2010-01-31

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.

Conditions

MS (Multiple Sclerosis)

Keywords

robot; treadmill; foot drop; rehabilitation; gait

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm 1

Focused Ankle Training

Group Type: EXPERIMENTAL

Anklebot

Intervention Type: DEVICE

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.

Arm 2

Combination Therapy

Group Type: EXPERIMENTAL

Anklebot

Intervention Type: DEVICE

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.

Lokomat

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Albert Lo, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Providence VA Medical Center

Locations

Providence VA Medical Center

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

B4125K-1

Identifier Type: -

Identifier Source: org_study_id