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

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 Overview

• Status: Completed
• Conditions: MS (Multiple Sclerosis)
• Intervention / Treatment: Device: Anklebot; Device: Lokomat

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02908-4799
      • Providence VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ankle accuracy and stiffness	At inclusion, after 8 sessions, after 16 sessions

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: US Department of Veterans Affairs

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (ACTUAL): December 1, 2009
• Study Completion (ACTUAL): January 1, 2010

Study Registration Dates

• First Submitted: March 27, 2009
• First Submitted That Met QC Criteria: March 27, 2009
• First Posted (ESTIMATE): March 31, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): September 20, 2013
• Last Update Submitted That Met QC Criteria: September 18, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: gait; rehabilitation; robot; treadmill; foot drop
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Multiple Sclerosis; Sclerosis; Peroneal Neuropathies
• Other Study ID Numbers: B4125K-1