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

Primary Purpose

MS (Multiple Sclerosis)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Anklebot
Lokomat
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for MS (Multiple Sclerosis) focused on measuring robot, treadmill, foot drop, rehabilitation, gait

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Providence VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

Focused Ankle Training

Combination Therapy

Outcomes

Primary Outcome Measures

Ankle accuracy and stiffness

Secondary Outcome Measures

Gait assessments (e.g., 6-Minute Walk, Timed 25-Foot Walk)
Functional assessments (EDSS, MS Functional Composite)

Full Information

First Posted
March 27, 2009
Last Updated
September 18, 2013
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00872053
Brief Title
Effect of Robot-assisted Training on Foot Drop in Multiple Sclerosis
Official Title
Effect of Robot-assisted Training on Foot Drop in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MS (Multiple Sclerosis)
Keywords
robot, treadmill, foot drop, rehabilitation, gait

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Focused Ankle Training
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Combination Therapy
Intervention Type
Device
Intervention Name(s)
Anklebot
Intervention Description
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
Intervention Name(s)
Lokomat
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ankle accuracy and stiffness
Time Frame
At inclusion, after 8 sessions, after 16 sessions
Secondary Outcome Measure Information:
Title
Gait assessments (e.g., 6-Minute Walk, Timed 25-Foot Walk)
Time Frame
At inclusion, after every 4 sessions
Title
Functional assessments (EDSS, MS Functional Composite)
Time Frame
At inclusion, after 8 sessions, after 16 sessions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Lo, MD PhD
Organizational Affiliation
Providence VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence VA Medical Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908-4799
Country
United States

12. IPD Sharing Statement

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

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