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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00872053
First received: March 27, 2009
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
MS (Multiple Sclerosis)
Device: Anklebot
Device: Lokomat
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Robot-assisted Training on Foot Drop in Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Ankle accuracy and stiffness [ Time Frame: At inclusion, after 8 sessions, after 16 sessions ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gait assessments (e.g., 6-Minute Walk, Timed 25-Foot Walk) [ Time Frame: At inclusion, after every 4 sessions ] [ Designated as safety issue: No ]
  • Functional assessments (EDSS, MS Functional Composite) [ Time Frame: At inclusion, after 8 sessions, after 16 sessions ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: February 2009
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00872053

Locations
United States, Rhode Island
Providence VA Medical Center
Providence, Rhode Island, United States, 02908-4799
Sponsors and Collaborators
Investigators
Principal Investigator: Albert Lo, MD PhD Providence VA Medical Center
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00872053     History of Changes
Other Study ID Numbers: B4125K-1
Study First Received: March 27, 2009
Last Updated: September 18, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
robot
treadmill
foot drop
rehabilitation
gait

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 26, 2014