Lokomat Treadmill Training Effects on MS Gait

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jennifer Fawcett, Mount Sinai Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT00835835
First received: February 3, 2009
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

This study is being done to test the possible benefits of gait-specific training using body-weight supported, Lokomat assisted, treadmill training in people with Multiple Sclerosis.


Condition Intervention
Gait, Unsteady
Multiple Sclerosis
Other: Body-weight supported treadmill training +/- Lokomat assistance

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lokomat Treadmill Training Effects on MS Gait

Resource links provided by NLM:


Further study details as provided by Mount Sinai Rehabilitation Hospital:

Primary Outcome Measures:
  • Gait Parameters [ Time Frame: Baseline, throughout study enrollment and 2 months follow-up ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • 6 minute walk [ Time Frame: Baseline, throughout study enrollment and 2 months follow-up ] [ Designated as safety issue: Yes ]
    The 6 minute walk test is measured on a treadmill. The subject is asked to indicate the most comfortable treadmill speed to the therapist. The subject is instructed to walk as far as possible in 6 minutes and the total distance covered in 6 minutes is recorded. A harness, without body-weight support, is attached for safety.

  • MSQLI (Multiple Sclerosis Quality of Life Index) [ Time Frame: Baseline, throughout study enrollment and 2 months follow-up ] [ Designated as safety issue: No ]
    The MSQLI is a battery consisting of 10 individual scales providing a quality of life measure that is both generic and MS-specific (Fischer et al, 1999). The MS quality of life index is a validated instrument used in accessing multiple aspects of quality of life for persons with MS. It is a modification of the short-form health survey (SF-36) and requires about 30-45 minutes to complete.

  • Timed 25-foot walk [ Time Frame: Baseline, throughout study enrollment and 2 months follow-up ] [ Designated as safety issue: Yes ]
    Will be collected over-ground and on a straight 25-foot GaitRite electronic mat. The subject will be timed over the 25-foot distance both at their self-designated usual pace and at the fastest safe pace possible. Data will be collected using a laptop computer. The GaitRite system has software to calculate several measures including velocity, stride length, base width and number of steps.

  • Frequency of Falls [ Time Frame: Baseline, throughout study enrollment and 2 months follow-up ] [ Designated as safety issue: No ]
    Falls will be recorded by the subjects onto a "Falls Calender" provided to the subjects. Subjects will be given the following definition of a fall: "an event which results in a person coming to rest inadvertently on the ground or other lower level, and other than as a consequence of the following: sustaining a violent blow; loss of consciousness; sudden onset of paralysis, as in a stroke and an epileptic seizure" (Vellas 1992).

  • FRT (Functional Reach Test) [ Time Frame: Baseline, throughout study enrollment and 2 months follow-up ] [ Designated as safety issue: Yes ]
    The Functional Reach test is a measure of balance and is the difference from arm's length and maximal forward reach. The support case is fixed. The test utilizes a 48-inch measuring device or "yardstick" for measuring functional reach. Data is measured in inches (Duncan P. W. et al 1990).

  • CDP (Computerized Dynamic Posturography) [ Time Frame: Baseline, throughout study enrollment and 2 months follow-up ] [ Designated as safety issue: Yes ]

    NeuroCom Smart Balance Master system. The use of CDP has allowed clinicians to objectively measure the postural components of balance (Liston 1996). CDP assesses sway by measuring shifts in the center of gravity (COG) as a person moves within the available limits of stability (LOS). Two types of tests will be used with CDP; they are the Sensory Organization Test (SOT) and the LOS test.

    1. SOT: measures sway and is designed to quantify an individual's ability to maintain balance in a variety of complex sensory conditions.
    2. LOS: measures volitional control of the COG. Test measures include maximum end-point excursion for anterior, posterior, right, and left movements.


Enrollment: 8
Study Start Date: February 2008
Study Completion Date: June 2013
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control group
The placebo group did not receive treatment during the matched period yet did undergo all assessments. The MS Placebo group received equal treatment following the study intervention period.
Experimental: Combination Treadmill training group
Subjects randomized to Combination therapy received 20 minutes of Lokomat assisted treadmill training followed by up to 20 minutes of BWS treadmill training (without robotic assistance) twice a week.
Other: Body-weight supported treadmill training +/- Lokomat assistance
walking
Other Name: Lokomat

  Eligibility

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Clinical diagnosis of MS
  • EDSS level between 3.5-6.0
  • Problems with ambulation
  • able to ambulate 25 feet without an assistive device

Main Exclusion Criteria:

  • Lower extremity injuries that limit range of motion or function
  • Unable to demonstrate an understanding of the process of the study and or fully understand instructions in order to safely participate in the study and use study equipment
  • Body weight over 150 kg

    • complete inclusion/exclusion criteria listed in consent form
  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: NCT00835835

Locations
United States, Connecticut
Mandell Center for Multiple Sclerosis at Mt. Sinai Rehabilitation Hospital
Hartford, Connecticut, United States, 06112
Sponsors and Collaborators
Mount Sinai Rehabilitation Hospital
Investigators
Principal Investigator: Albert Lo, MD, PhD Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital
  More Information

Publications:
Responsible Party: Jennifer Fawcett, Research Manager, Mount Sinai Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT00835835     History of Changes
Other Study ID Numbers: AL0001
Study First Received: February 3, 2009
Last Updated: April 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai Rehabilitation Hospital:
Multiple Sclerosis
gait
falls
lokomat
body-weight support treadmill training

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Gait Disorders, Neurologic
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014