Lokomat Treadmill Training Effects on MS Gait

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Claire Koenig, Mount Sinai Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT00835835
First received: February 3, 2009
Last updated: May 10, 2013
Last verified: May 2013

February 3, 2009
May 10, 2013
February 2008
October 2011   (final data collection date for primary outcome measure)
Gait Parameters [ Time Frame: Baseline, throughout study enrollment and 2 months follow-up ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00835835 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
  • 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.
Not Provided
 
Lokomat Treadmill Training Effects on MS Gait
Lokomat Treadmill Training Effects on MS Gait

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
  • Gait Abnormalities
  • Multiple Sclerosis
Device: Body-weight supported treadmill training +/- Lokomat assistance
walking
Other Name: Lokomat
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
15
June 2013
October 2011   (final data collection date for primary outcome measure)

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
Both
25 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00835835
AL0001
Not Provided
Claire Koenig, Mount Sinai Rehabilitation Hospital
Mount Sinai Rehabilitation Hospital
Not Provided
Principal Investigator: Albert Lo, MD, PhD Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital
Mount Sinai Rehabilitation Hospital
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP