Gait, Unsteady, Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, gait, falls, lokomat, body-weight support treadmill training
Brief summary
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.
Interventions
OTHERBody-weight supported treadmill training +/- Lokomat assistance
walking
OTHERUsual Care - no active intervention
No treatment used for comparison
Sponsors
Mount Sinai Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gait Parameters | Baseline, throughout study enrollment and 2 months follow-up |
Other
| Measure | Time frame | Description |
|---|---|---|
| MSQLI (Multiple Sclerosis Quality of Life Index) | Baseline, throughout study enrollment and 2 months follow-up | 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 | Baseline, throughout study enrollment and 2 months follow-up | 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. |
| 6 minute walk | Baseline, throughout study enrollment and 2 months follow-up | 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. |
| FRT (Functional Reach Test) | Baseline, throughout study enrollment and 2 months follow-up | 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) | Baseline, throughout study enrollment and 2 months follow-up | 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. |
| Frequency of Falls | Baseline, throughout study enrollment and 2 months follow-up | 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). |
Countries
United States
Outcome results
None listed