Lokomat Treadmill Training Effects on MS Gait
|ClinicalTrials.gov Identifier: NCT00835835|
Recruitment Status : Completed
First Posted : February 4, 2009
Last Update Posted : November 11, 2015
|Condition or disease||Intervention/treatment||Phase|
|Gait, Unsteady Multiple Sclerosis||Other: Body-weight supported treadmill training +/- Lokomat assistance Other: Usual Care - no active intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Lokomat Treadmill Training Effects on MS Gait|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||June 2013|
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.
Other: Usual Care - no active intervention
No treatment used for comparison
Other Name: control group
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
Other Name: Lokomat
- Gait Parameters [ Time Frame: Baseline, throughout study enrollment and 2 months follow-up ]
- 6 minute walk [ Time Frame: 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.
- MSQLI (Multiple Sclerosis Quality of Life Index) [ Time Frame: 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 [ Time Frame: 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.
- Frequency of Falls [ Time Frame: 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).
- FRT (Functional Reach Test) [ Time Frame: 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) [ Time Frame: 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.
- SOT: measures sway and is designed to quantify an individual's ability to maintain balance in a variety of complex sensory conditions.
- LOS: measures volitional control of the COG. Test measures include maximum end-point excursion for anterior, posterior, right, and left movements.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00835835
|United States, Connecticut|
|Mandell Center for Multiple Sclerosis at Mt. Sinai Rehabilitation Hospital|
|Hartford, Connecticut, United States, 06112|
|Principal Investigator:||Albert Lo, MD, PhD||Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital|