Clinical trial NCT00835835: Lokomat Treadmill Training Effects on MS Gait
Official title: Lokomat Treadmill Training Effects on MS Gait
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gait, Unsteady
Multiple Sclerosis
Keywords: Multiple Sclerosis
gait
falls
lokomat
body-weight support treadmill training
Lead sponsor: Mount Sinai Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2009-02-04
Enrollment: 8
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Gait Parameters
timeFrame: Baseline, throughout study enrollment and 2 months follow-up
Secondary outcomes:
Other outcomes:
measure: 6 minute walk
timeFrame: Baseline, throughout study enrollment and 2 months follow-up
measure: MSQLI (Multiple Sclerosis Quality of Life Index)
timeFrame: Baseline, throughout study enrollment and 2 months follow-up
measure: Timed 25-foot walk
timeFrame: Baseline, throughout study enrollment and 2 months follow-up
measure: Frequency of Falls
timeFrame: Baseline, throughout study enrollment and 2 months follow-up
measure: FRT (Functional Reach Test)
timeFrame: Baseline, throughout study enrollment and 2 months follow-up
measure: CDP (Computerized Dynamic Posturography)
timeFrame: Baseline, throughout study enrollment and 2 months follow-up
Locations:
city: Hartford
country: United States
facility: Mandell Center for Multiple Sclerosis at Mt. Sinai Rehabilitation Hospital
state: Connecticut
Study officials:
affiliation: Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital
name: Albert Lo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fischer JS, LaRocca NG, Miller DM, Ritvo PG, Andrews H, Paty D. Recent developments in the assessment of quality of life in multiple sclerosis (MS). Mult Scler. 1999 Aug;5(4):251-9. doi: 10.1177/135245859900500410.
citation: Vellas B, Baumgartner RN, Wayne SJ, Conceicao J, Lafont C, Albarede JL, Garry PJ. Relationship between malnutrition and falls in the elderly. Nutrition. 1992 Mar-Apr;8(2):105-8.
citation: Duncan PW, Weiner DK, Chandler J, Studenski S. Functional reach: a new clinical measure of balance. J Gerontol. 1990 Nov;45(6):M192-7. doi: 10.1093/geronj/45.6.m192.
citation: Liston RA, Brouwer BJ. Reliability and validity of measures obtained from stroke patients using the Balance Master. Arch Phys Med Rehabil. 1996 May;77(5):425-30. doi: 10.1016/s0003-9993(96)90028-3.