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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Gait, Unsteady
• Intervention / Treatment: Other: Usual Care - no active intervention; Other: Body-weight supported treadmill training +/- Lokomat assistance

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06112
      • Mandell Center for Multiple Sclerosis at Mt. Sinai Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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; walking; Other Names: Lokomat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Gait Parameters	Baseline, throughout study enrollment and 2 months follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 minute walk	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.	Baseline, throughout study enrollment and 2 months follow-up
MSQLI (Multiple Sclerosis Quality of Life Index)	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.	Baseline, throughout study enrollment and 2 months follow-up
Timed 25-foot walk	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.	Baseline, throughout study enrollment and 2 months follow-up
Frequency of Falls	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).	Baseline, throughout study enrollment and 2 months follow-up
FRT (Functional Reach Test)	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).	Baseline, throughout study enrollment and 2 months follow-up
CDP (Computerized Dynamic Posturography)	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.	Baseline, throughout study enrollment and 2 months follow-up

Collaborators and Investigators

• Sponsor: Mount Sinai Rehabilitation Hospital
• Investigators: Principal Investigator: Albert Lo, MD, PhD, Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• Mandell Center for Multiple Sclerosis home page

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: February 3, 2009
• First Submitted That Met QC Criteria: February 3, 2009
• First Posted (Estimate): February 4, 2009

Study Record Updates

• Last Update Posted (Estimate): November 11, 2015
• Last Update Submitted That Met QC Criteria: November 9, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; gait; falls; lokomat; body-weight support treadmill training
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neurologic Manifestations; Multiple Sclerosis; Sclerosis; Gait Disorders, Neurologic
• Other Study ID Numbers: AL0001