Lokomat Treadmill Training Effects on MS Gait

Multiple Sclerosis Clinical Trial

Official title:

Lokomat Treadmill Training Effects on MS Gait

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00835835
• Other study ID #: AL0001
• Status: Completed
• Phase: N/A
• First received: February 3, 2009
• Last updated: November 9, 2015
• Start date: February 2008
• Est. completion date: June 2013

Study information

• Verified date: November 2015
• Source: Mount Sinai Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 2013
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gait, Unsteady
• Multiple Sclerosis

Intervention

Other:
• Body-weight supported treadmill training +/- Lokomat assistance
walking
• Usual Care - no active intervention
No treatment used for comparison

Locations

Country	Name	City	State
United States	Mandell Center for Multiple Sclerosis at Mt. Sinai Rehabilitation Hospital	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Mount Sinai Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

References & Publications (4)

Duncan PW, Weiner DK, Chandler J, Studenski S. Functional reach: a new clinical measure of balance. J Gerontol. 1990 Nov;45(6):M192-7. — View 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. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Other	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	No
Other	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	Yes
Other	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	No
Other	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	Yes
Other	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	Yes
Primary	Gait Parameters		Baseline, throughout study enrollment and 2 months follow-up	Yes