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Completed

NCT Number: NCT00835835

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.

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Key information

Conditions

Gait, Unsteady Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Gait Disorders, Neurologic Immune System Diseases Multiple Sclerosis Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mandell Center for Multiple Sclerosis at Mt. Sinai Rehabilitation Hospital

Hartford, Connecticut, 06112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Body-weight supported treadmill training +/- Lokomat assistance

Other

walking

Other names: Lokomat

Usual Care - no active intervention

Other

No treatment used for comparison

Other names: control group

Primary outcomes

  1. Gait Parameters

    Time frame: Baseline, throughout study enrollment and 2 months follow-up

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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).

  6. 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.

Sponsors and collaborators

Lead sponsor

Mount Sinai Rehabilitation Hospital

Other

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2013
First posted
Feb 4, 2009
Registry last updated
Nov 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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