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NCT Number: NCT01992679

Body Weight Supported Treadmill Training in Persons With Multiple Sclerosis

There is growing evidence that exercise-based rehabilitation results in improvements in mobility and participation in persons with multiple sclerosis (MS). However, the vast majority of the scientific evidence in support of this view is based on persons with MS who have minimal mobility impairment. This is partially due to the lack of accessible exercise equipment and facilities available to persons with severe mobility limitations.

One option available to persons with severe mobility limitations is body weight supported treadmill training. Indeed, this rehabilitation approach has been utilized with some success in various clinical populations, such as stroke and spinal cord injury, and is believed to target neuroplasticity. Specific to persons with MS, body weight supported treadmill training has shown great promise in improving quality of life, symptoms and functional mobility in two small (n=4 and n=6) pilot investigations. However, previous research has been hampered by methodological limitations including small sample size, lack of a control group and limited training sessions. Consequently, no firm conclusion regarding the benefit of body weighted supported treadmill training in persons with MS can be drawn. The proposed project seeks to determine if twenty-weeks of body weight supported treadmill training leads to improvements in physiological function, mobility and quality of life in persons with MS with severe mobility limitations. The outcomes of this project have the potential to lead to new rehabilitation approaches capable of improving function and quality of life in persons with advanced MS.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Illinois UC

Urbana-Champaign, Illinois, 61801, United States

About this study

One option available to persons with severe mobility limitations is body weight supported treadmill training. Indeed, this rehabilitation approach has been utilized with some success in various clinical populations, such as stroke and spinal cord injury, and is believed to target neuroplasticity. Specific to persons with MS, body weight supported treadmill training has shown great promise in improving quality of life, symptoms and functional mobility in two small (n=4 and n=6) pilot investigations. However, previous research has been hampered by methodological limitations including small sample size, lack of a control group and limited training sessions. Consequently, no firm conclusion regarding the benefit of body weighted supported treadmill training in persons with MS can be drawn. The proposed project seeks to determine if twenty-weeks of body weight supported treadmill training leads to improvements in physiological function, mobility and quality of life in persons with MS with severe mobility limitations. The outcomes of this project have the potential to lead to new rehabilitation approaches capable of improving function and quality of life in persons with advanced MS.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The criteria for inclusion are physician confirmed MS diagnosis, relapse free in the last 30 days, ability to voluntarily contract either quadriceps (e.g. extend their knee), willingness to complete 20 week intervention, and physician approval to engage in manual BWSTT. The diagnosis of MS based on either Poser's or McDonald's criteria and its type based on Lublin and Reingold criteria will be confirmed by the patient's neurologist using a standard form letter.

Exclusion criteria

  • The criteria for exclusion are having a relapse in the last 30 days, inability to contract the quadriceps, and unwilling to complete the 20 week intervention.

Treatment and study plan

Exercise group

Behavioral

The BWSTT program will consist of biweekly training sessions for 20 weeks. Per neurorecovery network guidelines, each training session will include a minimum of 20 minutes of locomotor training and 20 minutes of balance training. Training will take place on a Therastride which consists of a treadmill with an air pressure powered pulley system connected to a harness system. The locomotor training strategy focuses on proper gait mechanics, including weight bearing, shifting and maintaining body positioning. Manipulating the participant's legs is done in such a way as to provide appropriate sensory-motor cues that facilitate the development and refinement of walking pattern.

Other names: Body-weight supported treadmill triaining

Primary outcomes

  1. Clinical Disability

    Time frame: 5 months

    Clinical disability will be indexed by expanded disability status scale.

  2. Quality of Life

    Time frame: 5 months

    Quality of life will be indexed with the Multiple Sclerosis Quality of Life-54 (MSQoL-54) and participation will be indexed with the community participation indicator.

Secondary outcomes

  1. Walking function

    Time frame: 5 months

    Walking speed will be quantified with the Timed 25-Foot Walk and walking endurance will be quantified with the 6-Minute Walk. The Multiple Sclerosis Walking Scale-12 (MSWS-12) will be used as a self-reported measure of walking impairment.

  2. Balance

    Time frame: 5 months

    Balance will be quantified with the Berg Balance Scale (BBS); self-report of balance confidence (ABC), and force platform metrics (sway range and velocity).

  3. Cardiorespiratory fitness

    Time frame: 5 months

    Cardiorespiratory fitness will be measured as peak oxygen consumption (VO2peak) using an incremental exercise test using an total body recumbent stepper and an open-circuit spirometry system.

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Registry information

Official study title

Body Weight Supported Treadmill Training in Advanced Multiple Sclerosis

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 25, 2013
Registry last updated
Dec 12, 2014

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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