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Body Weight Supported Treadmill Training in Persons With Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT01992679
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : December 12, 2014
Sponsor:
Information provided by (Responsible Party):
Jacob Sosnoff, University of Illinois at Urbana-Champaign

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Exercise group Phase 1 Phase 2

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Body Weight Supported Treadmill Training in Advanced Multiple Sclerosis
Study Start Date : October 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Participants in the control group will undergo the same assessments but receive no exercise stimulus and be asked to maintain current physical levels
Experimental: Exercise group
The exercise 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.
Behavioral: Exercise group
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 Name: Body-weight supported treadmill triaining




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992679


Locations
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United States, Illinois
University of Illinois UC
Urbana-Champaign, Illinois, United States, 61801
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
Investigators
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Principal Investigator: Jacob Sosnoff, PhD University of Illinois at Urbana-Champaign
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Responsible Party: Jacob Sosnoff, Associate Professor, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT01992679    
Other Study ID Numbers: NMSS-IL-011
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: December 12, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Body Weight
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases