Body Weight Supported Treadmill Training in Persons With Multiple Sclerosis

NCT01992679 | Completed Phase 1

• 1 other identifier: NMSS-IL-011
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Clinical Disability

  Clinical disability will be indexed by expanded disability status scale.

  5 months

• Quality of Life

  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.

  5 months

Secondary Outcomes (3)

• Walking function

  5 months

• Balance

  5 months

• Cardiorespiratory fitness

  5 months

Study Arms (2)

Control

NO INTERVENTION

Participants in the control group will undergo the same assessments but receive no exercise stimulus and be asked to maintain current physical levels

Exercise group

EXPERIMENTAL

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

Interventions

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.

Also known as: Body-weight supported treadmill triaining

Exercise group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead

Study Sites (1)

University of Illinois UC

Urbana-Champaign, Illinois, 61801, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jacob Sosnoff, PhD

  University of Illinois at Urbana-Champaign

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 12, 2013
• First Posted: November 25, 2013
• Study Start: October 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 12, 2014

Record last verified: 2014-12

Locations

US (1)