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Clinical Trials/NCT03963492
NCT03963492
Suspended
Not Applicable

Intermittent vs. Continuous Walking Training in People With Multiple Sclerosis: a Comparison of Effectiveness

Rutgers, The State University of New Jersey1 site in 1 country24 target enrollmentJuly 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Rutgers, The State University of New Jersey
Enrollment
24
Locations
1
Primary Endpoint
Change in 6-minute Walk Test distance
Status
Suspended
Last Updated
3 years ago

Overview

Brief Summary

This study will compare the effectiveness of a traditional, continuous walking rehabilitation program for people with MS to the novel intervention of an intermittent or interval walking rehabilitation program. Half of the participants will receive the continuous walking program while the other half will receive the novel intermittent walking program.

Detailed Description

The typical rehabilitation of walking difficulties for people with MS has included practice walking. In general, this includes training to build walking endurance by having the person with MS walk until he/she becomes tired and needs to stop. Although this model has been used successfully to treat people with other diagnoses, it has limited effectiveness in improving walking ability and endurance in people with MS because of fatigue. Recently, a different model has been considered: intermittent or interval walking training. Interval walking training is organized such that seated rest breaks are intentionally interspersed between walking training bouts that end before the person with MS becomes too tired to continue. Exploratory research has shown that people with MS can walk faster and farther when using interval walking training, and may have more improvements in walking ability and endurance after using interval walking training. This study will compare the effectiveness of the traditional model of continuous walking training to the promising new model of interval walking training. This will help to determine whether interval or continuous walking training is superior in improving walking ability and endurance in people with MS.

Registry
clinicaltrials.gov
Start Date
July 1, 2019
End Date
February 28, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Evan T. Cohen, SHRP Department of Rehabilitation and Movemen

Associate Professor

Rutgers, The State University of New Jersey

Eligibility Criteria

Inclusion Criteria

  • Self-identified difficulty walking
  • Definitive diagnosis of multiple sclerosis from a neurologist
  • Signed an approved consent form
  • Ability to ambulate for unaided for 6-minutes continuously with or without an assistive device (e.g. a cane or brace)
  • Has not had a multiple sclerosis relapse in the past 6 weeks

Exclusion Criteria

  • Unwilling or unable to complete assessments
  • Unwilling or able to complete assessments and or intervention without the use of portable functional electrical stimulation devices
  • Medical history of concomitant condition unrelated to multiple sclerosis which may impact results including: other neurological conditions including stroke, Parkinson's disease, or orthopedic, or cardiopulmonary conditions that affect walking
  • Had a major change in exercise habits in the past three months
  • Individuals reporting change in any disease modifying treatment or steroid use during the past 6 weeks
  • Unable to walk for 6 minutes continuously without physical assistance
  • Medical history of unstable angina, uncontrolled cardiac dysrhythmias causing symptoms, symptomatic severe aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus or pulmonary infarction, history of deep vein thrombosis, acute myocarditis or pericarditis, acute systemic infection, uncontrolled hypertension, and uncontrolled diabetes
  • Has an abnormal response to exercise
  • Cannot adhere to protocol
  • Determined to be unsafe at the discretion of the research team including individuals unwilling to wear safety "gait belt" during testing or not willing to wear proper footwear.

Outcomes

Primary Outcomes

Change in 6-minute Walk Test distance

Time Frame: Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)

Is a measurement of the distance (in meters) walked at best pace in six minutes.

Secondary Outcomes

  • Change in Step Time(Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up))
  • Change in Stride Velocity(Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up))
  • Change in Fatigue Severity Scale score(Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up))
  • Change in Step Length(Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up))
  • Change in Cadence(Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up))
  • Change in 12-item Multiple Sclerosis Walking Scale score(Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up))

Study Sites (1)

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