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SuspendedNCT03963492Updated May 12, 2022

Intermittent vs Continuous Walking in People With Multiple Sclerosis

An interventional study of Walking in Multiple Sclerosis, sponsored by Rutgers, The State University of New Jersey. Suspended at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-05-12.

Sponsored by Rutgers, The State University of New Jersey · Not applicable, Interventional, and Treatment

Why this study was suspended
COVID-19 Pandemic
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Multiple Sclerosis

Keywords

  • Walking
  • Gait
  • Fatigue
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In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's planned enrollment of 24 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
24 participants (estimated)

Study arms

  • Active comparator
    Continuous Walking

    Participants in the Continuous Walking (CONT) arm will undergo training 2x/week for 6 weeks for a total plan of 12 training sessions. The intervention for the CONT group will be to complete a 6-minute long walk without rest breaks

    Other: Walking

  • Experimental
    Interval Walking

    Participants in the Interval Walking (INT) arm will undergo training 2x/week for 6 weeks for a total plan of 12 training sessions. The intervention for the (INT) group will be to complete three 2-minute-long walks with 2-minute seated rest breaks between each walk

    Other: Walking

Interventions

  • OtherWalking

    Participants will undergo training in either the CONT or INT walking interventions 2x/week for 6 weeks for a total plan of 12 training sessions.

06

What researchers measure

Primary outcomes

  1. Change in 6-minute Walk Test distance

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

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

Secondary outcomes

  1. Change in 12-item Multiple Sclerosis Walking Scale score

    A survey that measures a participant's perception of how his/her walking ability is affected by multiple sclerosis. The scale ranges from 0-100 with lower scores representing a lesser impact of multiple sclerosis on the participant's walking ability. There are no subscales.

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

  2. Change in Fatigue Severity Scale score

    A survey that measures a participant's perception of the impact of the symptom of fatigue on a person's ability to participate in life roles. The scale ranges from from 9-63, with lower scores representing a lower impact of fatigue on the ability to perform the activities listed in the scale.There are no subscales.

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

  3. Change in Step Length

    The distance (in centimeters) traversed in one step from initial contact of one foot to the initial contact of the opposite foot.

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

  4. Change in Step Time

    The time (in seconds) taken to complete one step from initial contact of one foot to the initial contact of the opposite foot.

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

  5. Change in Stride Velocity

    The speed with which it takes a person to complete one stride from initial contact of one foot to the next initial contact of the same foot

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

  6. Change in Cadence

    The number of steps (the initial contact of one foot to the initial contact of the opposite foot taken per minute

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

07

Study locations

1 site
  • Mandell Center for Multiple Sclerosis - Mount Sinai Rehabilitation Hospital
    Hartford, Connecticut 06112, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03963492
Lead sponsor
Rutgers, The State University of New Jersey
Collaborators
Mount Sinai Rehabilitation Hospital, City University of New York, School of Public Health
Responsible party
Evan T. Cohen, SHRP Department of Rehabilitation and Movemen (Associate Professor, Rutgers, The State University of New Jersey) — Principal investigator
First posted
May 24, 2019
Start date
Jul 1, 2019
Primary completion
Feb 28, 2023 (estimated)
Completion
Feb 28, 2023 (estimated)
Last update
May 12, 2022

Study contacts

Evan T Cohen, PhD
principal investigator · Rutgers, The State University of New Jersey

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is suspended, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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