Intermittent vs Continuous Walking in People With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03963492
• Other study ID #: Pro2019000453
• Status: Suspended
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: February 28, 2023

Study information

• Verified date: May 2022
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 24
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Walking
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.

Locations

Country	Name	City	State
United States	Mandell Center for Multiple Sclerosis - Mount Sinai Rehabilitation Hospital	Hartford	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	City University of New York, School of Public Health, Mount Sinai Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 6-minute Walk Test distance	Is a measurement of the distance (in meters) walked at best pace in six minutes.	Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
Secondary	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.	Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
Secondary	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.	Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
Secondary	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.	Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
Secondary	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.	Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
Secondary	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	Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)
Secondary	Change in Cadence	The number of steps (the initial contact of one foot to the initial contact of the opposite foot taken per minute	Baseline, 6 weeks (after intervention), and 12 weeks (6-week follow-up)