High Intensity Interval Gait Training in Multiple Sclerosis

NCT05560880 | Unknown

• 1 other identifier: 2022-0261
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Over 90% of persons with MS (pwMS) complain of difficulty with walking. High intensity interval gait training (HIIGT), where persons alternate brief periods of walking at high speeds with periods of rest has been found to improve walking in other neurologic diagnoses. However its impact on pwMS is not known. Most gait training in MS is done continuously at a slower pace. The purpose of this study is to compare the effects of HIIGT to traditional Moderate Intensity Continuous Gait Training (MICGT) in pwMS.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Change in Six minute walk test time from before to after the intervention

  Subjects will walk for six minutes at their best comfortable pace. They will be guarded by physical therapist for the entire walk. Total distance, distance per minute, and heart rate will be measured.

  The test will be administered to all subjects one week before and one week after the intervention.The test will be administered to all subjects one week before and one week after the intervention.

Secondary Outcomes (3)

• Change in Functional gait assessment score from before to after the intervention

  Will be done in the week before and the week after the intervention.Will be done in the week before and the week after the intervention.

• Change in Hand held dynamometry values from before to after the intervention

  Will be done the week before and the week after the intervention.

• Change in Multiple sclerosis impact scale 29 from before to afterthe intervention

  Performed in the week before and the week after the intervention.

Study Arms (2)

High Intensity Interval gait training

EXPERIMENTAL

subjects will receive 3x/week high intensity interval training for 20 minutes over a 4 week period

Behavioral: High Intensity Interval Gait training

Moderate intensity continuous gait training

ACTIVE COMPARATOR

subjects will receive 3x/week moderate intensity continuous gait training for 20 minutes over a 4 week period

Behavioral: Moderate Intensity Interval gait training

Interventions

High Intensity Interval Gait training BEHAVIORAL

Subjects will walk as fast as they can for 30 seconds, followed by a 60 second seated recovery. They will be guarded by a physical therapist at all times.

High Intensity Interval gait training

Moderate Intensity Interval gait training BEHAVIORAL

subjects will walk for 20 minutes at theri best comfortable pace

Moderate intensity continuous gait training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons diagnosed with Multiple Sclerosis.
• The ability to walk for 6 minutes continuously with or without assistive device.
• The ability to read, understand and sign a consent form so that they are able to understand the study we are doing
• Above the age of 18

You may not qualify if:

• Any cardiopulmonary, orthopedic, or non-MS neurologic disease as we are only examining the effects of MS and need to rule out the impact of other conditions
• Report of a recent exacerbation. Rationale: the impact of the rationale can interfere with the impact of the independent variables

Sponsors & Collaborators

• Hunter College of City University of New York: lead

Study Sites (1)

Hunter College

New York, New York, 11238, United States

RECRUITING

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

Central Study Contacts

Herb Karpatkin, DSc

CONTACT

212-396-7115; hkarpatk@hunter.cuny.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 30, 2022
• Study Start: September 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 6, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)