NCT05529498

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

September 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 7, 2022

Status Verified

September 1, 2022

Enrollment Period

1.3 years

First QC Date

September 2, 2022

Last Update Submit

September 2, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 6 minute walk test

    Distance covered during continuous walking for 6 minutes

    6 minutes

Secondary Outcomes (1)

  • Finctional gait assessment

    10 minutes

Study Arms (2)

Experimental

EXPERIMENTAL

High intensity interval gait training

Behavioral: High Intensity Interval gait training

Control

ACTIVE COMPARATOR

Moderate intesnity continuous gait training

Behavioral: Moderate paced continuous gait training

Interventions

walking continuously for 20 minutes at a moderate pace

Control

20 minutes of interspersing 30 seconds of fast walking with 1 minute of rest

Experimental

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The ability to walk for 6 minutes continuously with or without assistive device. Rationale:we are using the 6MWT as our primary outcome measure
  • 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 because they have to be able to give consent for the study
  • English speaking as we do not have the resources for translation for the multiple sessions this study entails

You may not qualify if:

  • Report of a recent exacerbation. Rationale: the impact of the rationale can interfere with the impact of the independent variables

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunter College

New York, New York, 11238, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Herbert Karpatkin, DSc

CONTACT

Jaya Rachwani, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 group pretest postest
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 2, 2022

First Posted

September 7, 2022

Study Start

September 2, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

September 7, 2022

Record last verified: 2022-09

Locations