High Intensity Interval Gait Training in Multiple Sclerosis

NCT ID: NCT05560880

Last Updated: 2022-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Purpose: To determine whether pwMS will have greater improvements in gait with HIIGT as compared to MICGT.

Primary Question: Does HIIGT results in greater improvements in gait parameters in pwMS than MICGT? Secondary question: Will HIIGT result in greater improvements in balance, lower extremity strength, lower extremity range of motion and HR when compared to MICGT in pwMS?

Hypothesis: HIIGT will result in greater improvements in gait parameters in pwMS than MICGT.

Justification: Previous research has shown that MICGT, moderate intensity interval training and high intensity non-gait interval training is effective in pwMS. HIIGT has been shown to be effective in persons with stroke but the effects of HIIGT on pwMS are not known.

Outcomes and dissemination of information: We will present our findings at national conferences and submit manuscripts of our findings to the appropriate peer reviewed journal.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High Intensity Interval gait training

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

Group Type EXPERIMENTAL

High Intensity Interval Gait training

Intervention Type 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.

Moderate intensity continuous gait training

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

Group Type ACTIVE_COMPARATOR

Moderate Intensity Interval gait training

Intervention Type BEHAVIORAL

subjects will walk for 20 minutes at theri best comfortable pace

Interventions

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High Intensity Interval Gait training

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.

Intervention Type BEHAVIORAL

Moderate Intensity Interval gait training

subjects will walk for 20 minutes at theri best comfortable pace

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hunter College of City University of New York

OTHER

Sponsor Role lead

Responsible Party

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Herbert Karpatkin

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hunter College

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Herb Karpatkin, DSc

Role: CONTACT

212-396-7115

Facility Contacts

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Herb Karpatkin, DSc

Role: primary

212-396-7115

Other Identifiers

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2022-0261

Identifier Type: -

Identifier Source: org_study_id

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