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High Intensity Interval Gait Training in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Intensity Interval Gait training
Moderate Intensity Interval gait training
Sponsored by
Hunter College of City University of New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hunter CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Intensity Interval gait training

Moderate intensity continuous gait training

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Functional gait assessment score from before to after the intervention
Used to assess balance during different walking conditions
Change in Hand held dynamometry values from before to after the intervention
Use of the strain gauge to determine lower extremity muscle strength
Change in Multiple sclerosis impact scale 29 from before to afterthe intervention
Quality of life measure where are the subject subjectively rates the impact of multiple sclerosis on their life

Full Information

First Posted
September 22, 2022
Last Updated
October 5, 2022
Sponsor
Hunter College of City University of New York
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1. Study Identification

Unique Protocol Identification Number
NCT05560880
Brief Title
High Intensity Interval Gait Training in Multiple Sclerosis
Official Title
The Effects of High Intensity Interval Gait Training vs. Moderate Intensity Continuous Gait Training in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hunter College of City University of New York

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Intensity Interval gait training
Arm Type
Experimental
Arm Description
subjects will receive 3x/week high intensity interval training for 20 minutes over a 4 week period
Arm Title
Moderate intensity continuous gait training
Arm Type
Active Comparator
Arm Description
subjects will receive 3x/week moderate intensity continuous gait training for 20 minutes over a 4 week period
Intervention Type
Behavioral
Intervention Name(s)
High Intensity Interval Gait training
Intervention Description
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
Intervention Name(s)
Moderate Intensity Interval gait training
Intervention Description
subjects will walk for 20 minutes at theri best comfortable pace
Primary Outcome Measure Information:
Title
Change in Six minute walk test time from before to after the intervention
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Change in Functional gait assessment score from before to after the intervention
Description
Used to assess balance during different walking conditions
Time Frame
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.
Title
Change in Hand held dynamometry values from before to after the intervention
Description
Use of the strain gauge to determine lower extremity muscle strength
Time Frame
Will be done the week before and the week after the intervention.
Title
Change in Multiple sclerosis impact scale 29 from before to afterthe intervention
Description
Quality of life measure where are the subject subjectively rates the impact of multiple sclerosis on their life
Time Frame
Performed in the week before and the week after the intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Herb Karpatkin, DSc
Phone
212-396-7115
Email
hkarpatk@hunter.cuny.edu
Facility Information:
Facility Name
Hunter College
City
New York
State/Province
New York
ZIP/Postal Code
11238
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Herb Karpatkin, DSc
Phone
212-396-7115
Email
hkarpatk@hunter.cuny.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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High Intensity Interval Gait Training in Multiple Sclerosis

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