We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

High Intensity Interval Gait Training in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05529498
Recruitment Status : Recruiting
First Posted : September 7, 2022
Last Update Posted : September 7, 2022
Sponsor:
Information provided by (Responsible Party):
Herbert Karpatkin, City University of New York

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis,Gait, Exercise Behavioral: Moderate paced continuous gait training Behavioral: High Intensity Interval gait training Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 group pretest postest
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of High Intensity Interval Gait Training on Ambulation in MS
Actual Study Start Date : September 2, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental
High intensity interval gait training
Behavioral: High Intensity Interval gait training
20 minutes of interspersing 30 seconds of fast walking with 1 minute of rest

Active Comparator: Control
Moderate intesnity continuous gait training
Behavioral: Moderate paced continuous gait training
walking continuously for 20 minutes at a moderate pace




Primary Outcome Measures :
  1. 6 minute walk test [ Time Frame: 6 minutes ]
    Distance covered during continuous walking for 6 minutes


Secondary Outcome Measures :
  1. Finctional gait assessment [ Time Frame: 10 minutes ]
    balance during walking



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Persons diagnosed with Multiple Sclerosis. Rationale:because we are studying effects of the intervention on participant with MS

  • 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05529498


Contacts
Layout table for location contacts
Contact: Herbert Karpatkin, DSc 212-396-7115 hkarpatk@hunter.cuny.edu
Contact: Jaya Rachwani, PhD (212) 481-4321 jr5856@hunter.local

Locations
Layout table for location information
United States, New York
Hunter College Recruiting
New York, New York, United States, 11238
Contact: Herbert Karpatkin, DSc    212-396-7115    hkarpatk@hunter.cuny.edu   
Sponsors and Collaborators
City University of New York
Layout table for additonal information
Responsible Party: Herbert Karpatkin, Associate Professor, City University of New York
ClinicalTrials.gov Identifier: NCT05529498    
Other Study ID Numbers: CityUNewYork
First Posted: September 7, 2022    Key Record Dates
Last Update Posted: September 7, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases