Effect of Cooling on Balance Performance in Multiple Sclerosis

NCT06094855 | Recruiting

• 1 other identifier: 2023-0489-Hunter
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study to examine the effects of cooling on balance in persons with Multiple Sclerosis. Persons with Multiple Sclerosis frequently have problems with balance leading to falls and related injuries, as well as avoidance of activities that may challenge balance. Persons with Multiple Sclerosis are also well known to experience worsening of their symptoms when they become too warm, a condition known as thermosensitivity. This suggests that heat may worsen balance and increase falls risk in persons with Multiple Sclerosis. In this study we are examining the effects of wearing a cooling vest on balance performance in persons with MS. The main questions our study aims to answer are: Question 1- Does wearing a cooling vest result in better balance performance in persons with MS when compared to a condition when they are not wearing the vest. Participants will be given a balance test to assess their baseline balance performance. Following the test participants will be randomly assigned to either a cooled or an uncooled condition. In the cooled condition, participants will wear a commercially available cooling vest while pedaling for 20 minutes at their best comfortable pace on a recumbent stationary bicycle. Immediately following the 20 minutes of exercise the vest shall be removed and the balance test repeated. Subjects in the uncooled condition will perform the same task but without wearing the vest. One week later, participants will return and will perform the opposite of what they did the previous week; subjects who were in the cooled group will perform the 20 minute exercise test without the cooling vest and subjects who were uncooled will perform the test with a cooling vest. The same balance test will be performed before and after the exercise bout.The change in the balance scores between the 2 conditions will be compared.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Mini Balance Systems Evaluation Test

  The MBT is a valid and reliable tool used to measure balance performance and falls risk in persons with MS.

  The test takes 15-20 minutes to administer. It will be administered 4 times; immediately before and immediately after the cooled cycling condition and immediately before before and immediately after the uncooled cycling condition.

Secondary Outcomes (1)

• Visual Analog Scale of Fatigue

  The test takes less than 1 minute to administer; It will be administered 4 times; immediately before and immediately after the cooled cycling condition and immediately before and immediately after the uncooled cycling condition.

Study Arms (1)

Persons with Multiple sclerosis

Persons with a diagnosis of Multiple Sclerosis

Other: 20 minutes of biking on a stationary recumbent bicycle with and without a cooling vest

Interventions

20 minutes of biking on a stationary recumbent bicycle with and without a cooling vest OTHER

2 bouts of 20 minutes of pedaling on a stationary recumbent bicycle, 1-2 weeks apart. Subjects will be cooled for one of the bouts and uncooled for the other.

Persons with Multiple sclerosis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community dwelling adults with Multiple Sclerosis

You may not qualify if:

• Any orthopedic, cardiopulmonary, or non-MS neurologic complication that would interfere with balance because it is study on Multiple Sclerosis.
• Under age 18 or over 75

Sponsors & Collaborators

• Hunter College of City University of New York: lead

Study Sites (1)

Hunter College, Physical Therapy Department, City University of New York

New York, New York, 10010, 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

Study Officials

• Herbert Karpatkin, Dsc

  Hunter College Physical therapy Department, City University of New York

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Herbert Karpatkin, DSc

CONTACT

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

Jaya Rachwani, PhD

CONTACT

212-396-7108; jr5856@hunter.cuny.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 23, 2023
• Study Start: November 2, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)