Recruiting

Cooling

Sponsor:

Hunter College of City University of New York

Code:

NCT06094855

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT06094855

Start date

Nov 2, 2023

Status verified date

Nov, 2023

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria: 1-Definitive diagnosis of Multiple Sclerosis 2-Capable of standing unassisted for at least 1 minute 3-ability to read and understand an informed consent 4- age 18-75

Exclusion Criteria:

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Persons with Multiple sclerosis

Persons with a diagnosis of Multiple Sclerosis

Interventions

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

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.

Primary outcome measure

  • Mini Balance Systems Evaluation Test [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Locations

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

Recruiting

New York, New York, United States, 10010

Contacts

More Information

Sponsor

Hunter College of City University of New York

Last update posted

Nov 15, 2023

Last verified

Nov, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hunter College of City University of New York on 2023-11-15.