Effect of Cooling on Balance Performance in Multiple Sclerosis
Part of paid clinical trials in New York, New York.
- Sponsor
- Hunter College of City University of New York
- Study ID
- NCT06094855
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- 20 minutes of biking on a stationary recumbent bicycle with and without a cooling vest — OTHER2 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.
Study Details
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.
Key Dates
- Start date
- Nov 2, 2023
- Status verified
- Nov 2023
- Primary completion
- Dec 31, 2025
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 30 participants (estimated)
Arms
- Arm: Persons with Multiple sclerosisPersons with a diagnosis of Multiple Sclerosis
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
- Herbert Karpatkin, DSc212-396-7115
- Jaya Rachwani, PhD212-396-7108
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Hunter College, Physical Therapy Department, City University of New York | New York | New York | 10010 |
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