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Multiple SclerosisNCT06094855

Effect of Cooling on Balance Performance in Multiple Sclerosis

An observational study of Multiple Sclerosis, run by Hunter College of City University of New York at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
20 minutes of biking on a stationary recumbent bicycle with and without a cooling vest
How many people
30 participants
Where
1 siteUnited States
Study dates
2 Nov 2023to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Adult, Older adult

Study population: Community dwelling adults with Multiple Sclerosis

Who may be able to join

None listed.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Herbert Karpatkin, DSc contact

212-396-7115

hkarpatk@hunter.cuny.edu

Jaya Rachwani, PhD contact

212-396-7108

jr5856@hunter.cuny.edu

United States1 site, 1 recruiting
  • Hunter College, Physical Therapy Department, City University of New York

    New York, New York, 10010

    Herbert Karpatkin, DSc, 212-396-7115, hkarpatk@hunter.cuny.edu

    Recruiting

Other trials in United States

About this study

Official title: Effect of Cooling on Balance Performance in Persons With Multiple Sclerosis

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.

Read the detailed description

The purpose of this study is to investigate the effectiveness of cooling on balance performance on persons with MS(pwMS). Multiple studies have provided evidence that cooling can improve gait performance in MS; this will be the first study that examines the effect of cooling on balance. We hypothesize that persons with MS will have better balance performance when cooled, as opposed to a non-cooled condition. If our hypothesis is correct, it will suggest that physical therapists who work with pwMS can use cooling as a modality to improve balance. Outcomes will be shared via conference presentations through American Physical Therapy Association, Consortium of Multiple Sclerosis Centers, and publications in peer-reviewed journals. Results will also be shared with academic colleagues at other teaching centers.

Although cooling has been studied for its effects on gait in pwMS, our study will be the first to observe its effectiveness in improving balance. We are operationally defining improvement in balance by increase in score in the mini Balance Evaluation Systems Test, a valid and reliable tool for measuring balance and performance in MS. We are operationally defining cooling by the wearing of a commercially available cooling vest. Participants will be identified by contacting local area MS practices and support groups as well as posting our study on ClinicalTrials.gov. Consent will be obtained at the physical therapy department of Hunter College. Consent is obtained when the potential subject arrives prior to obtaining any demographic or subject characteristic information. As this is a randomized crossover trial, participants will be randomized into either a cooled or non-cooled condition. Following completion of experiencing one condition, they will then "cross over" and experience the other condition; subjects previously in the cooled group will cross over to the uncooled group and subjects in the uncooled group will crossover into the cooled group. Procedures will take place in the Physical Therapy department at Hunter College. Each subject will have to attend the Hunter College Physical Therapy department for 60-90 minutes, 2 times, 1-2 weeks apart. Prior to randomization, the following demographic and subject characteristic data will be collected: 1. Subject demographics and characteristics, 2. Multiple Sclerosis Impact Scale 29 (MSIS-29), 3. Fatigue Severity Scale, 4. Mini BESTest, 5. Activities-specific Balance Confidence Scale (ABC), This data will be collected to get a better description of the subject. Data will be collected on paper forms. There will not be interview/focus groups/survey questions.

Following collection of this data subjects will be randomized into either a cooled or uncooled condition via picking odd or even numbers out of a hat.

Subjects will then ride a stationary bicycle in order to induce fatigue. The protocol for the stationary bike ride is as follows:

Depending on randomization, subjects will ride the stationary bike either wearing the cooling vest (cooled condition) or not (uncooled condition). Immediately after the biking the subjects will repeat the Mini Balance Evaluation Systems Test. One week later, the subjects will return and repeat the balance testing and biking but in the opposite condition to what they were tested in previously.

Being tested
20 minutes of biking on a stationary recumbent bicycle with and without a cooling vest
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

Study groups in NCT06094855
Study groupRoleWhat they receive
Persons with Multiple sclerosisPersons with a diagnosis of Multiple Sclerosis
Receives: Other: 20 minutes of biking on a stationary recumbent bicycle with and without a cooling vest

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)
  1. Visual Analog Scale of Fatigue

    The Visual Analog Scale of Fatigue is used to measure subjective feelings of fatigue during a performance of a specific task.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2023
  2. Study start2 Nov 2023
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06094855
Sponsor's protocol ID
2023-0489-Hunter
Status last verified
Nov 2023
First submitted
25 Sep 2023
Last updated
15 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis, run by Hunter College of City University of New York at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Herbert Karpatkin, DSc (212-396-7115, hkarpatk@hunter.cuny.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.

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