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.
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.
United States1 site, 1 recruiting
- 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
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.
- Conditions
- Multiple Sclerosis
- 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 group | Role | What they receive |
|---|---|---|
| Persons with Multiple sclerosis | Persons 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.
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)
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.
- First posted23 Oct 2023
- Study start2 Nov 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hunter College of City University of New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Herbert Karpatkin, Dsc, Principal investigator, Hunter College Physical therapy Department, City University of New York
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cooling on Balance Performance in Persons With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06094855
- Acronym / sponsor ID
- 2023-0489-Hunter
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hunter College of City University of New YorkUniversity, hospital or other
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persons with Multiple sclerosis | – | Other: 20 minutes of biking on a stationary recumbent bicycle with and without a cooling vestPersons with a diagnosis of Multiple Sclerosis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Community dwelling adults with Multiple Sclerosis
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 20 minutes of biking on a stationary recumbent bicycle with and without a cooling vest2 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. | Other | Persons with Multiple sclerosis |
Primary outcome
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.
The MBT is a valid and reliable tool used to measure balance performance and falls risk in persons with MS.
1 secondary outcome
Visual Analog Scale of Fatigue
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Herbert Karpatkin, Dsc principal investigator
Hunter College Physical therapy Department, City University of New York
1 site in 1 country: see every site and its status.
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.