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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

Effect of Cooling on Balance Performance in Multiple Sclerosis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06094855
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hunter College of City University of New York
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Herbert Karpatkin, Dsc
Principal Investigator Affiliation Hunter College Physical therapy Department, City University of New York
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Sclerosis
Additional Details

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.

Arms & Interventions

Arms

: Persons with Multiple sclerosis

Persons with a diagnosis of Multiple Sclerosis

Interventions

Other: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

New York, New York

Status

Recruiting

Address

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

New York, New York, 10010

Site Contact

Herbert Karpatkin, DSc

[email protected]

212-396-7115

Nearest Location

Site Contact

Herbert Karpatkin, DSc

[email protected]

212-396-7115


Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

Read more

Read more

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

Visit NARCOMS

Visit NARCOMS

Posting a Trial

If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

Powered By

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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