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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05615207
Other study ID # 001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date November 1, 2023

Study information

Verified date February 2023
Source Dominican University of New York
Contact Stefanie DiCarrado, DPT
Phone 9142131284
Email stefanie.dicarrado@duny.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will investigate if the use of motor imagery to practice a balance task is as effective as physically practicing balance tasks as measured by the Berg Balance Scale (BBS) in persons with MS. A secondary purpose is to investigate if using a motor imagery balance intervention will limit fatigue typically experienced with physical movement in this population.


Description:

Motor Imagery, where persons practice mental performance of a task without the physical performance of the task has been found to improve many aspects of mobility in persons with MS. Its effect on balance is not known. Traditionally, balance training in persons with MS(pwms) has taken the form of physical performance of balance tasks. Although this is effective, this may increase the fatigue that commonly limits physical exercise in MS. The purpose of this study is to compare the effects of Motor Imagery on physical performance on balance and fatigue in persons with MS. Upon a participant's arrival to Dominican University NY, we will: A) Provide participants with an informed consent, explain the process, and answer questions B) Collect intake data (demographics and subject characteristics - age, gender, ethnicity, EDSS/ Phenotypes, years since diagnosis, MS Impact Scale-29 (MSIS29), Fatigue Severity Scale (FSS), Activities-Specific Balance Confidence scale (ABC) C) Collect baseline observational measures: Berg Balance Scale (BBS) The participants will then be randomized into the Standard of Care (physical practice) or the Motor Imagery group. Blocked randomization will be implemented to ensure even comparison between groups. Then each person will receive one on one training based on the item(s) on the BBS with which they had difficulty. For example, if the participant had difficulty with item 13 on the BBS, practicing that item would become part of their intervention. Participants in the Standard of Care group will be instructed on how to physically practice their items. Participants in the Motor Imagery group will be guided through mentally practicing their items. The interventionist will select the 3 items on the BBS with which the participant struggled the most and provide in person and HEP instructions based on those items. We will instruct the participant to perform 10 minutes of total daily practice of these exercises at home in the mode indicated by their group. The 10 minutes will be divided among multiple exercises if applicable and can be done either all at once or broken up over the course of the day. Participants will receive a logbook with written and/or verbally recorded instructions on how to perform their exercises. Participants will perform the interventions at home for 10 minutes a day for 2 weeks, and will then return to DUNY after the 2 weeks for post-test data collection.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date November 1, 2023
Est. primary completion date November 1, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Confirmed diagnosis of Multiple Sclerosis - A non-perfect score on the Berg Balance Scale Exclusion Criteria: - A perfect score on the Berg Balance Scale - Current participation in a program focused on improving balance

Study Design


Intervention

Other:
Motor Imagery as compared to physical practice for balance tasks
We will investigate if using motor imagery (mentally imagining and practicing a task) as a means of balance training is as effective as physical practice

Locations

Country Name City State
United States Dominican University New York Orangeburg New York

Sponsors (1)

Lead Sponsor Collaborator
Dominican University of New York

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Berg Balance Test The Berg Balance Scale (BBS) measures balance among older people with impairment in balance function by assessing the performance of functional tasks. It is a valid instrument used for the evaluation of the effectiveness of interventions and for quantitative descriptions of function in clinical practice and research. The BBS is comprised of a 14-item scale designed to measure the balance of the older adult in a clinical setting. Scoring: A five-point scale, ranging from 0-4. "0" indicates the lowest level of function and "4" is the highest level of function. Total Score = 56 Interpretation: 41-56 = low fall risk 21-40 = medium fall risk 0-20 = high fall risk. A change of 8 points is required to reveal a genuine change in function between 2 assessments. Participants who attain a perfect score on the BBS will be removed from the study. Participants who attain a non-perfect score on the BBS will be accepted into the study. Two weeks
Secondary MS Impact Scale-29 (MSIS29) The multiple Sclerosis Impact Scale has 29 questions that will be answered by the individuals in the study. It is a self-reported quality of life scale that measures the impact of MS on various quality of life measures. Question 1- 3 2 will ask, "In the past two weeks, how much has your MS limited your ability to..." Questions 4-29 will ask "In the past two weeks how much have you been bothered by..." The grading options range from 1-not at all, 2-a little, 3-moderately, 4-quite a bit, and 5-extremely. The main idea is to find out how MS has been impacting the participants. For each statement, they will choose the number that best describes their situation. This will be filled out pre and post training. Two weeks
Secondary Fatigue Severity Scale (FSS) This scale is a way to measure the participant's fatigue. There are 9 statements, with ratings from 1 to 7. 1 indicates 'strongly disagree' and 7 indicates 'strongly agree'. The Participants will be asked to complete this scale pre and post the intervention. Two weeks
Secondary Activities-Specific Balance Confidence scale (ABC) The ABC scale is a self-reported measure of the level of confidence in doing 16 different activities without losing balance or becoming unsteady. Participants choose one of the percentage points on the scale from 0% to 100% if participants do not currently do the activity they are asked to try and imagine how confident they would be if they had to do the activity. Participants rate their confidence in doing the activity using the amount of support they usually use. Two weeks
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