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.
