FallsNCT05615207
The Effect of Motor Imagery on Balance in Persons With Multiple Sclerosis
A study testing Motor Imagery as compared to physical practice for balance tasks in people with Falls and Motor Imagery, run by Dominican University New York at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Falls, Motor Imagery, Multiple Sclerosis
- What is being tested?
- Motor Imagery as compared to physical practice for balance tasks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed diagnosis of Multiple Sclerosis
- A non-perfect score on the Berg Balance Scale
Who cannot join
- A perfect score on the Berg Balance Scale
- Current participation in a program focused on improving balance
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Dominican University New York
Orangeburg, New York, 10962
Stefanie DiCarrado, DPT, 914-213-1284, stefanie.dicarrado@duny.edu
About this study
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.
Read the detailed 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:
- 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.
- Conditions
- Falls, Motor Imagery, Multiple Sclerosis, Balance, Fatigue
- Being tested
- Motor Imagery as compared to physical practice for balance tasks
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Imagery as compared to physical practice for balance tasksOther
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
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (physical practice) | Active comparator | Participants will be given a single one on one in person instruction session and a home exercise program corresponding to their assigned group with instructions on physical practice. The Standard of Care / Physical practice will include physically performing movements that closely or entirely mimic elements of the BBS. For example, if a subject struggles with the sit to stand portion of the BBS, they will physically practice sit to stand based on the treating physical therapist's clinical decision of appropriate task parameters and dosage. The individual subject's MS fatigue and their performance of the task will be taken into account when deciding dosage. Receives: Other: Motor Imagery as compared to physical practice for balance tasks |
| Motor Imagery | Experimental | Participants will be given a single one on one in person instruction session and a home exercise program corresponding to their assigned group with instructions on using motor imagery to imagine themselves performing the balance task with which they struggled on the BBS. Motor imagery practice involves having the participant imagine themselves performing elements of the BBS without physically moving. The participants in this group will be guided through 1 session of motor imagery that will be recorded on their person phone for them to use as a home exercise program. Receives: Other: Motor Imagery as compared to physical practice for balance tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two weeks
Secondary outcomes (3)
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.
Measured: Two weeks
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.
Measured: Two weeks
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.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 Jan 2023
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial - participants will 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dominican University New York
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefanie DiCarrado, Dominican University New York
- Investigators
- Stefanie DiCarrado, DPT, Principal investigator, Dominican University New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615207
- Sponsor's protocol ID
- 001
- Status last verified
- Feb 2023
- First submitted
- 7 Nov 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We are happy to share data if there are similar studies occurring where their protocols are similar enough that direct comparisons can be made between groups' pre and post test results.
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motor Imagery on Balance in Persons With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05615207
- Acronym / sponsor ID
- 001
- Conditions
- Falls, Motor Imagery, Multiple Sclerosis, Balance, Fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Dominican University New YorkUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 14 Nov 2022 (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.
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.
Detailed 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial - participants will 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.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (physical practice) | Active comparator | Other: Motor Imagery as compared to physical practice for balance tasksParticipants will be given a single one on one in person instruction session and a home exercise program corresponding to their assigned group with instructions on physical practice. The Standard of Care / Physical practice will include physically performing movements that closely or entirely mimic elements of the BBS. For example, if a subject struggles with the sit to stand portion of the BBS, they will physically practice sit to stand based on the treating physical therapist's clinical decision of appropriate task parameters and dosage. The individual subject's MS fatigue and their performance of the task will be taken into account when deciding dosage. |
| Motor Imagery | Experimental | Other: Motor Imagery as compared to physical practice for balance tasksParticipants will be given a single one on one in person instruction session and a home exercise program corresponding to their assigned group with instructions on using motor imagery to imagine themselves performing the balance task with which they struggled on the BBS. Motor imagery practice involves having the participant imagine themselves performing elements of the BBS without physically moving. The participants in this group will be guided through 1 session of motor imagery that will be recorded on their person phone for them to use as a home exercise program. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed diagnosis of Multiple Sclerosis
- A non-perfect score on the Berg Balance Scale
Key exclusion criteria (2 listed)
- A perfect score on the Berg Balance Scale
- Current participation in a program focused on improving balance
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 |
|---|---|---|
| Motor Imagery as compared to physical practice for balance tasksWe will investigate if using motor imagery (mentally imagining and practicing a task) as a means of balance training is as effective as physical practice | Other | Motor Imagery, Standard of Care (physical practice) |
Primary outcome
Berg Balance Test
Time frame: Two weeks
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.
3 secondary outcomes
MS Impact Scale-29 (MSIS29)
Time frame: Two weeks
Fatigue Severity Scale (FSS)
Time frame: Two weeks
Activities-Specific Balance Confidence scale (ABC)
Time frame: Two weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: Yes. We are happy to share data if there are similar studies occurring where their protocols are similar enough that direct comparisons can be made between groups' pre and post test results.
Related trials for Falls
Not yet recruiting
Comparative Effects of Exercises on Reactive Balance and Fall Risk in Community-Dwelling Older Adults
COMMUNITY-DWELLING OLDER ADULTS
Recruiting
Effects of Virtual Reality Environments on Walking in Adults With and Without Knee Osteoarthritis
Knee Osteoarthritis
RecruitingPhase 4
Testing Healthy Participants for Drowsiness After Single Dosing of Two Different Doses of Muscle Relaxer
Healthy Participants
Not yet recruiting
Pilates vs. Core Stabilization for Balance and Mobility in Elderly Type 2 Diabetics
Mellitus Balance Deficits Postural Balance Mobility Limitation, Type 2 Diabetes Mellitus
Recruiting
Evaluation of the PPAL
Age Problems
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. This study is not recruiting at the moment.
Stefanie DiCarrado, DPT principal investigator
Dominican University New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor Imagery as compared to physical practice for balance tasks in people with Falls and Motor Imagery, run by Dominican University 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 2 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: status not confirmed, as of the sponsor's last update on 8 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefanie DiCarrado, DPT (9142131284, stefanie.dicarrado@duny.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Test (time frame: Two weeks). 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 8 Feb 2023.