The Effect of Motor Imagery on Balance in Persons With Multiple Sclerosis

NCT05615207 | Unknown

• 1 other identifier: 001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Falls; Motor Imagery; Multiple Sclerosis; Balance; Fatigue

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• MS Impact Scale-29 (MSIS29)

  Two weeks

• Fatigue Severity Scale (FSS)

  Two weeks

• Activities-Specific Balance Confidence scale (ABC)

  Two weeks

Study Arms (2)

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.

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.

Other: Motor Imagery as compared to physical practice for balance tasks

Interventions

Motor Imagery as compared to physical practice for balance tasks OTHER

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

Motor Imagery; Standard of Care (physical practice)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of Multiple Sclerosis
• A non-perfect score on the Berg Balance Scale

You may not qualify if:

• A perfect score on the Berg Balance Scale
• Current participation in a program focused on improving balance

Sponsors & Collaborators

• Dominican University New York: lead

Study Sites (1)

Dominican University New York

Orangeburg, New York, 10962, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefanie DiCarrado, DPT

  Dominican University New York

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefanie DiCarrado, DPT

CONTACT

9142131284; stefanie.dicarrado@duny.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subject group allocation will be concealed from individuals involved in pre \& post test outcome measurements.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 14, 2022
• Study Start: January 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data should be available around November 2023.

Locations

US (1)