Balance Targeted Exercises for Individuals With MS

The Effect of a Targeted Exercise Program on Balance and Postural Responses in Patients With Multiple Sclerosis (MS)

The purpose of this study is to examine the effects of a postural adjustment, targeted training program on balance ability and postural responses anticipatory postural adjustments (APA) and compensatory postural adjustments (CPA) in individuals with MS

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Balance targeted exercises

Detailed Description

All participants participated in individual training program aimed at improving balance ability and postural adjustments. The training program and individual activities were based on previously published programs and motor learning principles, and consists of 18, 1-hour training sessions over six weeks (3 sessions/week). Training occurred in person 2 days a week (in person training) and at home (home exercise program) 1 day a week, for a total of 3 sessions per week. The duration of training sessions were 60 minutes per session for a total of 1,140 minutes of training. The exercise room temperature was centrally regulated (23.3 degrees C).

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Must be18 to 70 years of age.
2. Medical diagnosis of MS confirmed by a neurologist.
3. Ability to stand independently without any aid for at least 3 minutes.
4. A Patients determined disease steps (PDDS) score of 5 or lower.
5. Normal or corrected-to-normal vision.
6. English or Spanish speaking.

Exclusion Criteria:

1. MS-related exacerbation or medication change in the past two months.
2. Presence of concurrent neurological or orthopedic disorders.
3. Unable to perform the experimental tasks.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Balance targeted exercises group; participants in this group will receive the balance targeted exercises for up to 6 weeks	Behavioral: Balance targeted exercises; 6-week exercise program, 3 sessions per week (2 sessions in person, 1 session of home exercises. Participants will receive a booklet with information about the home exercises and will receive a text message reminder), each session will last 60 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in balance ability as measured by the BESTest	The Balance Evaluation Systems Test (BESTest) will be used to measure balance ability. Items are scored from 0 (severe impairment) to 3 (no impairment), with a total score of 108. A higher score suggests better balance ability.	Baseline, 6 weeks (post intervention)
Change in reaction time	Measure in seconds	Baseline, 6 weeks (post intervention)
Change in movement velocity	Measure in degree per second	Baseline, 6 weeks (post intervention)
Change in endpoint excursion percentage	measure of endpoint excursion in a percentage out of a100	Baseline, 6 weeks (post intervention)
Change in directional control percentage	measure of directional control in a percentage out of a100	Baseline, 6 weeks (post intervention)
Change in maximum excursion percentage	measure of maximum excursion in a percentage out of a100	Baseline, 6 weeks (post intervention)
Change in muscle responses latency as measured by MCT	The Motor Control test (MCT) measures the subject's ability to generate a motor response latency to a sudden surface translation in a forward and backward direction at three different magnitudes (small, medium, and large). Latency: The time-lapse between the perturbation onset and the subject response for each limb. The latency is reported in milliseconds.	Baseline, 6 weeks (post intervention)
Change in postural muscles responses latency as measured by Electromyography (EMG)	Postural muscles responses onset latency in seconds	Baseline, 6 weeks (post intervention)
Change in APA as measured by microvolts	Postural muscles APA measured in microvolts	Baseline, 6 weeks (post intervention)
Change in CPA as measured by microvolts	Postural muscles CPA in microvolts	Baseline, 6 weeks (post intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in balance confidence as measured by ABC	The Activities Specific Balance Confidence (ABC) scale is a self-report questionnaire of a subject's perceived level of balance confidence. It measures the subject's confidence in performing various ambulatory activities without falling. There are 16 items scored using a scale(0-100) with higher scores indicating more confidence in performing the tasks. A total score is reported by dividing the total ABC score by 16.	Baseline, 6 weeks (post intervention)
Change in quality of life as measured by the MSQoL-54	Multiple Sclerosis Quality of Life - 54 (MSQoL-54) is a self-report questionnaire measuring subject perceived of quality of life. In total, it contains 54 items with a total score ranging from 0-100, with higher scores indicating a better quality of life	Baseline, 6 weeks (post intervention)

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: James Moore, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2023
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: November 28, 2023
• First Posted (Actual): December 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 30, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 20231151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No