Balance Targeted Exercises for Individuals With MS

Not Applicable

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT06159361
• Lead Sponsor: University of Miami

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-11-28
• Study First Submitted QC: 2023-11-28
• Study Start: 2023-12-06
• Study First Posted: 2023-12-06
• Primary Completion: 2024-09-01
• Study Completion: 2024-12-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in endpoint excursion percentage	Baseline, 6 weeks (post intervention)	measure of endpoint excursion in a percentage out of a100
Change in balance ability as measured by the BESTest	Baseline, 6 weeks (post intervention)	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.
Change in movement velocity	Baseline, 6 weeks (post intervention)	Measure in degree per second
Change in CPA as measured by microvolts	Baseline, 6 weeks (post intervention)	Postural muscles CPA in microvolts
Change in muscle responses latency as measured by MCT	Baseline, 6 weeks (post intervention)	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.
Change in directional control percentage	Baseline, 6 weeks (post intervention)	measure of directional control in a percentage out of a100
Change in maximum excursion percentage	Baseline, 6 weeks (post intervention)	measure of maximum excursion in a percentage out of a100
Change in postural muscles responses latency as measured by Electromyography (EMG)	Baseline, 6 weeks (post intervention)	Postural muscles responses onset latency in seconds
Change in APA as measured by microvolts	Baseline, 6 weeks (post intervention)	Postural muscles APA measured in microvolts
Change in reaction time	Baseline, 6 weeks (post intervention)	Measure in seconds

Secondary Outcome Measures

Name	Time	Method
Change in balance confidence as measured by ABC	Baseline, 6 weeks (post intervention)	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.
Change in quality of life as measured by the MSQoL-54	Baseline, 6 weeks (post intervention)	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

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States