Balance Targeted Exercises for Individuals With MS

NCT06159361 | Completed

• 1 other identifier: 20231151
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (2)

• Change in balance confidence as measured by ABC

  Baseline, 6 weeks (post intervention)

• Change in quality of life as measured by the MSQoL-54

  Baseline, 6 weeks (post intervention)

Study Arms (1)

Balance targeted exercises group

EXPERIMENTAL

participants in this group will receive the balance targeted exercises for up to 6 weeks

Behavioral: Balance targeted exercises

Interventions

Balance targeted exercises BEHAVIORAL

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.

Balance targeted exercises group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• James Moore, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of clinical

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 6, 2023
• Study Start: December 6, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 30, 2024
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)