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Clinical Trials/NCT06159361
NCT06159361
Completed
Not Applicable

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

University of Miami1 site in 1 country7 target enrollmentDecember 6, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
University of Miami
Enrollment
7
Locations
1
Primary Endpoint
Change in reaction time
Status
Completed
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
December 6, 2023
End Date
December 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

James Moore

Associate professor of clinical

University of Miami

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

Change in reaction time

Time Frame: Baseline, 6 weeks (post intervention)

Measure in seconds

Change in endpoint excursion percentage

Time Frame: Baseline, 6 weeks (post intervention)

measure of endpoint excursion in a percentage out of a100

Change in balance ability as measured by the BESTest

Time Frame: 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

Time Frame: Baseline, 6 weeks (post intervention)

Measure in degree per second

Change in CPA as measured by microvolts

Time Frame: Baseline, 6 weeks (post intervention)

Postural muscles CPA in microvolts

Change in muscle responses latency as measured by MCT

Time Frame: 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

Time Frame: Baseline, 6 weeks (post intervention)

measure of directional control in a percentage out of a100

Change in maximum excursion percentage

Time Frame: 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)

Time Frame: Baseline, 6 weeks (post intervention)

Postural muscles responses onset latency in seconds

Change in APA as measured by microvolts

Time Frame: Baseline, 6 weeks (post intervention)

Postural muscles APA measured in microvolts

Secondary Outcomes

  • 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 Sites (1)

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