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Completed

NCT Number: NCT06159361

Balance Targeted Exercises for Individuals With 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

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. Change in reaction time

    Time frame: Baseline, 6 weeks (post intervention)

    Measure in seconds

  3. Change in movement velocity

    Time frame: Baseline, 6 weeks (post intervention)

    Measure in degree per second

  4. Change in endpoint excursion percentage

    Time frame: Baseline, 6 weeks (post intervention)

    measure of endpoint excursion in a percentage out of a100

  5. Change in directional control percentage

    Time frame: Baseline, 6 weeks (post intervention)

    measure of directional control in a percentage out of a100

  6. Change in maximum excursion percentage

    Time frame: Baseline, 6 weeks (post intervention)

    measure of maximum excursion in a percentage out of a100

  7. 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.

  8. 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

  9. Change in APA as measured by microvolts

    Time frame: Baseline, 6 weeks (post intervention)

    Postural muscles APA measured in microvolts

  10. Change in CPA as measured by microvolts

    Time frame: Baseline, 6 weeks (post intervention)

    Postural muscles CPA in microvolts

Secondary outcomes

  1. Change in balance confidence as measured by ABC

    Time frame: 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.

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 6, 2023
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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