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CompletedNCT06159361Updated Jan 31, 2025

Balance Targeted Exercises for Individuals With MS

An interventional study of Balance targeted exercises in Multiple Sclerosis, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-01-31.

Sponsored by University of Miami · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
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Study 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

Read the 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).

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Conditions studied

  • Multiple Sclerosis
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In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 7 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    Balance targeted exercises group

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

    Behavioral: Balance targeted exercises

Interventions

  • BehavioralBalance 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 6 weeks (post intervention)

  2. Change in reaction time

    Measure in seconds

    Time frame: Baseline, 6 weeks (post intervention)

  3. Change in movement velocity

    Measure in degree per second

    Time frame: Baseline, 6 weeks (post intervention)

  4. Change in endpoint excursion percentage

    measure of endpoint excursion in a percentage out of a100

    Time frame: Baseline, 6 weeks (post intervention)

  5. Change in directional control percentage

    measure of directional control in a percentage out of a100

    Time frame: Baseline, 6 weeks (post intervention)

  6. Change in maximum excursion percentage

    measure of maximum excursion in a percentage out of a100

    Time frame: Baseline, 6 weeks (post intervention)

  7. 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.

    Time frame: Baseline, 6 weeks (post intervention)

  8. Change in postural muscles responses latency as measured by Electromyography (EMG)

    Postural muscles responses onset latency in seconds

    Time frame: Baseline, 6 weeks (post intervention)

  9. Change in APA as measured by microvolts

    Postural muscles APA measured in microvolts

    Time frame: Baseline, 6 weeks (post intervention)

  10. Change in CPA as measured by microvolts

    Postural muscles CPA in microvolts

    Time frame: Baseline, 6 weeks (post intervention)

Secondary outcomes

  1. 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.

    Time frame: Baseline, 6 weeks (post intervention)

  2. 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

    Time frame: Baseline, 6 weeks (post intervention)

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Study locations

1 site
  • University of Miami
    Miami, Florida 33136, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06159361
Lead sponsor
University of Miami
Responsible party
James Moore (Associate professor of clinical, University of Miami) — Principal investigator
First posted
Dec 6, 2023
Start date
Dec 6, 2023
Primary completion
Sep 1, 2024
Completion
Dec 30, 2024
Last update
Jan 31, 2025

Study contacts

James Moore, PhD
principal investigator · University of Miami

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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