Multiple SclerosisNCT06159361
Balance Targeted Exercises for Individuals With MS
A study testing Balance targeted exercises in people with Multiple Sclerosis, run by University of Miami at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Balance targeted exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- MS-related exacerbation or medication change in the past two months.
- Presence of concurrent neurological or orthopedic disorders.
- Unable to perform the experimental tasks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Targeted Exercise Program on Balance and Postural Responses in Patients With Multiple Sclerosis (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
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).
- Conditions
- Multiple Sclerosis
- Being tested
- Balance targeted exercises
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance targeted exercisesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Balance targeted exercises group | Experimental | participants in this group will receive the balance targeted exercises for up to 6 weeks Receives: Behavioral: Balance targeted exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 weeks (post intervention)
Change in reaction time
Measure in seconds
Measured: Baseline, 6 weeks (post intervention)
Change in movement velocity
Measure in degree per second
Measured: Baseline, 6 weeks (post intervention)
Change in endpoint excursion percentage
measure of endpoint excursion in a percentage out of a100
Measured: Baseline, 6 weeks (post intervention)
Change in directional control percentage
measure of directional control in a percentage out of a100
Measured: Baseline, 6 weeks (post intervention)
Change in maximum excursion percentage
measure of maximum excursion in a percentage out of a100
Measured: 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.
Measured: Baseline, 6 weeks (post intervention)
Change in postural muscles responses latency as measured by Electromyography (EMG)
Postural muscles responses onset latency in seconds
Measured: Baseline, 6 weeks (post intervention)
Change in APA as measured by microvolts
Postural muscles APA measured in microvolts
Measured: Baseline, 6 weeks (post intervention)
Change in CPA as measured by microvolts
Postural muscles CPA in microvolts
Measured: Baseline, 6 weeks (post intervention)
Secondary outcomes (2)
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.
Measured: Baseline, 6 weeks (post intervention)
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
Measured: Baseline, 6 weeks (post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start6 Dec 2023
- Primary completion1 Sep 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Moore, University of Miami
- Investigators
- James Moore, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159361
- Sponsor's protocol ID
- 20231151
- Status last verified
- Jan 2025
- First submitted
- 28 Nov 2023
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Targeted Exercise Program on Balance and Postural Responses in Patients With Multiple Sclerosis (MS)
- ClinicalTrials.gov ID
- NCT06159361
- Acronym / sponsor ID
- 20231151
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Balance targeted exercises group | Experimental | Behavioral: Balance targeted exercisesparticipants in this group will receive the balance targeted exercises for up to 6 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- MS-related exacerbation or medication change in the past two months.
- Presence of concurrent neurological or orthopedic disorders.
- Unable to perform the experimental tasks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance targeted exercises6-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. | Behavioural | Balance targeted exercises group |
Primary outcome
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 reaction time
Time frame: Baseline, 6 weeks (post intervention)
Measure in seconds
Change in movement velocity
Time frame: Baseline, 6 weeks (post intervention)
Measure in degree per second
Change in endpoint excursion percentage
Time frame: Baseline, 6 weeks (post intervention)
measure of endpoint excursion in a percentage out of a100
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 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 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
Change in CPA as measured by microvolts
Time frame: Baseline, 6 weeks (post intervention)
Postural muscles CPA in microvolts
2 secondary outcomes
Change in balance confidence as measured by ABC
Time frame: Baseline, 6 weeks (post intervention)
Change in quality of life as measured by the MSQoL-54
Time frame: Baseline, 6 weeks (post intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Moore, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance targeted exercises in people with Multiple Sclerosis, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in balance ability as measured by the BESTest (time frame: Baseline, 6 weeks (post intervention)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.