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Multiple SclerosisNCT06412003

Home-based Balance Training in Adults With Multiple Sclerosis

A study testing Home-based balance training in people with Multiple Sclerosis and Multiple Sclerosis, MS, run by University of Vermont.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This single-group pretest-posttest study aims to examine the feasibility domains in response to 12 weeks of home-based balance training in persons with multiple sclerosis (MS). The feasibility domains include 1) process (e.g., recruitment, attendance, adherence rate), 2) resources (e.g., total monetary costs), 3)… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Multiple Sclerosis, Multiple Sclerosis, MS
What is being tested?
Home-based balance training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
1 Jul 2024to 31 May 2025
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Physician-diagnosed MS
  • Ages 18-75 years
  • Patient Determined Disease Steps (PDDS) scale score between 2-5 (i.e., gait disability-late cane)
  • Able to participate in exercise (i.e., one or fewer affirmatives on the Physical Activity Readiness Questionnaire (PAR-Q+))
  • Have a webcam on a device at least the size of a full tablet (i.e., larger than a smartphone)
  • Have an exercise supporter (e.g., spouse or family member) who is willing to participate in the intervention
  • Not currently participating in any balance-related exercise program

Who cannot join

  • Cognitively unable to read and sign informed consent form and follow verbally delivered screening assessment
  • Unable to communicate in English

Trial locations and contacts

No sites are listed yet.

Myeongjin Bae, MS contact

8028295351

myeongjin.bae@uvm.edu

Susan Kasser, PhD contact

susan.kasser@med.uvm.edu

About this study

Official title: Home-based Balance Training With Family Member Support in Adults With Multiple Sclerosis: A Feasibility Single-group Pretest-posttest Design

This single-group pretest-posttest study aims to examine the feasibility domains in response to 12 weeks of home-based balance training in persons with multiple sclerosis (MS). The feasibility domains include 1) process (e.g., recruitment, attendance, adherence rate), 2) resources (e.g., total monetary costs), 3) management (e.g., assessment time), and 4) scientific outcomes (adverse events, intervention acceptability, satisfaction, treatment effects). Moreover, this study aims to evaluate physical function (i.e., balance, mobility, dual-task ability), cognitive function (i.e., cognitive processing speed, verbal memory, visuospatial memory), real-world ambulation (i.e., gait speed, gait variability, gait quantity), and self-report questionnaires (fatigue, fear of falling, walking disability, dual-tasking difficulty). Our proposed intervention is expected to deliver a feasible and accessible exercise modality for balance and cognitive improvement in persons with multiple sclerosis.

Read the detailed description

Acknowledging the complex system of balance, this home-based balance training aims to address comprehensive balance control components, such as static balance, limit of stability, postural response (reactive balance), anticipatory postural transition, weight shifting, stability in gait, and stepping exercise. These balance components will be encompassed in every session to train balance function comprehensively. Exercise program will be progressed by varying sensory integrations, base of support, and simultaneous motor-cognitive tasks (i.e., dual-task).

Being tested
Home-based balance training
Keywords
balance training, Home-based exercise
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home-based balance trainingBehavioural

    This is a family member supported home-based balance training program designed for community-dwelling people with MS to improve balance and walking abilities as well as cognitive functions. The intervention program aims to have participants with MS reach high-intensity balance tasks during the program. A bi-weekly two-on-one, semi-structured, video-chat session with participants and their exercise supporter and research team will be conducted using videoconferencing techniques (e.g., Zoom, Skype, or Facetime).

Study groups in NCT06412003
Study groupRoleWhat they receive
Home-based balance training groupExperimentalParticipants will perform the home-based balance training program for 30-40 minutes per session, 3 days per week for 12 weeks not including the two weeks of education and familiarization.
Receives: Behavioral: Home-based balance training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility outcome: Process

    This study will assess 1) recruitment rate (the number of participants screened divided by the total number of participants contacted), 2) eligibility rate (the number of participants eligible divided by total number of participants screened), 3) adherence rate (the percentages of withdrawals and completions), and 4) attendance rate (the percentages of targeted exercise sessions completed by intervention group participants who completed the study). These 4 rates will be employed to assess the feasibility of process.

    Measured: From enrollment to completion of posttest (12weeks)

  2. Feasibility outcome: Resources

    The total expenses of the study will be calculated, including materials (e.g., exercise equipment) and participant remuneration.

    Measured: From enrollment to completion of posttest (12weeks)

  3. Feasibility outcome: Management

    This study will document all videoconferencing time and baseline and follow-up assessment time. The measures will assess the time management of the intervention.

    Measured: From enrollment to completion of posttest (12weeks)

  4. Feasibility outcome: Participant burden/satisfaction

    This study will assess participant burden and satisfaction through a questionnaire after the completion of the intervention. The questionnaire consists of 12 closed-ended and 2 open-ended items

    Measured: After completion of posttest (12weeks)

  5. Feasibility outcome: Adverse event

    This study will record adverse event occurred during the intervention program.

    Measured: From enrollment to completion of posttest (12weeks)

  6. Feasibility outcome: Intervention acceptability

    This study will assess whether participants meet the prescribed exercise doses throughout the intervention program.

    Measured: From enrollment to completion of posttest (12weeks)

  7. Feasibility outcome: exercise intensity acceptability/compliance

    This study will assess whether participants adhere to a prescribed exercise intensity dose throughout the intervention program. An exercise log will be employed to assess exercise intensity acceptability.

    Measured: From enrollment to completion of posttest (12weeks)

Secondary outcomes (11)

  1. Changes in balance as measured by Timed Up and Go/Dual-task Timed Up and Go

    The Timed Up and Go test assesses mobility, anticipatory postural control, and dynamic balance. Dual-task Timed Up and Go will assess cognitive-motor interference

    Measured: Baseline and after completion of an intervention (12weeks)

  2. Changes in functional mobility as measured by 5-time sit-to-stand

    The test is a valid measure of functional mobility and dynamic balance performance in people with multiple sclerosis.

    Measured: Baseline and after completion of an intervention (12weeks)

  3. Changes in static balance as measured by4-stage static balance tests

    The test assesses static balance ability in participants with multiple sclerosis.

    Measured: Baseline and after completion of an intervention (12weeks)

  4. Changes in cognitive function as measured by Brief International Cognitive Assessments for MS (BICAMS)

    This neuropsychological cognitive test battery is a valid measure for persons with multiple sclerosis. The BICAMS includes Symbol Digit Modalities Test (SDMT), California Verbal Learning Test (CVLT2), and revised Brief Visuospatial Memory Test (BVMTR), whose tests primarily target to measure cognitive processing speed, verbal memory, and visuospatial memory, respectively.

    Measured: Baseline and after completion of an intervention (12weeks)

  5. Changes in community mobility perception as measured by Environmental Analysis of Mobility Questionnaire (EAMQ)

    This study will assess perceptions of community mobility in relation to specific environmental situations or tasks using the Environmental Analysis of Mobility Questionnaire (EAMQ). EAMQ consists of 24 items grouped within 8 environmental dimensions: distance, temporal, ambient, terrain, physical load, postural transition, attention, and density. Participants will be asked to rate the frequency of avoidance of specific mobility tasks on a 5-point scale ranging from 1 (never avoid) to 5 (always avoid). Total scores for each dimension will be calculated and assessed in the analyses.

    Measured: Baseline and after completion of an intervention (12weeks)

  6. Changes in fear of falling as measured by Fall Efficacy Scale-International (FES-I)

    This survey assesses how concerned one is about falling during both physical and social activities. Participants will be asked to rate 16 items using a 4-point Likert-type scale (1=not at all concerned, 4=very concerned), with lower scores indicating less concern about falling.

    Measured: Baseline and after completion of an intervention (12weeks)

  7. Changes in self-reported walking disability as measured by Multiple Sclerosis Walking Scale-12v2 (MSWS-12v2)

    The Multiple Sclerosis Walking Scale-12v2 (MSWS-12v2) will assess perceived limitations to their walking under varying conditions. The survey includes 12 items, of which three items are rated on a 3-point scale (1= not at all, 2=sometime, 3=a lot) and nine items by a 5-point scale (1=not limited, 5=extremely limited). Total scores range from 12 to 54, with higher scores indicating greater perceived mobility impairment.

    Measured: Baseline and after completion of an intervention (12weeks)

  8. Changes in self-reported dual-tasking difficulty as measured by Dual-task Impact on Daily-Living Activities Questionnaire (DIDA-Q)

    The Dual-task Impact on Daily-Living Activities Questionnaire (DIDA-Q) contains 16 items rated on 5-point Likert-type scale (0=no difficulty, 4=extremely difficult). A total score ranges from 0 to 76, with higher scores demonstrating greater difficulty in dual-tasking.

    Measured: Baseline and after completion of an intervention (12weeks)

  9. Changes in self-reported fatigue as measured by Fatigue Scale for Motor and Cognitive Functions (FSMC)

    This survey consists of 20 items, including 10 items for motor fatigue and 10 items for cognitive fatigue, with scales ranging from 1 (i.e., does not apply at all) to 5 (i.e., applies completely). Higher score indicates greater level of fatigue.

    Measured: Baseline and after completion of an intervention (12weeks)

  10. Changes in Real-world ambulation metrics as measured by tri-axial accelerometer

    The AX3 3-axis accelerometer (Axivity, York, UK) will be employed to collect real-world ambulation, including gait speed and stride regularity.

    Measured: Baseline and after completion of an intervention (12weeks)

  11. Changes in exercise intention

    The questionnaire will assess exercise supporters' attitudes, perceived behavioral control, and intentions by a constructed questionnaire based on the theory of planned behavior. The questionnaire includes 61 items, with a higher score indicating greater exercise support attitudes, perceived behavioral control, and intentions

    Measured: Baseline and after completion of an intervention (12weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2024
  2. Study start1 Jul 2024 (estimated)
  3. Primary completion31 Mar 2025 (estimated)
  4. Study completion31 May 2025 (estimated)

Resources

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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06412003
Sponsor's protocol ID
STUDY00002956
Status last verified
May 2024
First submitted
6 May 2024
Last updated
16 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bae M, Gell NM, Ramsey C, Kasser SL. Feasibility of home-based high-intensity balance training in persons with multiple sclerosis: A pretest-posttest study. Clin Rehabil. 2026 Jan;40(1):30-43. doi: 10.1177/02692155251384079. Epub 2025 Oct 17.

    PubMed 41105745

Questions about this trial

What is this clinical trial studying?

A study testing Home-based balance training in people with Multiple Sclerosis and Multiple Sclerosis, MS, run by University of Vermont.

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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Myeongjin Bae, MS (8028295351, myeongjin.bae@uvm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility outcome: Process (time frame: From enrollment to completion of posttest (12weeks)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06412003, which also lists 1 linked publication.

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 16 May 2024.

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