Home-based Balance Training in Adults With Multiple Sclerosis

NCT06412003 | Not Yet Recruiting

• 1 other identifier: STUDY00002956
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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) 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.

Conditions

Multiple Sclerosis; Multiple Sclerosis, MS

Keywords

balance training; Home-based exercise

Outcome Measures

Primary Outcomes (7)

• 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.

  From enrollment to completion of posttest (12weeks)

• Feasibility outcome: Resources

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

  From enrollment to completion of posttest (12weeks)

• 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.

  From enrollment to completion of posttest (12weeks)

• 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

  After completion of posttest (12weeks)

• Feasibility outcome: Adverse event

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

  From enrollment to completion of posttest (12weeks)

• Feasibility outcome: Intervention acceptability

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

  From enrollment to completion of posttest (12weeks)

• 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.

  From enrollment to completion of posttest (12weeks)

Secondary Outcomes (11)

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

  Baseline and after completion of an intervention (12weeks)

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

  Baseline and after completion of an intervention (12weeks)

• Changes in static balance as measured by4-stage static balance tests

  Baseline and after completion of an intervention (12weeks)

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

  Baseline and after completion of an intervention (12weeks)

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

  Baseline and after completion of an intervention (12weeks)

Study Arms (1)

Home-based balance training group

EXPERIMENTAL

Participants 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.

Behavioral: Home-based balance training

Interventions

Home-based balance training BEHAVIORAL

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).

Home-based balance training group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Vermont: lead

Related Publications (1)

• 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.

  PMID: 41105745 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Myeongjin Bae, MS

CONTACT

8028295351; myeongjin.bae@uvm.edu

Susan Kasser, PhD

CONTACT

susan.kasser@med.uvm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 14, 2024
• Study Start: July 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: May 31, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05