Home-based Balance Training in Adults With Multiple Sclerosis

NCT ID: NCT06412003

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-05-31

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.

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).

Conditions

Multiple Sclerosis; Multiple Sclerosis, MS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Home-based balance training group

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.

Group Type: EXPERIMENTAL

Home-based balance training

Intervention Type: 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).

Interventions

Home-based balance training

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Myeongjin Bae

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Myeongjin Bae, MS

Role: CONTACT

myeongjin.bae@uvm.edu

8028295351

Susan Kasser, PhD

Role: CONTACT

susan.kasser@med.uvm.edu

References

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. 2025 Oct 17:2692155251384079. doi: 10.1177/02692155251384079. Online ahead of print.

Reference Type: DERIVED

PMID: 41105745 (View on PubMed)

Other Identifiers

STUDY00002956

Identifier Type: -

Identifier Source: org_study_id