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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: After completion of posttest (12weeks)
Feasibility outcome: Adverse event
This study will record adverse event occurred during the intervention program.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to completion of posttest (12weeks)
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
Time frame: Baseline and after completion of an intervention (12weeks)
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.
Time frame: Baseline and after completion of an intervention (12weeks)
Changes in static balance as measured by4-stage static balance tests
The test assesses static balance ability in participants with multiple sclerosis.
Time frame: Baseline and after completion of an intervention (12weeks)
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.
Time frame: Baseline and after completion of an intervention (12weeks)
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.
Time frame: Baseline and after completion of an intervention (12weeks)
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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.
Time frame: Baseline and after completion of an intervention (12weeks)
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.
Time frame: Baseline and after completion of an intervention (12weeks)
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.
Time frame: Baseline and after completion of an intervention (12weeks)
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.
Time frame: Baseline and after completion of an intervention (12weeks)
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.
Time frame: Baseline and after completion of an intervention (12weeks)
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
Time frame: Baseline and after completion of an intervention (12weeks)