Clinical trial NCT06412003: Home-based Balance Training in Adults With Multiple Sclerosis
Official title: Home-based Balance Training With Family Member Support in Adults With Multiple Sclerosis: A Feasibility Single-group Pretest-posttest Design
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Multiple Sclerosis, MS
Keywords: balance training
Home-based exercise
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Feasibility outcome: Process
timeFrame: From enrollment to completion of posttest (12weeks)
measure: Feasibility outcome: Resources
timeFrame: From enrollment to completion of posttest (12weeks)
measure: Feasibility outcome: Management
timeFrame: From enrollment to completion of posttest (12weeks)
measure: Feasibility outcome: Participant burden/satisfaction
timeFrame: After completion of posttest (12weeks)
measure: Feasibility outcome: Adverse event
timeFrame: From enrollment to completion of posttest (12weeks)
measure: Feasibility outcome: Intervention acceptability
timeFrame: From enrollment to completion of posttest (12weeks)
measure: Feasibility outcome: exercise intensity acceptability/compliance
timeFrame: From enrollment to completion of posttest (12weeks)
Secondary outcomes:
measure: Changes in balance as measured by Timed Up and Go/Dual-task Timed Up and Go
timeFrame: Baseline and after completion of an intervention (12weeks)
measure: Changes in functional mobility as measured by 5-time sit-to-stand
timeFrame: Baseline and after completion of an intervention (12weeks)
measure: Changes in static balance as measured by4-stage static balance tests
timeFrame: Baseline and after completion of an intervention (12weeks)
measure: Changes in cognitive function as measured by Brief International Cognitive Assessments for MS (BICAMS)
timeFrame: Baseline and after completion of an intervention (12weeks)
measure: Changes in community mobility perception as measured by Environmental Analysis of Mobility Questionnaire (EAMQ)
timeFrame: Baseline and after completion of an intervention (12weeks)
measure: Changes in fear of falling as measured by Fall Efficacy Scale-International (FES-I)
timeFrame: Baseline and after completion of an intervention (12weeks)
measure: Changes in self-reported walking disability as measured by Multiple Sclerosis Walking Scale-12v2 (MSWS-12v2)
timeFrame: Baseline and after completion of an intervention (12weeks)
measure: Changes in self-reported dual-tasking difficulty as measured by Dual-task Impact on Daily-Living Activities Questionnaire (DIDA-Q)
timeFrame: Baseline and after completion of an intervention (12weeks)
measure: Changes in self-reported fatigue as measured by Fatigue Scale for Motor and Cognitive Functions (FSMC)
timeFrame: Baseline and after completion of an intervention (12weeks)
measure: Changes in Real-world ambulation metrics as measured by tri-axial accelerometer
timeFrame: Baseline and after completion of an intervention (12weeks)
measure: Changes in exercise intention
timeFrame: Baseline and after completion of an intervention (12weeks)
Other outcomes:
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