Home-based Balance Training With Family Member Support in Adults With Multiple Sclerosis: A Feasibility Single-group Pretest-posttest Design
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Feasibility outcome: Resources
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Cognitively unable to read and sign informed consent form and follow verbally delivered screening assessment
- •Unable to communicate in English
结局指标
主要结局
Feasibility outcome: Resources
时间窗: From enrollment to completion of posttest (12weeks)
The total expenses of the study will be calculated, including materials (e.g., exercise equipment) and participant remuneration.
Feasibility outcome: exercise intensity acceptability/compliance
时间窗: From enrollment to completion of posttest (12weeks)
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.
Feasibility outcome: Management
时间窗: From enrollment to completion of posttest (12weeks)
This study will document all videoconferencing time and baseline and follow-up assessment time. The measures will assess the time management of the intervention.
Feasibility outcome: Adverse event
时间窗: From enrollment to completion of posttest (12weeks)
This study will record adverse event occurred during the intervention program.
Feasibility outcome: Process
时间窗: From enrollment to completion of posttest (12weeks)
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.
Feasibility outcome: Participant burden/satisfaction
时间窗: After completion of posttest (12weeks)
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
Feasibility outcome: Intervention acceptability
时间窗: From enrollment to completion of posttest (12weeks)
This study will assess whether participants meet the prescribed exercise doses throughout the intervention program.
次要结局
- Changes in static balance as measured by4-stage static balance tests(Baseline and after completion of an intervention (12weeks))
- Changes in self-reported walking disability as measured by Multiple Sclerosis Walking Scale-12v2 (MSWS-12v2)(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)(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))
- Changes in fear of falling as measured by Fall Efficacy Scale-International (FES-I)(Baseline and after completion of an intervention (12weeks))
- Changes in Real-world ambulation metrics as measured by tri-axial accelerometer(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 balance as measured by Timed Up and Go/Dual-task Timed Up and Go(Baseline and after completion of an intervention (12weeks))
- Changes in self-reported fatigue as measured by Fatigue Scale for Motor and Cognitive Functions (FSMC)(Baseline and after completion of an intervention (12weeks))
- Changes in exercise intention(Baseline and after completion of an intervention (12weeks))
研究者
Myeongjin Bae
Principal Investigator
University of Vermont