NCT07376772招募中不适用
Feasibility, Preliminary Efficacy, and User Perspective Usability of Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Nine-Hole Peg Test (9HPT)
研究概览
简要总结
This pilot mixed-method study will evaluate the feasibility, preliminary efficacy, and user experience of a home-based wearable Focal Vibration Therapy (FVT) intervention for improving upper extremity (UEx) function in people with multiple sclerosis (MS). Fifteen adults with relapsing-remitting MS (PRMS) and self-reported UEx impairments will participate in a 4-week FVT program using MyovoltTM wearable FVT devices applied to arm muscles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged over 18 years
- •Confirmed diagnosis of RRMS according to the McDonald criteria (33)
- •No MS relapse or exacerbation within the past 6 months (ensuring stability of symptoms)
- •Self-report on clinical evidence of UEx impairment (including reduced arm/hand function, muscle weakness, spasticity, or pain).
- •Stable on MS treatment for at least four weeks before recruitment, with no plans to initiate new treatments (participants may continue current treatments during the study)
- •Agree and are able to use the FVT device after training.
- •Sufficient proficiency in English to participate in interviews and follow instructions
- •Able to visit the laboratory for assessments
- •Able to provide written informed consent
排除标准
- •Evidence of cognitive impairment that could interfere with following instructions (Mini-Montreal Cognitive Assessment score (Mini-MoCA) < 12)
- •Comorbid neurological or psychiatric conditions affecting the UEx (including stroke and severe carpal tunnel syndrome) that would confound results or make FVT unsafe
- •Unstable cardiac disease or any major medical illness that would preclude participation
- •Any known contraindications to vibration therapy (pregnancy, acute deep vein thrombosis, severe osteoporosis, chronic migraines, epilepsy, active malignancy in the target area, unstable cardiac disease, or an implanted pacemaker without clearance)
研究组 & 干预措施
Intervention group
Experimental
Participants who will recieve the focal vibration therapy
干预措施: wearable focal vibration therapy (Device)
结局指标
主要结局
Nine-Hole Peg Test (9HPT)
时间窗: Baseline, week 4, week 8
The Nine-Hole Peg Test (9HPT) assesses fine motor coordination and dexterity by timing how quickly participants can place and remove nine pegs from a pegboard using one hand.
次要结局
- Arm Function in Multiple Sclerosis Questionnaire (AMSQ)(Baseline, week 4, week 8)
- Box and Block Test (BBT)(Baseline, week 4, week 8)
- Muscle Strength(Baseline, week 4, week 8)
- Modified Ashworth Scale (MAS)(Baseline, week 4, week 8)
- Visual Analog Scale (VAS) of Pain(Baseline, week 4, week 8)
- Modified Fatigue Impact Scale (MFIS)(Baseline, week 4, week 8)
- Usability(week 4, week 8)
- Adherence(week 4)
- Retention rate(baseline, week 4, week 8)
- Adverse events(week 4, week 8)
研究者
研究点 (2)
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