Interface Pressures, Safety, Adherence, and Tactile Outcomes of Different Pressure Garments After Stroke: A Prospective, Participant-Blinded, Three-Arm, Parallel-Group Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 33
- 主要终点
- Interface pressure measured using PicoPress® Compression System
研究概览
简要总结
This study aims to investigate the interface pressure changes of single-layer with 10% circumferential reduction (S-10), single-layer with 15% circumferential reduction (S-15), and dorsal double-layered with 10% circumferential reduction (DD-10)pressure garments over time, their relationships with adherence and adverse events, and their effects on tactile gnosis.
Participants will:
- Wear S-10, S-15, or DD-10 for at least 12 hours daily for four weeks
- Measure interface pressure at baseline and weekly
- Assess tactile gnosis at baseline, Week 2, and Week 4
- Record adherence and adverse events using a self-report logbook
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults aged between 21 years to 60 years old
- •a history of stroke (no restrictions on the stroke type)
- •Modified Ashworth Scale of 1, 1+ or 2 when hand performing flexion and extension
- •no cognitive impairment (Montreal Cognitive Assessment (MoCA ⩾ 21)
排除标准
- •skin lesions, infections or other skin problems
- •serious circulatory problems such as deep vein thrombosis
- •hypersensitive to Lycra materials
- •behavioural disturbances or motor impairments caused by other orthopaedic or neurological conditions other than stroke
结局指标
主要结局
Interface pressure measured using PicoPress® Compression System
时间窗: Baseline, Week-1, Week-2, Week-3, and Week-4
The change in interface pressure over time and the group-by-time difference in pressure trajectories among the three pressure garment groups. PicoPress® Compression System is a portable pneumatic measuring system designed to measure interface pressure exerted by pressure garment, medical compression bandage or other compression therapeutic materials.
次要结局
- Shape/Texture Identification (STI) test(Baseline, Week-2, and Week-4)
- Daily Self-Report and Adverse Events of Special Interest (AESI) Logbook(Completed by participants or caregiver daily, reviewed weekly by researcher)
- Modified Ashworth Score (MAS)(Baseline, Week-1, Week-2, Week-3, and Week-4)