Effect of Air Splints on Sensoriomotor Disturbances of the Affected Upper Extremity and Trunk Control in the Adult Post-stroke Patient: A Pilot Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in upper limb sensorimotor function measured by the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE)
研究概览
简要总结
Objective: Sensory impairment in the affected upper limb occurs in approximately 50% of post-stroke patients and negatively impacts functional capacity and quality of life. This pilot study aims to evaluate whether the standardized use of pneumatic (air) splints, as part of a neurodevelopmental treatment approach, will have a positive effect on sensorimotor deficits in the hemiplegic upper limb of post-stroke patients.
Design: Pilot randomized, single-blind clinical trial.
Setting: Brain injury rehabilitation facility.
Participants: Twenty adults in the subacute phase after stroke will be randomized into two groups. The experimental group (n = 10) will receive air splint therapy combined with physiotherapy (45 minutes per session, twice per week for 4 weeks). The control group (n = 10) will receive only physiotherapy with the same duration and frequency. Sensorimotor outcomes will be assessed using the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE), and finger flexor/extensor strength will be measured using the Amadeo robotic system. Assessments will be conducted before and after the intervention.
Conclusions: The addition of air splints to physiotherapy may enhance exteroceptive and proprioceptive sensitivity in adults recovering from stroke during the subacute phase.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stroke at least 2 months earlier
- •Mild/moderate hypertonia (Ashworth ≤3)
- •Proprioceptive and exteroceptive deficits
- •Trunk stability score between 8-23 (TCT)
排除标准
- •Non-vascular etiology
- •Clinical instability
- •Skin lesions or deformities
- •Botulinum toxin in last 3 months
- •Cognitive/communication limitations
- •Maximum TCT score (23) at baseline
研究组 & 干预措施
Application of CPPS (Urias splints) + physiotherapy Intervention Type: Device
干预措施: Air splints (Device)
Physiotherapy alone following neurodevelopmental approach
结局指标
主要结局
Change in upper limb sensorimotor function measured by the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE)
时间窗: Baseline and post 4-week intervention
Change in upper limb sensorimotor function measured by the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE), a validated stroke-specific scale. The FMA-UE ranges from 0 to 66, where higher scores indicate better motor and sensory function.
次要结局
- Change in trunk function measured by the Trunk Control Test (TCT)(Baseline and after 4-week intervention)
- Change in balance performance measured by the Mini-Balance Evaluation Systems Test (Mini-BESTest)(Baseline and after 4-week intervention)
- Change in hand strength (flexion and extension) measured using the AMADEO robotic system.(Baseline and after 4-week intervention)
- Change in range of motion (ROM) of the shoulder and fingers measured using the AMADEO robotic system.(Baseline and after 4-week intervention)
研究者
Alicia Hernando Rosado
Physiotherapist (PhD)
Alfonso X El Sabio University