Effect of Thermal Stimulation for Lower Extremity Movement and Function in Patients With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- The change score from baseline to post-treatment and baseline to 1M follow-up in the lower-limb subscale of the Stroke Rehabilitation Assessment of Movement(LE-STREAM)
研究概览
简要总结
The thermal stimulation have been proven effective in upper extremity of stroke patients. Therefore, this study explored the efficacy of thermal stimulation in lower extremity of stroke patients.
详细描述
There are two groups of stroke patients (onset > 3 months) in this study. The independent factor is temperature of the alternated heat and cold applying.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusive criteria:
- •first-ever stroke
- •stroke onset > 3 months and < 3 years before the study enrollment
- •unilateral hemiplegia
- •ability to sit on a chair > 30 minutes independently
- •able to follow verbal instructions
- •age between 18 y/o and 80 y/o
- •be willing to participate in this study and gave their informed consent
- •The exclusive criteria:
- •skin disease, skin injuries, burns, or fresh scars over the TS application area
- •contraindication of ice or heat application
- •speech disorder or global aphasia
- •musculoskeletal or cardiac disorders that could potentially interfere
- •diabetic history or sensory impairment attributable to neuropathy.
排除标准
- 未提供
研究组 & 干预措施
noxious thermal stimulation
Heat-pain:46-47°C and Cold-pain:2-3°C alternately (intervention) 3 times /week and total 24 TS while conventional rehabilitation program was given
干预措施: thermal stimulation (Other)
thermal stimulation (innocuous)
Heat:40-41°C and Cold:23-24°C alternately (intervention) 3 times /week and total 24 TS while conventional rehabilitation program was given
干预措施: thermal stimulation (Other)
结局指标
主要结局
The change score from baseline to post-treatment and baseline to 1M follow-up in the lower-limb subscale of the Stroke Rehabilitation Assessment of Movement(LE-STREAM)
时间窗: pre, post, 1M follow-up
The lower-limb subscale of the Stroke Rehabilitation Assessment of Movement (LE-STREAM) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.
The change score from baseline to post-treatment and baseline to 1M follow-up in the mobility subscale of the Stroke Rehabilitation Assessment of Movement STREAM (Mob-STREAM)
时间窗: pre, post, 1M follow-up
The mobility subscale of the Stroke Rehabilitation Assessment of Movement STREAM (Mob-STREAM) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.
The change score from baseline to post-treatment and baseline to 1M follow-up in the Functional Ambulation Category (FAC)
时间窗: pre, post, 1M follow-up
Functional Ambulation Category (FAC) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.
The change score from baseline to post-treatment and baseline to 1M follow-up in the Barthel Index
时间窗: pre, post, 1M follow-up
Barthel Index (BI) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.
次要结局
- The change score from baseline to post-treatment and baseline to 1M follow-up in the Postural Assessment Scale for Stroke Patients (PASS)(pre, post, 1M follow-up)
- The change score from baseline to post-treatment and baseline to 1M follow-up in the Modified Ashworth Scale(pre, post, 1M follow-up)
研究者
Hsin-Wen Hsu
physical therapist (graduated student)
Kaohsiung Medical University Chung-Ho Memorial Hospital