The Effects Of Cold Application To The Intact Side In Addition Cross Training With NMES On Dorsiflexor Muscle Strength In Hemiplegia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change of ankle dorsiflexor isometric muscle strength
研究概览
简要总结
The aim of this study is to investigate whether a cold application to the contralateral (affected side) extremity in addition to unilateral neuromuscular electrical stimulation (NMES) application has a facilitating effect on muscle strength in post-stroke hemiplegia patients.
详细描述
In this prospective randomized controlled single-blind study, a total of 25 patients, 16 men, and 9 women were included according to inclusion and exclusion criteria. Patients were randomly assigned to the experimental group (n=12) or the control group (n=13). NMES has applied to the non-affected side ankle dorsiflexors five sessions for a week in both groups. In addition to the experimental group, the cold application was applied on the affected side dorsiflexor muscle skin. The cold application was done on a moist towel for five minutes using a cold pack. A five-minute break was given and a further 5-minute cold application was repeated. The cold application was done simultaneously with NMES. A conventional rehabilitation program was applied to all patients by a physiotherapist. Before and after treatment, both ankle dorsiflexor strength was measured with a force sensor. For force measurements, a force transducer (FC2211-0000-0100-L Compression Load Cell, TE Connectivity company, France) was used. Force transducer signals were received with a data acquisition device (POWERLAB® data acquisition system ADInstruments, Oxford, UK) and evaluated offline on the computer. The measurement values were expressed in kilogram.force (kg.f) and this value was normalized according to body weight.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cases with stroke duration ≥1 month
- •Brunnstrom stage ≥4 for lower limb
- •Unilateral stroke
- •Ability to walk at least 10 m (FAC ≥3)
- •Cooperating with the examination and tests
排除标准
- •Cold allergy
- •Active inflammatory, rheumatological, or infectious disease
- •Presence of lower extremity fracture
- •Severe spasticity (MAS> 3) in ankle dorsiflexors
- •Peripheral nerve lesions such as polyneuropathy, radiculopathy
- •Parent rhythm/conduction block problem in the heart
- •Uncontrollable hypertension (Maxima >140 mmHg, Minima >90 mmHg)
- •Have a contracture on the ankle joint
- •The presence of skin lesions in the application area
- •Finding or suspected active deep vein thrombosis
结局指标
主要结局
Change of ankle dorsiflexor isometric muscle strength
时间窗: Change from Baseline ankle dorsiflexor isometric muscle strength at 6 days
Force transducer used for measuring maximum voluntary ankle dorsiflexion force. The force unit is kilogram.force
次要结局
- Change of Lower Extremity Brunnstrom Score(Change from Baseline Lower Extremity Brunnstrom Score at 6 days)
- Change of Modified Ashworth Scale Score(Change from Baseline Modified Ashworth Scale Score at 6 days)
- Change of Functional Ambulation Scale Score(Change from Baseline Functional Ambulation Scale Score at 6 days)
- Change of Timed Up and Go Test Score(Change from Baseline Change of Timed Up and Go Test Score at 6 days)