Effects of Isokinetic Strength Training of Knee Flexor and Extensor Muscles on Walking in Hemiparetic Patients With Knee Extension Thrust
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- spontaneous walking speed
研究概览
简要总结
The purpose of this study is to assess the impact of an isokinetic strength training of knee flexor and extensor muscles on walking performance in hemiparetic patients with knee extension thrust.
详细描述
The study will be interventional single case experimental design (SCED) with multiple baseline design. SCED are experimental designs aiming at testing the effect of an intervention using a small number of patients using repeated measurements, sequential and randomized introduction of an intervention and method-specific data analysis, including visual analysis and specific statistics.
During baseline, patients will have a rehabilitation program in day hospital (4 days per week) with physiotherapy and physical activity and if necessary occupational and speech therapy. Isokinetic strength training will be added to this conventionnal rehabilitation program and will begin after 3, 4 or 5 weeks of baseline according to randomization
12 patients will be included in this study (6 patients in subacute stage and 6 in chronic stage ).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the intervention neither subjects nor staff can be blinded to allocation. The outcome assessors and data analyst will be blinded to research aims and randomization (multiple baseline design before introducing isokinetic strength training)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemiparetic patient (hemorragic or ischemic stroke)
- •Subacute stage (< 6 Months) ou chronic stage of stroke (> 6 months) (6 patients in each group)
- •Age between 18 and 75 years
- •Able to walk 10 meters independently without any assistive devices
- •Knee extension thrust during stance phase of gait cycle (rapid posterior movement of the knee toward extension)
- •Scheduled rehabilitation program with isokinetic strength training
- •affiliation to a social security
- •Patients who received and signed informed consent
排除标准
- •Major comprehension deficit that not allow to give informed consent and participate to isokinetic strength training (assessed with comprehension subscore of Langague screening Test)
- •non stable (unstable cardiovascular condition)
- •musculoskeletal disorders with knee pain that not allowed isokinetic strength training
- •Botulinum toxin injection less than 3 months or repeated injection in lower limb,
- •Proprioception trouble assessed with proprioception section of the Fugl-Meyer Assessment [FMA-P] 0/2
- •spasticity of triceps surae ≥2 (Modified Ashworth scale)
- •ankle dorsiflexion angle less than 90°
- •pregnant women or breastfeeding
- •persons with safety measure
结局指标
主要结局
spontaneous walking speed
时间窗: 25 weeks
Spontaneous walking speed of hemiparetic patients recorded with 3D gait analysis
次要结局
- 6-minute walk test(25 weeks)
- Extensor thrust analysis(25 weeks)
- Walking speed(25 weeks)
- Stairs test(25 weeks)
- Inclined plan(25 weeks)
- Extensor thrust during locomotor tasks(25 weeks)
- Sit to stand test(25 weeks)
- Fatigue(25 weeks)
- Likert Scale(25 weeks)
- Strength(25 weeks)