A Randomized Controlled Trial of Rectus Femoris Tenotomy Versus Botulinum Toxin A for Stiff Knee Gait After Stroke
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Ashworth scale at the rectus femoris
研究概览
简要总结
Stiff knee gait is defined as the lack of knee flexion in the swing phase of gait. Stiff knee gait is a frequent condition among stroke patients leading to reduce gait speed and increase energy cost. In association with neuro-rehabilitation, botulinum toxin A injections in the rectus femoris is recommended. However, the botulinum toxin A effect is transient necessitating repeated injections.
The aim of this study is to compare the benefit of the rectus femoris tenotomy in comparison with botulinum toxin A injections according to the 3 domains of the International Classification of Functioning Disability and Health of the World Health Organisation
详细描述
INTRODUCTION
Stroke is the third cause of death and the leading cause of handicap among industrialized countries. Spasticity and co-contraction of the rectus femoris muscle following stroke is responsible for a lack of knee flexion in the swing phase of gait named stiff knee gait.
The rectus femoris spasticity is usually treated by oral medications, physical therapy and botulinum toxin A injections (1,2). As botulinum toxin A has a transient effect, injections must be repeated supporting to promote a permanent surgical treatment such as the rectus femoris tenotomy (3). However, no study has evaluate neither compare the effect of the rectus femoris tenotomy on gait and on the 3 domains of the International Classification of Functioning Disability and Health .
OBJECTIVE
To compare the effect of the rectus femoris tenotomy and of the botulinum toxin A injections for stiff knee gait after stroke according to the 3 domains of the International Classification of Functioning Disability and Health
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stroke lasting for more than 6 months
- •stiff knee gait
- •rectus femoris spasticity (> Ashworth 2)
- •transient improvement with previous botulinum toxine A injection in the rectus femoris
- •stiff knee gait improved after rectus femoris diagnostic motor nere block
- •able to walk on treadmill
排除标准
- •pregnant women
- •botulinum toxin A injections in the rectus femoris < 6 months
- •previous surgery for stiff knee gait
研究组 & 干预措施
Rectus femoris tenotomy
Surgical release of the proximal tendon of the rectus femoris
干预措施: Tenotomy of the proximal rectus femoris tendon (Procedure)
Botulinum toxin in the rectus femoris muscle
Botulinum toxin (200U Botox) injection in the rectus femoris muscle
干预措施: Botulinum Toxin injection in the rectus femoris muscle (Drug)
结局指标
主要结局
Ashworth scale at the rectus femoris
时间窗: 6 months
Spasticity assessment scale
次要结局
- Stroke impairment assessment set (SIAS(6 months)
- Tardieu scale(6 months)
- MRC (Medical research Council) scale(6 months)
- Isometric muscle strenght assessment(6 months)
- 10 meter walking test(6 months)
- Instrumented gait analysis(6 months)
- ABILOCO scale(6 months)
- EQ-5D-5L scale(6 months)
研究者
Deltombe Thierry
Professeur Clinique
University Hospital of Mont-Godinne