CTRI/2024/11/077262尚未招募不适用
Comparative study on improvement in gait between between 6% phenol chemoneurolysis and onabotulinum toxin type A in post stroke spasticity
IPGMER AND SSKM HOSPITAL1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年12月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Improvement in modified ashworth scale , step length, cadence, gait speed, stance phase, swing phase
研究概览
简要总结
To asses any improvement in Gait assessment parameters, Modified
Ashworth Scale before and after application of Phenol 6% injection to
Posterior tibial nerve/ branches
• To asses any improvement in Gait assessment parameters, Modified
Ashworth Scale before and after application of Onabotulinum Toxin A in
Gastrocnemius /Tibialis posterior muscle.
• To compare improvement in both these groups using Gait
assessment parameters, step length, cadence, gait speed, swing phase, stance phase, MAS
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically and radiologically diagnosed first ever stroke
- •Age of the patient 20-65 (19) years irrespective of gender.
- •3 months after onset of stroke
- •Spasticity at resting state of Gastrocnemius, soleus, tibialis posterior muscle as defined by MAS scale of 2/
- •Brunnstrom recovery stage III-IV
- •MMSE score ≥ 25
- •Consent from the patient.
排除标准
- •Other neurological disorder 2.Sensory impairment
- •Osteoarticular disease
- •Past H/O Botox or Phenol injection.
- •MAS ≤1 + , Adductor muscle spasticity
- •Local site infection 7.No contracture of lower limb or previous surgery for spasticity contracture.
- •Allergy to botulinum toxin type A or Phenol
- •Abnormal coagulation profile 10.Patients suffering from unstable cardio vascular or serious respiratory diseases
- •Pregnancy or breastfeeding.
结局指标
主要结局
Improvement in modified ashworth scale , step length, cadence, gait speed, stance phase, swing phase
时间窗: Pre procedure, 24 hours, 3 weeks , 12 weeks
次要结局
- Improvement in modified ashworth scale , step length, cadence, gait speed, stance phase, swing phase(pre procedure, Day 3, 12 weeks)
研究者
SHEEZAN PERWEZ
IPGMER AND SSKM
研究点 (1)
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