Efficacy of Botulinum Toxin A on Walking and Quality of Life in Post-Stroke Lower Limb Spasticity- a randomized double-blind placebo controlled Study

The Hospital Research Foundation0 个研究点目标入组 80 人开始时间: 2017年12月7日最近更新: 2018年11月19日

适应症

试验速览

暂无简介。

•Male or female subjects aged 20 to 80 years of age are eligible for this study if they had a stroke resulting in focal spasticity in the knee causing stiff knee and/or equinovarus deformity, as demonstrated by a score of more than 3 for quadriceps (rectus femoris), gastrocnemius, soleus, tibialis posterior, flexor hallucis longus or flexor digitorum longus on the Modified Ashworth Scale.
•All patients should be walking normally prior to stroke. Any patients with lower limb spasticity (MAS 3+) resulting in a limp, or any difficulty in weight bearing on the leg or walking such as reduced speed of gait following stroke will be included.

•This study will exclude patients with significant speech or cognitive impairment
•Significant lower limb problems such as fracture or arthritis, evidence of fixed
•contracture
•Use of botulinum toxin type A in the previous six months, other non-stroke
•neurological disorders causing lower limb spasticity
•Significant illness, such as malignancy, or contraindication to botulinum toxin type A,
•will exclude people from the study.
•Pregnant and lactating mothers will also be excluded from the study.
•Individuals with osteoarthritic knee or hip having pain score of 3/10 or more on VISUAL
•Analog Scale will be excluded.
•Individuals with significant depression (Geriatric Depression Scale (12 or more/15) and
•Beck Depression Inventory (30 or more/63) will be excluded from the study.
•Individuals on antispasticity medications such as Baclofen, Tizanidine, Dantrolene,
•Diazepam will be excluded from the study.

发起方

The Hospital Research Foundation