The proposed study will answer the key question whether Botulinum toxin injection in the spastic (tight) lower limb muscles following stroke improves walking and the quality of life.

Phase 3

• Conditions: Stroke; Post stroke lower limb spasticity; Spasticity; Lower limb spasticity

• Registration Number: ACTRN12617001603303
• Lead Sponsor: The Hospital Research Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-07
• Last Update Posted: 19 November 2018

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gait velocity<br><br>The gait velocity will be measured in the Gait Rite (Electronic walkway) along with recording of other temporospatial gait parameters.<br><br>[3 weeks];2 Minutes Walking Distance[3 weeks]

Secondary Outcome Measures

Name	Time	Method
Quality of Life (SF 12)[Baseline assessment<br>3 weeks<br>3 months <br>5 months];Timed Up and Go[Baseline assessment<br>3 weeks<br>3 months <br>5 months];Berg Balance Score[Baseline assessment<br>3 weeks<br>3 months <br>5 months];Goal Attainment Scale (GAS)[Baseline assessment<br>3 weeks<br>3 months <br>5 months]