None listed
Conditions
Brief summary
The proposed research project will answer the key question whether Botulinum toxin injection in post stroke lower limb spasticity improves walking and other functional activities, and quality of life. In addition to injections of the toxin/placebo people, the participants who have had a stroke will also participate in a structured physiotherapy program and a home exercise program (standard care). The research project is designed to show whether, following stroke, botulinum toxin injection in the lower limb spastic muscles combined with an exercise program helps people to walk faster and longer and improves their quality of life.
Interventions
The intervention group will receive BT injection (up to 400 units of Botulinum toxin, Allergan reconstituted with 2ml of normal saline) into the lower limb spastic muscles, single injection. The specific dose is determined by assessing the spasticity by Modified Ashworth Scale (MAS) and the number of spastic muscle. The study physician (myself for this trial) will administer the intervention and also the placebo. The trial will be conducted in the specialised multidisciplinary spasticity clinic
The intervention group will receive BT injection (up to 400 units of Botulinum toxin, Allergan reconstituted with 2ml of normal saline) into the lower limb spastic muscles, single injection. The specific dose is determined by assessing the spasticity by Modified Ashworth Scale (MAS) and the number of spastic muscle. The study physician (myself for this trial) will administer the intervention and also the placebo. The trial will be conducted in the specialised multidisciplinary spasticity clinic consisting of the rehabilitation physician, nurse, physiotherapist, and the orthotist. Besides the intervention (active or placebo) all participants will receive a structured physiotherapy program. Strategies will be placed to monitor and ensure the reliability and validity of the interventions. The process fidelity i.e. the consistency in which intervention content will be delivered, will be monitored by the study physician and the nurse. The content fidelity i.e. delivery of the intervention components delivered as per prescription, will be ensured by the study physician and the physiotherapist. We will employ some strategies such as treatment manuals, written exercise program and telephone intervention to ensure intervention adherence. Structured physiotherapy will be delivered by a senior physiotherapist experienced in treating the stroke patients. The therapy will consist of stretching, balancing, strengthening exercises, and gait training. Each session will last for 45 minutes (duration) in the physiotherapy department of the Queen Elizabeth Hospital, two times per week (frequency) and will be of moderate intensity (Borg's scale 4-6). A similar home exercise program will also be developed. Participants will undergo baseline assessment and follow ups as described in the protocol at three weeks, three months and five months. Home exercise program will be monitored by the physician and the physiotherapist by making telephone calls
Sponsors
The Hospital Research Foundation
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Outcome results
None listed