Health Condition 1: I699- Sequelae of unspecified cerebrovascular diseases
Conditions
Interventions
Intervention1: Botulinum toxin A: Clostridium botulinum Toxin Type A 100 IU, single divided dose (65 IU in medial gastrocnemius and 35 IU in lateral gastrocnemius),administered as a one time intramusc
Sponsors
Dr Anupam Gupta
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males/females of age 18 to 70, currently suffering from post-stroke spastic equinus deformity 2. Sub-acute (3 weeks or more) or chronic stroke 3. Patients with dynamic spastic equinus on the affected side. 4. Participants who can and are willing to provide written informed consent. 5. Ambulatory at the time of recruitment
Exclusion criteria
Exclusion criteria: 1. Participant with a known history of allergy to Botulinum toxin A or history or presence of multiple severe allergies. 2. Female participant who is pregnant or breastfeeding. 3. Participant with history of previous injection of botulinum Toxin within six months. 4. Patients with static (fixed) equinus deformity of the foot. 5. Participant having a mental or physical condition that would render the subject unable to meet the requirements of the protocol. 6. Participant with a history of participation in another clinical study involving another investigational agent within 4 weeks prior to the start of this trial, or planning participation in another clinical trial during the current study duration. 7. Participant with concurrent illnesses like Parkinsons, myasthenia gravis, Eaton Lambert syndrome, amyotrophic lateral sclerosis or any other disease that might interfere with neuromuscular function. 8. History or concurrent use of other drugs that interfere with neuromuscular function within 3 months prior to enrollment into the study. 9. Participant with infection at injection sites as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. 10 meter walk test 2. Degree of equinus deformity at ankleTimepoint: At baseline and 3 weeks after injection | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 6 minute walk test 2. Functional Ambulation category 3. Modified Ashworth ScaleTimepoint: At baseline and 3 weeks after injection | — |
Countries
India
Contacts
Public ContactDr Anupam Gupta
National Institute of Mental Health and Neurosciences (NIMHANS), Bengaluru
Outcome results
None listed