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Clinical trial to compare the effect of Botulinum toxin vs Surgical management of lower limb deformities in children with spastic Cerebral Palsy

BOTULINUM TOXIN VERSUS SINGLE EVENT MULTILEVEL SURGERY (SEMLS) IN CHILDREN WITH LOWER LIMB DEFORMITIES IN SPASTIC CEREBRAL PALSY - A RANDOMISED COMPARATIVE TRIAL - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/03/005642
Enrollment
50
Registered
2015-03-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Spastic cerebral palsy with dynamic contractures in lower limbs

Interventions

Intervention1: Botulinum Toxin: Intramuscular injections of botulinum toxin was administered among children included in this toxin group. Dose based on the weight and spastic muscle group of the patie

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Known cases of Cerebral Palsy with dynamic contractures of lower limb muscles 2. Children with spastic cerebral palsy with abnormal gait 3. Children falling into GMFC scores of I, II and III

Exclusion criteria

Exclusion criteria: 1. Children who have received Botulinum toxin previously 2. Patients who have undergone any surgical procedure previously for lower limb deformities 3. Known cases of Spastic Cerebral Palsy with severe mental retardation 4. Children who fall into grade IV, or V of GMFCS 5. Children with dyskinetic CP. 6. Children who are allergic to Botulinum toxin. 7. Children who have received oral or intrathecal baclofen previously.

Design outcomes

Primary

MeasureTime frame
Improvement in Gait Correction of deformityTimepoint: 2 weeks, 3 months, 6 months

Secondary

MeasureTime frame
Risk Benefit ratio between Surgery versus Botulinum toxin injectionTimepoint: 2 weeks , 3 months, 6 months

Countries

India

Contacts

Public ContactMohammed Sadiq

AIIMS

sadiq22288@yahoo.com9968835869

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026