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Efficacy of botulinum toxin in pediatric spasticity: a randomized trial comparing 2- to 4- sites hamstring injection

Efficacy of botulinum toxin in pediatric spasticity: a randomized trial comparing 2- to 4- sites hamstring injection

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20150803003
Enrollment
80
Registered
2015-08-03
Start date
2015-08-07
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Spastic Cerebral palsy Cerebral palsy Muscle Spasticity Botulinum Toxins

Interventions

Injected Botulinum toxin 2 points in Hamstring muscle,Injected Botulinum toxin 4 points in Hamstring muscle,as standard practical treatment in Thailand
2 points injection,4 points injection,standard treatment

Sponsors

Thammasat University
Lead Sponsor
Faculty of Medicine
Collaborator

Eligibility

Sex/Gender
All
Age
2 Years to 7 Years

Inclusion criteria

Inclusion criteria: Cerebral palsy children who have spasticity Modified Ashworth Scale-Bohannon (MAS-B) score 1+, 2 and 3 in Hamstring muscles

Exclusion criteria

Exclusion criteria: 1. surgery or accident in lower extremities muscles before. 2. injected with Botulinum toxin six months before joining the study. 3. allergic to the components of the Botulinum toxin. 4. have Neuromuscular disease such as Myasthenia gravis and Eaton Lambert syndrome or on the medication that affects the use of botulinum toxin. 5. have an easily bleeding tendency disease or on an anti-blood clotting medication.

Design outcomes

Primary

MeasureTime frame
Range of Motion 0, 1, 2, 3, 4, 5, 6 month Modified Tardieu Scale

Secondary

MeasureTime frame
Spasticity 0, 1, 2, 3, 4, 5, 6 month Modified Ashworth Scale-Bohannon (MAS-B) ,Gait 0, 1, 3, 6 month The Edinburgh Visual Gait Score (EVGS) ,Motor Function 0, 1, 3, 6 month Gross motor function measure - 66 (GMFM) ,Quality of Life 0, 1, 3, 6 month Pediatric Quality of Life Inventoryâ„¢ (PedsQLâ„¢) ,Satisfaction 0, 1, 3, 6 month Goal Attainment Scaling (GAS)

Countries

Thailand

Contacts

Public ContactChuenchom Chueluecha

Department of Rehabilitation Medicine, Faculty of Medicine, Thammasat University

puaichuenchom@hotmail.com66894584620

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026