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The efficacy of low dose botulinum toxin A VS hand splint for thumb in palm deformity in spastic cerebral palsy children : A randomized controlled trial

The efficacy of low dose botulinum toxin A VS hand splint for thumb in palm deformity in spastic cerebral palsy children : A randomized controlled trial

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230417007
Enrollment
36
Registered
2023-04-17
Start date
2023-06-01
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

Thumb in palm deformity frequently seen in children with spastic cerebral palsy The consequences can be burdensome and lifelong Impairs the ability to use the thumb Limits hand function and range of motion Management of thumb in palm deformity is multi-disciplinary Thumb in palm deformity, hand function, spastic cerebral palsy, Botulinum toxin type A, hand splint, spasticity, range of motion

Interventions

1. Medication is Botulinum toxin type A(Botox) 2.Preparations dilute 100 U of BTX-A with 2 mL(50 U/ml) of preservative-free 0.9% sodium chloride for injection. 3.Local anesthesia with EMLA ( lidocain
Experimental Drug,Experimental Device,Active Comparator Procedure/Surgery
Botulinum toxin type A,Hand splint,standard occupational Therapy

Sponsors

Ratchadapisek Research Funds(For graduate students, residents, fellows)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 8 Years

Inclusion criteria

Inclusion criteria: 1.Spastic CP with Thumb in palm deformity and impaired with hand functional use and/or limiting activities of daily living, 2.Inform consent and assent signed, 3.Between 3 and 8 years of age, 4. Modified ashworth scale (MAS) of adductor pollicis = 1-3, 5.Can follow at lease 1 step command

Exclusion criteria

Exclusion criteria: 1.Unstable medical or neurological condition, 2.Previous hand/arm surgery, 3.BoNT-A injections within the last 6 month, 4.Fixed contractures of upper limb, 5.Joint instability, 6.Can not wear a splint, 7.Contraindication of BoNT-A, lidocaine and Prilociane

Design outcomes

Primary

MeasureTime frame
Hand function at 4 week and 12 week after start the intervention Quality of upper extremity skills test-Grasp domain

Secondary

MeasureTime frame
Spasticity at 4 week and 12 week after start the intervention Modified Ashworth Scale,Range of motion at 4 week and 12 week after start the intervention Range of motion scale,Satisfaction at 4 week and 12 week after start the intervention Satisfaction scale

Countries

Thailand

Contacts

Public ContactSuthima Srifa

Faculty of Medicine, Chulalongkorn University

mdsrifa@gmail.com66836325845

Outcome results

None listed

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