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
Phase 4
- Conditions
- Thumb in palm deformity frequently seen in children with spastic cerebral palsyThe consequences can be burdensome and lifelongImpairs the ability to use the thumb Limits hand function and range of motion Management of thumb in palm deformity is multi-disciplinaryThumb in palm deformity, hand function, spastic cerebral palsy, Botulinum toxin type A, hand splint, spasticity, range of motion
- Registration Number
- TCTR20230417007
- Lead Sponsor
- Ratchadapisek Research Funds(For graduate students, residents, fellows)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 36
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hand function at 4 week and 12 week after start the intervention Quality of upper extremity skills test-Grasp domain
- Secondary Outcome Measures
Name Time Method 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