RecruitingPhase 3ACTRN12606000492550

"Thumbs up!"

Randomised double blind clinical control trial comparin injections of botulinum toxin A with saline placebo to the intrinsic muscles of the thumb in children with cerebral palsy to assess improved performance in individual goal areas as measured by goal attainment scaling.


Sponsor

Dr Lisa Copeland

Enrollment

40 participants

Start Date

Nov 6, 2006

Study Type

Interventional

Conditions

Summary

To examine whether botulinum toxin – A (BTX-A) injections into the intrinsic muscles of the thumb, when combined with a regimen of occupational therapy and home therapy improves the attainment of individual goals when compared to a home and occupational therapy program alone.


Eligibility

Sex: Both males and femalesMin Age: 2 YearssMax Age: 12 Yearss

Plain Language Summary

Simplified for easier understanding

This study looks at whether Botulinum Toxin-A (BTX-A) injections into the small muscles of the thumb — combined with occupational therapy and home exercises — can help children with cerebral palsy use their thumbs better. Cerebral palsy can make the thumb stiff and difficult to move, which affects everyday tasks like gripping objects, hygiene, and wearing splints. The trial compares two groups: one that receives BTX-A injections plus therapy, and one that receives therapy alone. You may be eligible if: - Your child is between 2 and 12 years old - Your child has cerebral palsy - Your child already receives lower limb BTX-A injections under general anaesthetic - Your child weighs more than 10 kg - Your child has stiffness in the thumb muscles that affects function, hygiene, or splint use - You (the parent or guardian) are willing to take part in a home therapy program and clinic appointments - You have provided written informed consent You may NOT be eligible if: - Your child has a known allergy to botulinum toxin A or its ingredients - Your child has myasthenia gravis or a similar nerve-muscle condition - Your child has an active infection at the injection site - Your child takes certain antibiotics or muscle relaxants that interfere with nerve function - Your child has had thumb surgery for spasticity or contracture - Your child received BTX-A to the upper limb within the last 6 months - Your child uses the thumb stiffness as part of how they grip or function Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Treatment group: Single episode of Botulinum toxin A (BTX-A) injections into the intrinsic muscles of the thumb (dosage of 0.5 U/kg BTX-A (max 20 units) injected into flexor pollicis brevis, opponens

Treatment group: Single episode of Botulinum toxin A (BTX-A) injections into the intrinsic muscles of the thumb (dosage of 0.5 U/kg BTX-A (max 20 units) injected into flexor pollicis brevis, opponens pollicis or adductor pollicis to a maximum total dose of 1.5 U/kg or 30 units) + casting for one week, home therapy program (to be carried out daily for 8 weeks) and resting hand splints to be worn daily (for resting time over night eg 10 hours) for 8 weeks. Botulinum toxin A dosing to be determined by blinded physician. Muscles injected dependent upon clinical determinants of spasticity in those muscles Home therapy programme will involve a range of activities selected according to the child's individual goals and will take approximately 20 minutes per day. For example: strengthening excercises for thumb flexors with playdoh.


Locations(1)

Australia

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