None listed
Conditions
Brief 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.
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 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
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.
Sponsors
Dr Lisa Copeland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
2 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
1. Child receiving lower limb Botulinum Toxin-A (BTX-A)injections under general anaesthetic.2.Child >10kg 3.Lower limb BTX-A dose does not exceed 14units/kg – so as to allow for safe low dose upper limb injection (total lower limb dose not to exceed 370 units).4.Child has cerebral palsy5.Child has spasticity in adductor pollicis, opponens pollicis or flexor pollicis brevis that impacts on function, hygiene or splint tolerance.6.Parent and/or child have goals for improvement of the thumb that relate to function, care and comfort, hygiene or splint tolerance.7.Parents need to be willing to commit to a home program and occupational therapy review and outcome measure appointments.8.Written informed consent has been obtained from the parent or guardian.9.For children taking oral antispasticity medications (such as Baclofen) the dose relative to body weight must be stable for a period of 3 months prior to commencement of the study.
Exclusion criteria
1.Medical contraindications to BTX-Aa.Known hypersensitivity to botulinum toxin A or the components of its formulation,b.Myasthenia gravis or Eaton-Lambert Syndrome,c.Presence of infection at injection site,2.Amyotrophic lateral sclerosis or other disorders producing a depletion of acetylcholine at the neuromuscular junction,3.Concurrent use of any drugs that interfere with neuromuscular transmission, e.g. aminoglycoside antibiotics, spectinomycin or tubocurarine-type muscle relaxants.4.Inability to commit to assessment appointments and an active home therapy program. 5.Prior surgery to thumb for spasticity or contracture management.6.Previous BTX-A treatment to the upper limb within the last 6 months.7.Oral anti-spasticity medication (e.g. baclofen) unless the dose has been stable relative to weight for at least 3 months.8.Athetosis9.Where the child uses the spasticity in the thumb for function.10.Where the child has spasticity in their long finger flexors that restricts adequate finger extension to achieve functional grasp.
Outcome results
None listed