Cerebral Palsy
Conditions
Keywords
cerebral palsy, botulinum toxin-A, pronator deformity
Brief summary
Pronation deformity is a very common problem in children with cerebral palsy. This deformity is usually has neural and non-neural aspects. In this clinical trial the aim is to show the importance of combine treatment approach with pharmacological and non-pharmacological modalities. .
Detailed description
Spasticity is not only the most common motor disorder but also the main cause of slowly developing contractures in children with cerebral palsy. Pronation deformity which is a very common problem in children with cerebral palsy is primarily due to spasticity of the pronator muscles. Reduced strength and loss of control of the supinator muscles and soft tissue and joint contractures usually coexist with spasticity of pronator muscles. There is very limited information about how to treat this deformity in the current literature. In this prospective, randomized, controlled clinical trial the aim is to show the effectiveness of twister, and home exercise program in an integrated approach with BoNT-A injections on spasticity, and passive range of motion (pROM) of children with CP having pronation deformity.
Interventions
DRUGBotulinum toxin type A
Dysport
OTHERUpper extremity orthoses
Twister
OTHERHome exercise program
Specific exercises for pronation deformity
Sponsors
Kocaeli University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of cerebral palsy * MAS score of pronator muscles at least 2 * Gross Motor Functional Classification Scale level of I-IV * Scheduled to receive botulinum toxin injections to pronator teres and/or -pronator quadratus muscles besides other spastic upper extremity muscles
Exclusion criteria
* Severe cognitive or behavioural problems * Less than 40 degrees of available passive range of motion in pronation * Severe dystonia in the affected upper limb * Received orthopedic surgery to affected upper limb
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline Modified Ashworth Scale (MAS) | Week 12 | Tone measurement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline passive range of supination | Week 12 | Range of motion measurement |
| Mean change from baseline angle of catch (XV3) Tardieu scale | Week 12 | Spasticity measurement |
| Mean change from baseline active range of supination | Week 12 | Active range of motion |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assisting Hand Assessment (AHA) | Week 12 | Bilateral hand use |
Countries
Turkey (Türkiye)
Outcome results
None listed