drugset / Trial / NCT03302871

Integrated Management Enhances Functional Gains in Children With Cerebral Palsy Treated by BoNT-A

NCT03302871

Phase 3 Completed 40 enrolled Kocaeli University
RandomizedParallel-groupSingle-blindTreatment

Summary

Evidence from literature support the use of Botulinum toxin A (BoNT-A) for upper limb spasticity management in children with cerebral palsy (CP). Constraint Induced Movement Therapy (CIMT) and Bilateral Intensive Training (BIT) are indicated as effective and complimentary treatments to improve motor function in these children. In a recent trial combined noninvasiv brain stimulation and CIMT enhanced therapy induced functional gains. In this clinical trial the aim was to evaluate the effects of transcranial direct current stimulation (t-DCS) plus intensive hybrid training model of modified CIMT and BIT when integrated with BoNT-A treatment in children with unilateral CP.

Timeline

Start
2016-01-18
Primary completion
2020-01-30
Completion
2020-01-30

Drugs

EvaluationDrugModalityDoseRoute
Background Botulinum toxin type A Protein / enzyme biologic

Indications