A Phase 3 interventional study of Botulinum toxin type A and transcranial direct current stimulation in Cerebral Palsy, sponsored by Kocaeli University. Completed at 1 site in Turkey. Open to participants aged 5 Years to 16 Years. Per ClinicalTrials.gov, last updated 2020-04-24.
Sponsored by Kocaeli University · Phase 3, Interventional, and Treatment
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.
Although BoNT-A is effective in spasticity management there is inconclusive evidence to support its usage for improvement in upper limb activity and function. Combination of BoNT-A and occupational therapy (OT) is found to be more effective then OT alone in reducing impairment, improving activity level and goal achievement. Intensive hybrid training models of CIMT and BIT and noninvasive brain stimulation are promising treatments on motor learning in children with CP. The aim of this clinical trial is to show the additional gains that could be provided by an integrated treatment of transcranial direct current stimulation (t-DCS) plus intensive hybrid training model of modified CIMT and BIT to BoNT-A injections in children with unilateral CP.
Exclusion Criteria:
Children who received Botulinum toxin type A to plegic upper limb would be treated by transcranial direct current stimulation and a hybrid training model of CIMT and BIT
Drug: Botulinum toxin type A · Device: transcranial direct current stimulation · Other: hybrid training model of CIMT and BIT
Children who received Botulinum toxin type A to plegic upper limb would continue their usual care
Drug: Botulinum toxin type A · Other: usual care
Also known as: Botox, Dysport
Also known as: noninvasiv brain stimulation
Also known as: physical therapy
Assisting Hand Assesment
Bilateral Hand Function Evaluation Instrument
Time frame: 6 weeks
Jebsen Taylor Hand Function Test
Unilateral Hand Function Evaluation Instrument
Time frame: 6 weeks
Modifed Ashworth Scale
Measurement of Tone
Time frame: 6 weeks
Active ROM of wrist dorsiflexion
Measurement of active muscle function
Time frame: 6 weeks
Modified Tardieu Scale
Measurement of spasticity
Time frame: 6 weeks
Plan to share: No
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Kocaeli University