Integrated Management With Brain Stimulation and Hybrid Training Enhances Functional Gains in Children With Cerebral Palsy Treated by Botulinum Toxin A
Overview
- Phase
- Phase 3
- Intervention
- Botulinum toxin type A
- Conditions
- Cerebral Palsy
- Sponsor
- Kocaeli University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Assisting Hand Assesment
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Detailed Description
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.
Investigators
Nigar Dursun
Professor, MD
Kocaeli University
Eligibility Criteria
Inclusion Criteria
- •diagnosis of unilateral cerebral palsy
- •able to activate wrist and finger extensors
- •being scheduled for BoNT-A treatment for upper limb
Exclusion Criteria
- •significant loss of wrist and or fingers
- •history of orthopedic surgery to plegic upper limb
Arms & Interventions
İntensive Therapy Group
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
Intervention: Botulinum toxin type A
İntensive Therapy Group
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
Intervention: transcranial direct current stimulation
İntensive Therapy Group
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
Intervention: hybrid training model of CIMT and BIT
Control Group
Children who received Botulinum toxin type A to plegic upper limb would continue their usual care
Intervention: Botulinum toxin type A
Control Group
Children who received Botulinum toxin type A to plegic upper limb would continue their usual care
Intervention: usual care
Outcomes
Primary Outcomes
Assisting Hand Assesment
Time Frame: 6 weeks
Bilateral Hand Function Evaluation Instrument
Secondary Outcomes
- Jebsen Taylor Hand Function Test(6 weeks)