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

Phase 3

Completed

• Conditions: Cerebral Palsy
• Interventions: Drug: Botulinum toxin type A; Device: transcranial direct current stimulation; Other: usual care; Other: hybrid training model of CIMT and BIT

• Registration Number: NCT03302871
• Lead Sponsor: Kocaeli University

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.

Study Timeline

• Study Start: 2016-01-18
• Study First Submitted: 2017-10-02
• Study First Submitted QC: 2017-10-02
• Study First Posted: 2017-10-05
• Primary Completion: 2020-01-30
• Study Completion: 2020-01-30
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-22
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
İntensive Therapy Group	transcranial direct current stimulation	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
İntensive Therapy Group	hybrid training model of CIMT and BIT	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
Control Group	usual care	Children who received Botulinum toxin type A to plegic upper limb would continue their usual care
İntensive Therapy Group	Botulinum toxin type A	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
Control Group	Botulinum toxin type A	Children who received Botulinum toxin type A to plegic upper limb would continue their usual care

Primary Outcome Measures

Name	Time	Method
Assisting Hand Assesment	6 weeks	Bilateral Hand Function Evaluation Instrument

Secondary Outcome Measures

Name	Time	Method
Jebsen Taylor Hand Function Test	6 weeks	Unilateral Hand Function Evaluation Instrument

Trial Locations

Locations (1)

Kocaeli University; 🇹🇷 Kocaeli, Turkey