Integrated Management With Brain Stimulation and Hybrid Training Enhances Functional Gains in Children With Cerebral Palsy Treated by Botulinum Toxin A

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

Sponsors

Lead sponsor: Kocaeli University

Source 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.

Overall Status Completed
Start Date January 18, 2016
Completion Date January 30, 2020
Primary Completion Date January 30, 2020
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Assisting Hand Assesment 6 weeks
Secondary Outcome
Measure Time Frame
Jebsen Taylor Hand Function Test 6 weeks
Enrollment 40
Condition
Intervention

Intervention type: Drug

Intervention name: Botulinum toxin type A

Other name: Botox, Dysport

Intervention type: Device

Intervention name: transcranial direct current stimulation

Arm group label: İntensive Therapy Group

Other name: noninvasiv brain stimulation

Intervention type: Other

Intervention name: hybrid training model of CIMT and BIT

Arm group label: İntensive Therapy Group

Intervention type: Other

Intervention name: usual care

Arm group label: Control Group

Other name: physical therapy

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

Gender: All

Minimum age: 5 Years

Maximum age: 16 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Nigar Dursun, MD Principal Investigator Kocaeli University
Location
facility Kocaeli University
Location Countries

Turkey

Verification Date

April 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Kocaeli University

Investigator full name: Nigar Dursun

Investigator title: Professor, MD

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: İntensive Therapy Group

Arm group type: Experimental

Description: 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

Arm group label: Control Group

Arm group type: Active Comparator

Description: Children who received Botulinum toxin type A to plegic upper limb would continue their usual care

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Investigator)

Source: ClinicalTrials.gov