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

NCT ID: NCT03302871

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-18
• Study Completion Date: 2020-01-30

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Botulinum toxin type A

Intervention Type: DRUG

transcranial direct current stimulation

Intervention Type: DEVICE

hybrid training model of CIMT and BIT

Intervention Type: OTHER

Control Group

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

Group Type: ACTIVE_COMPARATOR

Botulinum toxin type A

Intervention Type: DRUG

usual care

Intervention Type: OTHER

Interventions

Botulinum toxin type A

Intervention Type: DRUG

transcranial direct current stimulation

Intervention Type: DEVICE

hybrid training model of CIMT and BIT

Intervention Type: OTHER

usual care

Intervention Type: OTHER

Other Intervention Names

Botox, Dysport; noninvasiv brain stimulation; 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kocaeli University

OTHER

Sponsor Role: lead

Responsible Party

Nigar Dursun

Professor, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nigar Dursun, MD

Role: PRINCIPAL_INVESTIGATOR

Kocaeli University

Locations

Kocaeli University

Kocaeli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KOUKAEK 2016/20

Identifier Type: -

Identifier Source: org_study_id