Skip to main content
OpenTrials
Completed

NCT Number: NCT03302871

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kocaeli University

Kocaeli, 41050, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum Toxin Type A

Drug

Other names: Botox, Dysport

Transcranial Direct Current Stimulation

Device

Other names: noninvasiv brain stimulation

hybrid training model of CIMT and BIT

Other

Usual Care

Other

Other names: physical therapy

Primary outcomes

  1. Assisting Hand Assesment

    Time frame: 6 weeks

    Bilateral Hand Function Evaluation Instrument

Secondary outcomes

  1. Jebsen Taylor Hand Function Test

    Time frame: 6 weeks

    Unilateral Hand Function Evaluation Instrument

Other outcomes

  1. Modifed Ashworth Scale

    Time frame: 6 weeks

    Measurement of Tone

  2. Active ROM of wrist dorsiflexion

    Time frame: 6 weeks

    Measurement of active muscle function

  3. Modified Tardieu Scale

    Time frame: 6 weeks

    Measurement of spasticity

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Oct 5, 2017
Registry last updated
Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.