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

NCT03302871 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-04-24

No results posted yet for this study

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.

Conditions

  • Cerebral Palsy

Interventions

DRUG

Botulinum toxin type A

DEVICE

transcranial direct current stimulation

OTHER

hybrid training model of CIMT and BIT

OTHER

usual care

Sponsors & Collaborators

  • Kocaeli University

    lead OTHER

Principal Investigators

  • Nigar Dursun, MD · Kocaeli University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-18
Primary Completion
2020-01-30
Completion
2020-01-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03302871 on ClinicalTrials.gov