NCT03302871

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2016

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

4 years

First QC Date

October 2, 2017

Last Update Submit

April 22, 2020

Conditions

Cerebral Palsy

Keywords

cerebral palsybotulinum toxin Aconstraint induced movement therapytranscranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

  • Assisting Hand Assesment

    Bilateral Hand Function Evaluation Instrument

    6 weeks

Secondary Outcomes (1)

  • Jebsen Taylor Hand Function Test

    6 weeks

Other Outcomes (3)

  • Modifed Ashworth Scale

    6 weeks

  • Active ROM of wrist dorsiflexion

    6 weeks

  • Modified Tardieu Scale

    6 weeks

Study Arms (2)

İntensive Therapy Group

EXPERIMENTAL

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

Drug: Botulinum toxin type ADevice: transcranial direct current stimulationOther: hybrid training model of CIMT and BIT

Control Group

ACTIVE COMPARATOR

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

Drug: Botulinum toxin type AOther: usual care

Interventions

Botulinum toxin type ADRUG
Also known as: Botox, Dysport
Control Groupİntensive Therapy Group
transcranial direct current stimulationDEVICE
Also known as: noninvasiv brain stimulation
İntensive Therapy Group
hybrid training model of CIMT and BITOTHER
İntensive Therapy Group
usual careOTHER
Also known as: physical therapy
Control Group

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • diagnosis of unilateral cerebral palsy
  • able to activate wrist and finger extensors
  • being scheduled for BoNT-A treatment for upper limb

You may not qualify if:

  • significant loss of wrist and or fingers
  • history of orthopedic surgery to plegic upper limb

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, 41050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Botulinum Toxins, Type AabobotulinumtoxinATranscranial Direct Current Stimulation2-(4-ethoxybenzyl)-1-diethylaminoethyl-5-isothiocyanatobenzimidazolePhysical Therapy Modalities

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological FactorsElectric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological TechniquesRehabilitation

Study Officials

  • Nigar Dursun, MD

    Kocaeli University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD

Study Record Dates

First Submitted

October 2, 2017

First Posted

October 5, 2017

Study Start

January 18, 2016

Primary Completion

January 30, 2020

Study Completion

January 30, 2020

Last Updated

April 24, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)