NCT03472261

Brief Summary

Pronation deformity is a very common problem in children with cerebral palsy. This deformity is usually has neural and non-neural aspects. In this clinical trial the aim is to show the importance of combine treatment approach with pharmacological and non-pharmacological modalities. .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 21, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

March 26, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

April 16, 2020

Status Verified

April 1, 2020

Enrollment Period

2 years

First QC Date

March 14, 2018

Last Update Submit

April 15, 2020

Conditions

Cerebral Palsy

Keywords

cerebral palsybotulinum toxin-Apronator deformity

Outcome Measures

Primary Outcomes (1)

  • Mean change from baseline Modified Ashworth Scale (MAS)

    Tone measurement

    Week 12

Secondary Outcomes (3)

  • Mean change from baseline passive range of supination

    Week 12

  • Mean change from baseline angle of catch (XV3) Tardieu scale

    Week 12

  • Mean change from baseline active range of supination

    Week 12

Other Outcomes (1)

  • Assisting Hand Assessment (AHA)

    Week 12

Study Arms (2)

Experimental Group

EXPERIMENTAL

Patients treated by Botulinum toxin A and twister and specific home exercise program

Drug: Botulinum toxin type AOther: Upper extremity orthosesOther: Home exercise program

Conventional Therapy Group

ACTIVE COMPARATOR

Patients treated by Botulinum toxin A and specific home exercise program

Drug: Botulinum toxin type AOther: Home exercise program

Interventions

Botulinum toxin type ADRUG

Dysport

Conventional Therapy GroupExperimental Group
Upper extremity orthosesOTHER

Twister

Experimental Group
Home exercise programOTHER

Specific exercises for pronation deformity

Conventional Therapy GroupExperimental Group

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of cerebral palsy
  • MAS score of pronator muscles at least 2
  • Gross Motor Functional Classification Scale level of I-IV
  • Scheduled to receive botulinum toxin injections to pronator teres and/or -pronator quadratus muscles besides other spastic upper extremity muscles

You may not qualify if:

  • Severe cognitive or behavioural problems
  • Less than 40 degrees of available passive range of motion in pronation
  • Severe dystonia in the affected upper limb
  • Received orthopedic surgery to affected 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 A

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 Factors

Study Officials

  • Melike Akarsu, MSc

    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

Study Record Dates

First Submitted

March 14, 2018

First Posted

March 21, 2018

Study Start

March 26, 2018

Primary Completion

March 30, 2020

Study Completion

March 30, 2020

Last Updated

April 16, 2020

Record last verified: 2020-04

Locations

TU(1)