NCT05209282

Brief Summary

In this study, video-based action observation training and live action observation training in children with spastic diplegic cerebral palsy; It was aimed to examine the effect on motor function, activity participation and secondary outcome measures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

January 1, 2022

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

February 9, 2024

Status Verified

April 1, 2023

Enrollment Period

2 months

First QC Date

January 13, 2022

Last Update Submit

February 8, 2024

Conditions

Keywords

Action Observation TherapyDiplegic Cerebral PalsyMirror Neuron SystemMotor FunctionActivity ParticipationSecondary Outcome Measures

Outcome Measures

Primary Outcomes (2)

  • Gross Motor Function Measure

    Gross Motor Function measure is used to evaluate Motor Functions

    8weeks

  • The Child and Adolescent Scale of Participation (CASP)

    The CASP questionnaire is a questionnaire that evaluates the individual's community participation in the home, school, neighborhood settings.

    8weeks

Secondary Outcomes (5)

  • Pediatric berg balance scale

    8weeks

  • Timed Up and Go Test (TUG)

    8weeks

  • Gillette Functional Assessment Questionnaire

    8weeks

  • One-Minute Walk Test

    8weeks

  • Sit to Stand Test

    8weeks

Study Arms (3)

Grup I

EXPERIMENTAL

Conventional physiotherapy program, Video-based action observation training

Other: Video Based Action ObservationOther: Conventional physiotherapy program

Grup II

EXPERIMENTAL

Conventional physiotherapy program, Live Action Observation Training

Other: Live Action ObservationOther: Conventional physiotherapy program

Grup III

OTHER

Conventional physiotherapy program

Other: Conventional physiotherapy program

Interventions

Individuals in this group will receive video-based action observation training in addition to the conventional physiotherapy program.

Also known as: Conventional physiotherapy program
Grup I

Individuals in this group will receive live action observation training in addition to the conventional physiotherapy program.

Also known as: Conventional physiotherapy program
Grup II

Individuals in this group will only receive a conventional physiotherapy program.

Grup IGrup IIGrup III

Eligibility Criteria

Age5 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Being diagnosed with spastic diplegic cerebral palsy,
  • To be between the ages of 5-14,
  • To be at GMFCS I, II and III levels,
  • To have the cognitive level to follow the instructions given by the researchers,
  • IQ\> 70 (to be accessed from patient files),
  • Those who do not have serious restrictions in joint movement,

You may not qualify if:

  • Children with joint contractures,
  • Not having visual impairment and visual field defect,
  • Children who have had a seizure in the last 6 months or children who cannot be controlled despite seizure medication
  • Those who received botulinum injections 6 months before the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, Battalgazi/MALATYA, 44280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Burcu TALU, Assoc. Prof.

    Inonu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Experimental, Randomized Controlled Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.

Study Record Dates

First Submitted

January 13, 2022

First Posted

January 26, 2022

Study Start

January 1, 2022

Primary Completion

February 24, 2022

Study Completion

October 31, 2022

Last Updated

February 9, 2024

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations