Diplegic Cerebral Palsy and Action Observation Training

The Effect Of Video Based Action Observation Training And Live Action Observation Training On Motor Function, Activity Participation And Secondary Outcome Measures İn Children With Spastic Diplegic Cerebral Palsy

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.

Study Overview

• Status: Completed
• Conditions: Diplegic Cerebral Palsy
• Intervention / Treatment: Other: Video Based Action Observation; Other: Conventional physiotherapy program; Other: Live Action Observation

Detailed Description

The study was designed as a single-blind randomized controlled trial. Patients aged 5-14 years with spastic diplegic cerebral palsy will be included. Children will be assigned to groups through stratified randomisation; The patients will be divided into 3 groups as experimental and control groups. Group 1 (experiment): video-based action observation training in addition to the conventional rehabilitation program, Group 2 (experiment): live action observation training in addition to the conventional rehabilitation program, Group 3 (control) will receive only the conventional rehabilitation program. The experimental group will receive 20 minutes of action observation training after a conventional physiotherapy program for 20 minutes for 8 weeks, 40 minutes 2 days a week. The control group will receive 40 minutes of conventional treatment. Evaluations will be made for each group, before and 8 weeks after the start of the study. GMFM for gross motor function; Pediatric berg balance scale for balance function; Timed Up and Go Test for functional mobility assessment; Gillette Functional Assessment Questionnaire and 1-min walk test to assess functional walking; sit and stand test for functional muscle strength and to evaluate activity participation; The Child and Adolescent Participation Questionnaire (CASP) will be used.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Battalgazi/MALATYA
    • Malatya, Battalgazi/MALATYA, Turkey, 44280
      • Inonu University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 14 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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,

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Grup I; Conventional physiotherapy program, Video-based action observation training	Other: Video Based Action Observation; Individuals in this group will receive video-based action observation training in addition to the conventional physiotherapy program.; Other Names: Conventional physiotherapy program; Other: Conventional physiotherapy program; Individuals in this group will only receive a conventional physiotherapy program.
Experimental: Grup II; Conventional physiotherapy program, Live Action Observation Training	Other: Conventional physiotherapy program; Individuals in this group will only receive a conventional physiotherapy program.; Other: Live Action Observation; Individuals in this group will receive live action observation training in addition to the conventional physiotherapy program.; Other Names: Conventional physiotherapy program
Other: Grup III; Conventional physiotherapy program	Other: Conventional physiotherapy program; Individuals in this group will only receive a conventional physiotherapy program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric berg balance scale	The test is performed progressively from timed sitting balance to standing on one leg.	8weeks
Timed Up and Go Test (TUG)	It is a test that measures the mobility of the child and evaluates both dynamic and static balance.	8weeks
Gillette Functional Assessment Questionnaire	Gillette FDA is a self-reported or self-reported assessment. Gillette FDA; It includes the FDA Gait Scale, which classifies ambulation function at 10 levels, and the 22-item Skills Test assessing functional locomotor activity.	8weeks
One-Minute Walk Test	It is an inexpensive and user-friendly test that can be used to assess functional ability with the 1-minute fast walking test. During the test, children wear their comfortable clothes and shoes. Children who wear orthoses are evaluated with orthoses, and children who walk with a mobility aid are evaluated with mobility aids.	8weeks
Sit to Stand Test	The child is asked to get up from a chair without armrests and sit back down again, with his hips and knees flexed to 90 degrees and his feet in full contact with the ground. The time to sit and stand up to 5 times is determined by the stopwatch.	8weeks

Collaborators and Investigators

• Sponsor: Inonu University
• Investigators: Principal Investigator: Burcu TALU, Assoc. Prof., Inonu University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): February 24, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: January 13, 2022
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Motor Function; Action Observation Therapy; Diplegic Cerebral Palsy; Mirror Neuron System; Activity Participation; Secondary Outcome Measures
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: 2021/2663

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No