Diplegic Cerebral Palsy and Action Observation Training

Diplegic Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05209282
• Other study ID #: 2021/2663
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: October 31, 2022

Study information

• Verified date: April 2023
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 31, 2022
• Est. primary completion date: February 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Diplegic Cerebral Palsy
• Paralysis

Intervention

Other:
• Video Based Action Observation
Individuals in this group will receive video-based action observation training in addition to the conventional physiotherapy program.
• Live Action Observation
Individuals in this group will receive live action observation training in addition to the conventional physiotherapy program.
• Conventional physiotherapy program
Individuals in this group will only receive a conventional physiotherapy program.

Locations

Country	Name	City	State
Turkey	Inonu University	Malatya	Battalgazi/MALATYA

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gross Motor Function Measure	Gross Motor Function measure is used to evaluate Motor Functions	8weeks
Primary	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	Pediatric berg balance scale	The test is performed progressively from timed sitting balance to standing on one leg.	8weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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