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Diplegic Cerebral Palsy and Action Observation Training

Primary Purpose

Diplegic Cerebral Palsy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Video Based Action Observation
Live Action Observation
Conventional physiotherapy program
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diplegic Cerebral Palsy focused on measuring Action Observation Therapy, Diplegic Cerebral Palsy, Mirror Neuron System, Motor Function, Activity Participation, Secondary Outcome Measures

Eligibility Criteria

5 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Inonu University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Grup I

Grup II

Grup III

Arm Description

Conventional physiotherapy program, Video-based action observation training

Conventional physiotherapy program, Live Action Observation Training

Conventional physiotherapy program

Outcomes

Primary Outcome Measures

Gross Motor Function Measure
Gross Motor Function measure is used to evaluate Motor Functions
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.

Secondary Outcome Measures

Pediatric berg balance scale
The test is performed progressively from timed sitting balance to standing on one leg.
Timed Up and Go Test (TUG)
It is a test that measures the mobility of the child and evaluates both dynamic and static balance.
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.
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.
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.

Full Information

First Posted
January 13, 2022
Last Updated
September 8, 2022
Sponsor
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT05209282
Brief Title
Diplegic Cerebral Palsy and Action Observation Training
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diplegic Cerebral Palsy
Keywords
Action Observation Therapy, Diplegic Cerebral Palsy, Mirror Neuron System, Motor Function, Activity Participation, Secondary Outcome Measures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental, Randomized Controlled Study
Masking
Participant
Allocation
Randomized
Enrollment
39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Grup I
Arm Type
Experimental
Arm Description
Conventional physiotherapy program, Video-based action observation training
Arm Title
Grup II
Arm Type
Experimental
Arm Description
Conventional physiotherapy program, Live Action Observation Training
Arm Title
Grup III
Arm Type
Other
Arm Description
Conventional physiotherapy program
Intervention Type
Other
Intervention Name(s)
Video Based Action Observation
Other Intervention Name(s)
Conventional physiotherapy program
Intervention Description
Individuals in this group will receive video-based action observation training in addition to the conventional physiotherapy program.
Intervention Type
Other
Intervention Name(s)
Live Action Observation
Other Intervention Name(s)
Conventional physiotherapy program
Intervention Description
Individuals in this group will receive live action observation training in addition to the conventional physiotherapy program.
Intervention Type
Other
Intervention Name(s)
Conventional physiotherapy program
Intervention Description
Individuals in this group will only receive a conventional physiotherapy program.
Primary Outcome Measure Information:
Title
Gross Motor Function Measure
Description
Gross Motor Function measure is used to evaluate Motor Functions
Time Frame
8weeks
Title
The Child and Adolescent Scale of Participation (CASP)
Description
The CASP questionnaire is a questionnaire that evaluates the individual's community participation in the home, school, neighborhood settings.
Time Frame
8weeks
Secondary Outcome Measure Information:
Title
Pediatric berg balance scale
Description
The test is performed progressively from timed sitting balance to standing on one leg.
Time Frame
8weeks
Title
Timed Up and Go Test (TUG)
Description
It is a test that measures the mobility of the child and evaluates both dynamic and static balance.
Time Frame
8weeks
Title
Gillette Functional Assessment Questionnaire
Description
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.
Time Frame
8weeks
Title
One-Minute Walk Test
Description
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.
Time Frame
8weeks
Title
Sit to Stand Test
Description
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.
Time Frame
8weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dilan DEMİRTAŞ KARAOBA, PhD
Phone
+905541127796
Email
dilandemirtas92@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Burcu TALU, Assoc. Prof.
Phone
+905317910984
Email
fzt.burcu@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burcu TALU, Assoc. Prof.
Organizational Affiliation
Inonu University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inonu University
City
Malatya
State/Province
Battalgazi/MALATYA
ZIP/Postal Code
44280
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Diplegic Cerebral Palsy and Action Observation Training

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