Effects of Action Observation Therapy and Video-Based Play Therapy on Children With Unilateral Cerebral Palsy
1 other identifier
interventional
30
1 country
1
Brief Summary
Cerebral Palsy (CP) defines a group of permanent disorders in the development of movement and posture, which occur in the developing fetal and newborn brain, due to non-progressive disorders, leading to activity limitations. In addition to the traditional rehabilitation interventions used in upper extremity rehabilitation, a new treatment method, Action Observation Therapy (AOT), has been added recently with the discovery of the Mirror Neuron System. AOT; By watching the videos prepared, mirror neurons are activated and these activities are learned through imitation. Activation of mirror neurons strengthens voluntary motor movement by strengthening the affected nerve pathways or by creating alternative pathways. AOT is an easily applicable method as telerehabilitation because it is based on watching and replaying video recordings. Virtual Rehabilitation (VR); It is another treatment approach applied to improve the motor functions of children with CP and created with the contribution of developing technology. It has been reported that activities have a positive effect on motor learning due to their intense, task-oriented, active participation and high motivation. Within the scope of this thesis, the effect of AOT and VR to be applied at home, which has been on the agenda for upper extremity, on the trunk and upper extremity will be examined in detail and a contribution will be made to the literature.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2022
Shorter than P25 for not_applicable
1 active site
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
April 7, 2022
CompletedFirst Posted
Study publicly available on registry
April 14, 2022
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedApril 14, 2022
April 1, 2022
4 months
April 7, 2022
April 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (22)
Sociodemographic Data Form
Information such as gender, age, clinical type, extremity involvement, dominant extremity, birth weight, assistive devices used of the cases will be recorded in the prepared sociodemographic data form
Before starting treatment
Joint Range of Motion (ROM) Measurement
Individuals' ROM degrees will be evaluated before and after the treatment using a universal goniometer in the supine position. Individuals' shoulder flexion, abduction, internal and external rotation, elbow and wrist flexion and extension painless active ROM measurements will be evaluated and recorded bilaterally.
Before starting treatment
Pediatric Quality of Life Inventory
The Pediatric Quality of Life Inventory (PedsQL™) is a modular instrument for measuring health-related quality of life dimensions in children and adolescents ages 2-18 years. The PedsQL™ 4.0 Generic Core Scales are multidimensional (physical, emotional, social, school/role functioning) child self-report and parent proxy report scales developed as a generic measure to be integrated with the PedsQL™ disease-specific modules.
Before starting treatment
The Jebsen Hand Function Test
The Jebsen Hand Function Test (JHFT) was developed to provide a standardized and objective evaluation of fine and gross motor hand function using simulated activities of daily living. It has 7 items and takes approximately 15-45 minutes to administer. Item 1: Writing, Item 2: Card Turning, Item 3: Small Common Objects, Item 4: Simulated feeding, Item 5: Checkers, Item 6: Large Light Object, Item 7: Large Heavy Objects
Before starting treatment
ABILHAND-Kids
ABILHAND-Kids is a measure of manual ability for children with upper limb impairments. The scale measures a person's ability to manage daily activities that require the use of the upper limbs, whatever the strategies involved. The ABILHAND-Kids questionnaire assesses manual ability as a test focused on the child's difficulty perceived by the child's parents. The questionnaire was developed using the Rasch measurement model which provides a method to convert the raw scores into a linear measure located on a unidimensional scale. ABILHAND-Kids has been calibrated in children with cerebral palsy according to the difficulty of children in performing manual activities as perceived by their parents.
Before starting treatment
The Quality of Upper Extremity Skills Test
The Quality of Upper Extremity Skills Test is an outcome measure designed to evaluate movement patterns and hand function in children with cerebral palsy. The QUEST is both reliable and valid. There are 36 items that evaluate dissociated movements, grip, protective extension, and weight bearing
Before starting treatment
Selective Control of the Upper Extremity Scale
This test was developed to evaluate the selective motor control of the upper extremity. It is a very practical and useful video-based assessment tool that can be applied in less than 15 minutes. No special equipment is required other than a video camera. It offers the opportunity to evaluate the selective movements of the shoulder, elbow, forearm, wrist and fingers for both right and left extremities. The person administering the test passively shows the participant the movements they are asked to do. Then the participant is asked to actively perform the movement shown. While performing the participant movements; Head, trunk and other extremity movements are taken with a video camera to provide the opportunity to observe. The degree of selective motor control is determined as 0-3 points for each joint, depending on the person's ability to perform movements and their shape.
Before starting treatment
Trunk Control Measurement Scale
The Trunk Control Measurement Scale (TCMS) was used to evaluate the trunk control of the individuals participating in the study. The TCMS includes 15 items that measure static and dynamic sitting balance, the two main components of trunk control. The Static Sitting Balance Scale (item 1-5) evaluates the ability to maintain a stable trunk posture during movements of the upper and lower extremities. The Dynamic Sitting Balance Scale (item 6-15) is divided into two subscales, the selective movement control scale and the dynamic reaching scale. The total score is between 0-58. A higher score indicates better performance.
Before starting treatment
Gross grip strength
The Association of American Handheld Runners (AAHR) set a standard position to measure hand grip strength. According to the standard position; The patient will be in a sitting position, shoulders in adduction, elbows in 90 degrees flexion, and forearm and wrist in neutral position. The unit of grip force will be accepted as Newton.
Before starting treatment
Pinch force
Pinch force was evaluated using a pinchmeter. In cases; Type, lateral and triple grip measurements will be made. The measurement position is recommended by the American Association of Hand Therapists; the shoulder will be in adduction and rotation-neutral position, the elbow will be in 90-degree flexion, and the forearm and wrist will be in neutral position. These conditions will be provided while the patient is in a sitting position.
Before starting treatment
Childhood Health Assessment Questionaire
CHAQ; It consists of 8 subsections and 30 questions: dressing and personal care, standing up, eating, walking, body care, reaching, holding, activities. In addition, the use of assistive devices, devices, pain and well-being are questioned. A separate and total score is calculated for each subsection. Each question is evaluated as no difficulty: 3, with some difficulty: 2, with great difficulty: 1, unable to do: 0 points. In our study, the cases in both groups will be evaluated with CHAQ.
Before starting treatment
Sociodemographic Data Form
Information such as gender, age, clinical type, extremity involvement, dominant extremity, birth weight, assistive devices used of the cases will be recorded in the prepared sociodemographic data form
After 3 weeks of treatment (treatment is 15 sessions)
Joint Range of Motion (ROM) Measurement
Individuals' ROM degrees will be evaluated before and after the treatment using a universal goniometer in the supine position. Individuals' shoulder flexion, abduction, internal and external rotation, elbow and wrist flexion and extension painless active ROM measurements will be evaluated and recorded bilaterally.
After 3 weeks of treatment (treatment is 15 sessions)
Pediatric Quality of Life Inventory
The Pediatric Quality of Life Inventory (PedsQL™) is a modular instrument for measuring health-related quality of life dimensions in children and adolescents ages 2-18 years. The PedsQL™ 4.0 Generic Core Scales are multidimensional (physical, emotional, social, school/role functioning) child self-report and parent proxy report scales developed as a generic measure to be integrated with the PedsQL™ disease-specific modules.
After 3 weeks of treatment (treatment is 15 sessions)
The Jebsen Hand Function Test
The Jebsen Hand Function Test (JHFT) was developed to provide a standardized and objective evaluation of fine and gross motor hand function using simulated activities of daily living. It has 7 items and takes approximately 15-45 minutes to administer. Item 1: Writing, Item 2: Card Turning, Item 3: Small Common Objects, Item 4: Simulated feeding, Item 5: Checkers, Item 6: Large Light Object, Item 7: Large Heavy Objects
After 3 weeks of treatment (treatment is 15 sessions)
ABILHAND-Kids
ABILHAND-Kids is a measure of manual ability for children with upper limb impairments. The scale measures a person's ability to manage daily activities that require the use of the upper limbs, whatever the strategies involved. The ABILHAND-Kids questionnaire assesses manual ability as a test focused on the child's difficulty perceived by the child's parents. The questionnaire was developed using the Rasch measurement model which provides a method to convert the raw scores into a linear measure located on a unidimensional scale. ABILHAND-Kids has been calibrated in children with cerebral palsy according to the difficulty of children in performing manual activities as perceived by their parents.
After 3 weeks of treatment (treatment is 15 sessions)
The Quality of Upper Extremity Skills Test
The Quality of Upper Extremity Skills Test is an outcome measure designed to evaluate movement patterns and hand function in children with cerebral palsy. The QUEST is both reliable and valid. There are 36 items that evaluate dissociated movements, grip, protective extension, and weight bearing
After 3 weeks of treatment (treatment is 15 sessions)
Selective Control of the Upper Extremity Scale
This test was developed to evaluate the selective motor control of the upper extremity. It is a very practical and useful video-based assessment tool that can be applied in less than 15 minutes. No special equipment is required other than a video camera. It offers the opportunity to evaluate the selective movements of the shoulder, elbow, forearm, wrist and fingers for both right and left extremities. The person administering the test passively shows the participant the movements they are asked to do. Then the participant is asked to actively perform the movement shown. While performing the participant movements; Head, trunk and other extremity movements are taken with a video camera to provide the opportunity to observe. The degree of selective motor control is determined as 0-3 points for each joint, depending on the person's ability to perform movements and their shape.
After 3 weeks of treatment (treatment is 15 sessions)
Trunk Control Measurement Scale
The Trunk Control Measurement Scale (TCMS) was used to evaluate the trunk control of the individuals participating in the study. The TCMS includes 15 items that measure static and dynamic sitting balance, the two main components of trunk control. The Static Sitting Balance Scale (item 1-5) evaluates the ability to maintain a stable trunk posture during movements of the upper and lower extremities. The Dynamic Sitting Balance Scale (item 6-15) is divided into two subscales, the selective movement control scale and the dynamic reaching scale. The total score is between 0-58. A higher score indicates better performance.
After 3 weeks of treatment (treatment is 15 sessions)
Gross grip strength
The Association of American Handheld Runners (AAHR) set a standard position to measure hand grip strength. According to the standard position; The patient will be in a sitting position, shoulders in adduction, elbows in 90 degrees flexion, and forearm and wrist in neutral position. The unit of grip force will be accepted as Newton.
After 3 weeks of treatment (treatment is 15 sessions)
Pinch force
Pinch force was evaluated using a pinchmeter. In cases; Type, lateral and triple grip measurements will be made. The measurement position is recommended by the American Association of Hand Therapists; the shoulder will be in adduction and rotation-neutral position, the elbow will be in 90-degree flexion, and the forearm and wrist will be in neutral position. These conditions will be provided while the patient is in a sitting position.
After 3 weeks of treatment (treatment is 15 sessions)
Childhood Health Assessment Questionaire
CHAQ; It consists of 8 subsections and 30 questions: dressing and personal care, standing up, eating, walking, body care, reaching, holding, activities. In addition, the use of assistive devices, devices, pain and well-being are questioned. A separate and total score is calculated for each subsection. Each question is evaluated as no difficulty: 3, with some difficulty: 2, with great difficulty: 1, unable to do: 0 points. In our study, the cases in both groups will be evaluated with CHAQ.
After 3 weeks of treatment (treatment is 15 sessions)
Study Arms (2)
Group 1
EXPERIMENTALAction Observation Treatment
Group 2
EXPERIMENTALVirtual Rehabilitation
Interventions
Action Observation Treatment program will be applied to the group 1 for 3 weeks, 5 days a week, 30 minutes a day. In the videos prepared, activities including daily life activities for the wrist, elbow and shoulder (emptying water from the glass, throwing sugar into the glass, painting, using clothespins, spoons, etc.) will be included.
Virtual Rehabilitation program will be applied to the group 2 for 3 weeks, 5 days a week, 30 minutes a day. Among the games, games that will improve daily life activities for the wrist, elbow and shoulder (steering wheel, popping balloons, touching the aquarium, etc.) will be selected.
Eligibility Criteria
You may qualify if:
- The clinical type is spastic hemiparetic CP.
- Upper extremity spasticity value between 0 and 3 according to Modified Ashworth.
- To have the cognitive level to understand simple instructions.
- It is largely the absence of auditory and visual loss.
You may not qualify if:
- Not volunteering to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sinem Erturanlead
Study Sites (1)
Gazi University
Ankara, None Selected, 06500, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
sinem erturan, MSc
bulentelbasan@gmail.com
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- research assistant
Study Record Dates
First Submitted
April 7, 2022
First Posted
April 14, 2022
Study Start
June 1, 2022
Primary Completion
October 1, 2022
Study Completion
December 1, 2022
Last Updated
April 14, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share