Cerebral PalsyNCT05327179
Effects of Action Observation Therapy and Video-Based Play Therapy on Children With Unilateral Cerebral Palsy
A study testing Action Observation Treatment and Virtual Rehabilitation in people with Cerebral Palsy and Upper Extremity Problem, run by Sinem Erturan at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Cerebral Palsy, Upper Extremity Problem
- What is being tested?
- Action Observation Treatment and Virtual Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Not volunteering to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Action Observation Therapy and Video-Based Play Therapy on the Upper Extremity and Trunk in Children With Unilateral Cerebral Palsy in the Framework of the International Classification of Functioning, Disability, and Health
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.
Read the detailed description
Cerebral Palsy (CP) defines a group of permanent disorders in the development of movement and posture that occur in the developing fetal and newborn brain, due to non-progressive disorders, leading to activity limitations. Unilateral CP (uCP) accounts for 38% of cases. These children complain of motor and sensory disorders that are more prominent on one side of the body, usually in the upper extremity (UE). These sensorimotor disorders typically limit their ability to perform activities of daily living, negatively affecting participation and quality of life. Therefore, in the last ten years, research on UE interventions for children with uCP has been focused on; While trying to develop existing methods, new treatment methods are tried to be created. There are various treatment modalities that aim to relieve UE function disorders and reduce activity limitations. It is very important to determine the most effective treatment method. However, there are few randomized controlled studies measuring clinical outcomes in children with uCP. New intervention strategies based on sound methodological and scientific foundations are needed.
It has been reported that motor learning is the basis of UE treatments applied in CP and reported to be effective. Based on neurophysiological findings, there are studies suggesting that AOT and VR treatment approaches accelerate the motor learning process. AOT; It includes observing selected UE actions and actively imitating the observed action. AOT has been previously used in the treatment of upper extremity in patients with chronic stroke, recovery of frostbite phenomenon in Parkinson's disease, treatment of lower and upper extremities in pediatric rehabilitation, and recovery of limb function after orthopedic surgery and has been reported in studies. Recent studies, especially in children with uCP, have reported promising results. In general, telerehabilitation is an effective, flexible, personalized and relatively cost-effective intervention, which strengthens the hypothesis that home rehabilitation services are a viable alternative to routine care. AOT can be easily performed at home as it is an approach based on careful observation and active imitation of actions. approach has been reported. Studies have reported that VR improves posture, balance, upper extremity function, and trunk control. There is no study in the literature examining the effects of motor learning-based AOT and VR applied at home on UE and body within the framework of international functionality, disability and health classification. Within the scope of the study, a contribution will be made to the literature, which has been reported to be insufficient in studies on UE treatments.
- Conditions
- Cerebral Palsy, Upper Extremity Problem
- Being tested
- Action Observation Treatment, Virtual Rehabilitation
- Keywords
- cerebral palsy, upper extremity, virtual rehabilitation, action observation treatment
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action Observation TreatmentOther
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 RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Action Observation Treatment Receives: Other: Action Observation Treatment |
| Group 2 | Experimental | Virtual Rehabilitation Receives: Other: Virtual Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After 3 weeks of treatment (treatment is 15 sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individual with cerebral palsy will be assigned to group 1 or group 2 by simple randomization using the "Research Randomiser" program (http://www.randomizer.org/) prior to treatment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinem Erturan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sinem Erturan, Gazi University
- Investigators
- sinem erturan, MSc, Principal investigator, bulentelbasan@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327179
- Sponsor's protocol ID
- 2020 - 698
- Status last verified
- Apr 2022
- First submitted
- 7 Apr 2022
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Burak SE, Burak M, Elbasan B. Comparison of action observation therapy and virtual reality combined with conventional therapy for upper extremity rehabilitation in children with unilateral cerebral palsy. Braz J Phys Ther. 2026 Sep 5;30(5):101639. doi: 10.1016/j.bjpt.2026.101639. Online ahead of print.
PubMed 42700622
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Action Observation Therapy and Video-Based Play Therapy on the Upper Extremity and Trunk in Children With Unilateral Cerebral Palsy in the Framework of the International Classification of Functioning, Disability, and Health
- ClinicalTrials.gov ID
- NCT05327179
- Acronym / sponsor ID
- 2020 - 698
- Conditions
- Cerebral Palsy, Upper Extremity Problem
- Keywords
- cerebral palsy, upper extremity, virtual rehabilitation, action observation treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sinem ErturanUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cerebral Palsy (CP) defines a group of permanent disorders in the development of movement and posture that occur in the developing fetal and newborn brain, due to non-progressive disorders, leading to activity limitations. Unilateral CP (uCP) accounts for 38% of cases. These children complain of motor and sensory disorders that are more prominent on one side of the body, usually in the upper extremity (UE). These sensorimotor disorders typically limit their ability to perform activities of daily living, negatively affecting participation and quality of life. Therefore, in the last ten years, research on UE interventions for children with uCP has been focused on; While trying to develop existing methods, new treatment methods are tried to be created. There are various treatment modalities that aim to relieve UE function disorders and reduce activity limitations. It is very important to determine the most effective treatment method. However, there are few randomized controlled studies measuring clinical outcomes in children with uCP. New intervention strategies based on sound methodological and scientific foundations are needed.
It has been reported that motor learning is the basis of UE treatments applied in CP and reported to be effective. Based on neurophysiological findings, there are studies suggesting that AOT and VR treatment approaches accelerate the motor learning process. AOT; It includes observing selected UE actions and actively imitating the observed action. AOT has been previously used in the treatment of upper extremity in patients with chronic stroke, recovery of frostbite phenomenon in Parkinson's disease, treatment of lower and upper extremities in pediatric rehabilitation, and recovery of limb function after orthopedic surgery and has been reported in studies. Recent studies, especially in children with uCP, have reported promising results. In general, telerehabilitation is an effective, flexible, personalized and relatively cost-effective intervention, which strengthens the hypothesis that home rehabilitation services are a viable alternative to routine care. AOT can be easily performed at home as it is an approach based on careful observation and active imitation of actions. approach has been reported. Studies have reported that VR improves posture, balance, upper extremity function, and trunk control. There is no study in the literature examining the effects of motor learning-based AOT and VR applied at home on UE and body within the framework of international functionality, disability and health classification. Within the scope of the study, a contribution will be made to the literature, which has been reported to be insufficient in studies on UE treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Individual with cerebral palsy will be assigned to group 1 or group 2 by simple randomization using the "Research Randomiser" program (http://www.randomizer.org/) prior to treatment.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Action Observation TreatmentAction Observation Treatment |
| Group 2 | Experimental | Other: Virtual RehabilitationVirtual Rehabilitation |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Not volunteering to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Action Observation TreatmentAction 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. | Other | Group 1 |
| Virtual RehabilitationVirtual 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. | Other | Group 2 |
Primary outcome
Sociodemographic Data Form
Time frame: Before starting treatment
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
Joint Range of Motion (ROM) Measurement
Time frame: Before starting treatment
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.
Pediatric Quality of Life Inventory
Time frame: Before starting treatment
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.
The Jebsen Hand Function Test
Time frame: Before starting treatment
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
ABILHAND-Kids
Time frame: Before starting treatment
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.
The Quality of Upper Extremity Skills Test
Time frame: Before starting treatment
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
Selective Control of the Upper Extremity Scale
Time frame: Before starting treatment
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.
Trunk Control Measurement Scale
Time frame: Before starting treatment
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.
Gross grip strength
Time frame: Before starting treatment
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.
Pinch force
Time frame: Before starting treatment
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.
Childhood Health Assessment Questionaire
Time frame: Before starting treatment
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.
Sociodemographic Data Form
Time frame: After 3 weeks of treatment (treatment is 15 sessions)
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
Joint Range of Motion (ROM) Measurement
Time frame: After 3 weeks of treatment (treatment is 15 sessions)
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.
Pediatric Quality of Life Inventory
Time frame: After 3 weeks of treatment (treatment is 15 sessions)
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.
The Jebsen Hand Function Test
Time frame: After 3 weeks of treatment (treatment is 15 sessions)
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
ABILHAND-Kids
Time frame: After 3 weeks of treatment (treatment is 15 sessions)
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.
The Quality of Upper Extremity Skills Test
Time frame: After 3 weeks of treatment (treatment is 15 sessions)
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
Selective Control of the Upper Extremity Scale
Time frame: After 3 weeks of treatment (treatment is 15 sessions)
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.
Trunk Control Measurement Scale
Time frame: After 3 weeks of treatment (treatment is 15 sessions)
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.
Gross grip strength
Time frame: After 3 weeks of treatment (treatment is 15 sessions)
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.
Pinch force
Time frame: After 3 weeks of treatment (treatment is 15 sessions)
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.
Childhood Health Assessment Questionaire
Time frame: After 3 weeks of treatment (treatment is 15 sessions)
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Derived from this study: PubMed 42700622Burak SE, Burak M, Elbasan B. Comparison of action observation therapy and virtual reality combined with conventional therapy for upper extremity rehabilitation in children with unilateral cerebral palsy. Braz J Phys Ther. 2026 Sep 5;30(5):101639. doi: 10.1016/j.bjpt.2026.101639. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sinem erturan, MSc principal investigator
bulentelbasan@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action Observation Treatment and Virtual Rehabilitation in people with Cerebral Palsy and Upper Extremity Problem, run by Sinem Erturan at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sinem erturan, MSc (+905388557084, snm.ertrn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sociodemographic Data Form (time frame: Before starting treatment). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05327179, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.