NCT05327179

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

April 7, 2022

Last Update Submit

April 7, 2022

Conditions

Keywords

cerebral palsyupper extremityvirtual rehabilitationaction observation treatment

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

EXPERIMENTAL

Action Observation Treatment

Other: Action Observation Treatment

Group 2

EXPERIMENTAL

Virtual Rehabilitation

Other: Virtual 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.

Group 1

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.

Group 2

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Study Sites (1)

Gazi University

Ankara, None Selected, 06500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • sinem erturan, MSc

    bulentelbasan@gmail.com

    PRINCIPAL INVESTIGATOR

Central Study Contacts

sinem erturan, MSc

CONTACT

Bülent elbasan, prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
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

Locations