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The Effect of Action Observation Therapy on Balance in Patients With Cerebral Palsy

Primary Purpose

Cerebral Palsy, Exercise Therapy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
action observation
Sponsored by
Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring action observation therapy, balance

Eligibility Criteria

5 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Having been diagnosed with CP To be at I and II levels according to the Gross Motor Function Classification System Having bilateral and unilaterally affected spastic type CP Cooperating with assessments Absence of vision and hearing loss According to the health board report, only motor skills are affected Exclusion Criteria: Botulinum toxin application in the last 6 months Having had any surgical operation in the last 6 months Having dyskinetic, ataxic and hypotonic type CP Not attending treatment sessions regularly for 2 weeks Not participating in the pre- and post-treatment evaluation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    action observation therapy group

    control group

    Arm Description

    Children will watch the action observation therapy video on the computer screen placed 1 m in front of a chair in which they can sit comfortably, but they will not be allowed to move while watching the video. Children will watch the video of the exercise offered by the therapist and then practice the exercise. The watching time for each exercise is 3 minutes, and after watching 3 minutes, they will do the exercise in the video for 3 minutes.In order to increase the effectiveness of the action observation training. Children will be instructed to concentrate on the video at 1-minute intervals to allow children's attention span. The treatment program will be applied for 30 minutes, 5 days a week for 3 weeks. The first session of the exercise program will be held face-to-face and the other sessions will be followed online. Treatment will be started within the first 48 hours after the evaluation. After the applications, the evaluations at the beginning of the treatment will be repeated.

    Children with CP will watch the video on the computer screen placed 1 m in front of a chair in which they can sit comfortably, but they will not be allowed to move while watching the video. The therapist will explain the exercises verbally. Children will practice the exercise after watching cartoons. The watching time for each exercise is 3 minutes, and after watching 3 minutes of cartoons, they will do the exercise for 3 minutes. Children will be instructed to concentrate on the video at 1-minute intervals to allow children's attention span. The treatment program will be applied for 30 minutes, 5 days a week for 3 weeks. The first session of the exercise program will be held face-to-face and the other sessions will be followed online. Treatment will be started within the first 48 hours after the evaluation. After the applications, pre-treatment evaluations will be repeated.

    Outcomes

    Primary Outcome Measures

    Pediatric balance scale
    The pediatric balance scale is a modified version of the Berg balance scale and is used to evaluate the functional balance ability of school-age children. The scale consists of 14 items, scored from 0 (lowest function) to 4 (highest function), with a maximum score of 56.

    Secondary Outcome Measures

    Gross motor function classification system
    The Gross Motor Function Classification System (KMFSS) for CP is based on self-initiated movements with an emphasis on sitting, displacement and mobility. The main criterion when defining the five-level classification system is that the differences between the levels are meaningful in everyday life. General titles of each level LEVEL I: Walks without restrictions. LEVEL II: Walks with restrictions. LEVEL III: Walks using hand-held mobility devices. LEVEL IV: Self-movement is limited. Can use a motorized mobility vehicle. LEVEL V: Transported in a manual wheelchair.
    Gross motor function measurement-88
    Gross Motor Function Scale (GMFM-88) is divided into 5 main sections. It consists of a total of 88 items, 17 in the supine-prone position and turning section, 20 in the sitting section, 14 in the crawling-over-knee section, 13 in the standing section, and 24 in the walking-running-stair climbing section.
    Lower Extremity Selective Control Evaluation Scale (SCALE)
    The evaluation method currently used in the evaluation of selective motor control of the lower extremity is SCALE. Hip, knee, ankle, subtalar joint and toes bilaterally; It scores between 0-2 points.
    Trunk Impairment Scale
    The trunk impairment scale evaluates the trunk functionally in terms of strength in sitting position. The trunk impairment scale consists of three subsections: static, dynamic and coordination. The highest scores that can be obtained from the static, dynamic and coordination sub-headings are respectively; 7, 10 and 6 points. The total scale score ranges from 0 to 23.
    Pediatric Outcome Data Collection Instrument (PODCI)
    PODCI is one of the scales with proven validity and reliability, which is prepared for both children and adolescents, and is frequently used to determine functional status and evaluate health-related quality of life. The scale has 3 different forms; PODCI child form: The section consisting of 86 questions is filled by the families of children aged 6-10. PODCI adolescent family form: The section consisting of 86 questions is filled by the families of adolescents aged 11-18. PODCI adolescent form: The section consisting of 83 questions is filled by adolescents between the ages of 11-18. As a result, subscale standardized score "0" indicates worse health status and quality of life, "100" score indicates good health status and quality of life.
    Nintendo Wii-Fit Balance Score
    After the demographic information of the patient is saved in the device system, the patient is shown how to place his/her foot on the Nintendo Wii Fit balance board, the weight ratio given to the right and left feet (Body Center of Gravity right and left) is evaluated by asking him to stand on the balance board without moving, and the data is recorded as a percentage.
    Timed Get Up and Go Test (TUG)
    It is a valid and reliable method used to evaluate functional mobility and static and dynamic balance in CP. From a starting position with hips, knees, and ankles flexed to 90°, participants get up from a chair without arm support, walk 3 meters, return and sit in the chair. The time starts to be recorded with the "go" prompt given by the evaluator and is stopped when the hip touches the chair.
    Functional Near Infrared Spectroscopy (fNIRS) Application
    fNIRS is one of the new methods used in the measurement of local cerebral blood flow. It provides information about brain activity in the measured region using optical scattering and absorption of light at wavelengths close to infrared (700-950 nm).

    Full Information

    First Posted
    August 9, 2023
    Last Updated
    August 9, 2023
    Sponsor
    Medipol University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05995197
    Brief Title
    The Effect of Action Observation Therapy on Balance in Patients With Cerebral Palsy
    Official Title
    The Effect of Action Observation Therapy on Balance in Patients With Cerebral Palsy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    September 30, 2024 (Anticipated)
    Study Completion Date
    January 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    type of study: clinical trial the goal of this study is to learn about action observation therapy for cerebral palsy population. The main question it aim to answer is: Is action observation therapy effective on balance in children with cerebral palsy? Twenty-four children who met the inclusion criteria in the study will be randomly divided into two groups as the training group(action observation group) and the control group.
    Detailed Description
    The history and demographic information of all cases will be obtained.Action observation therapy will be applied to improve balance. The therapist will verbally explain the program to be applied to both groups. Children with CP will watch the video on the computer screen placed 1 m in front of a chair in which they can sit comfortably, but they will not be allowed to move while watching the video. Children with CP will watch the video of the exercise offered by the therapist and then practice the exercise. The watching time for each exercise is 3 minutes, and after watching 3 minutes, they will do the exercise in the video for 3 minutes. The control group will be shown cartoons. After 3 minutes of monitoring, each exercise will be studied for 3 minutes. In order to increase the effectiveness of the action observation training, the participants will watch the video at the designated time in a quiet and noiseless place. Children will be instructed to concentrate on the video at 1-minute intervals to allow children's attention span. The treatment program will be applied for 30 minutes, 5 days a week for 3 weeks. The first session of the exercise program will be held face-to-face and the other sessions will be followed online. Treatment will be started within the first 48 hours after the evaluation. After the applications, the evaluations at the beginning of the session will be repeated. Physiotherapy program to be applied: First week: Double-leg balancing on soft ground with eyes open, hands free Balance on both feet on soft ground with eyes closed, hands free Stand on one leg with eyes open on hard ground Stand on one leg on hard ground with eyes closed Second week: Standing with feet together on hard ground Standing in tandem on hard ground Right-left lower extremity weight transfer Step forward in standing position Third week: Standing with feet together on soft ground Standing in tandem on soft ground Taking steps in different directions in a standing position Kicking the ball with the foot Pre- and post-treatment fNIRS imaging will be used to measure the cerebral cortex blood supply of the participants. The registration will be taken from the fNIRS device (Medical Technologies LLC, Berlin, Germany) using the program NIRStar Acquisition (NIRx Medizintechnik GmbH, Germany). Records will be taken to scan the bilateral supplementary motor area over 8 sources and 4 receivers. NIRS registration will take place during action observation therapy and balance tests. In measuring balance with action observation therapy; Resting in sitting position for 20 seconds, watching action observation video while sitting for 20 seconds, standing on two legs on hard ground for 20 seconds, resting in sitting position for 20 seconds, will be repeated 6 times. For evaluation on soft ground, 20 seconds of resting on both feet with eyes open, 20 seconds of watching action observation video, 20 seconds of standing on two feet with eyes open, 20 seconds of resting on both feet with eyes open will be applied and fNIRS measurement will be performed by repeating 6 times. The same periods will be applied to the control group and a cartoon will be watched instead of the action observation video.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Palsy, Exercise Therapy
    Keywords
    action observation therapy, balance

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    action observation therapy group
    Arm Type
    Experimental
    Arm Description
    Children will watch the action observation therapy video on the computer screen placed 1 m in front of a chair in which they can sit comfortably, but they will not be allowed to move while watching the video. Children will watch the video of the exercise offered by the therapist and then practice the exercise. The watching time for each exercise is 3 minutes, and after watching 3 minutes, they will do the exercise in the video for 3 minutes.In order to increase the effectiveness of the action observation training. Children will be instructed to concentrate on the video at 1-minute intervals to allow children's attention span. The treatment program will be applied for 30 minutes, 5 days a week for 3 weeks. The first session of the exercise program will be held face-to-face and the other sessions will be followed online. Treatment will be started within the first 48 hours after the evaluation. After the applications, the evaluations at the beginning of the treatment will be repeated.
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    Children with CP will watch the video on the computer screen placed 1 m in front of a chair in which they can sit comfortably, but they will not be allowed to move while watching the video. The therapist will explain the exercises verbally. Children will practice the exercise after watching cartoons. The watching time for each exercise is 3 minutes, and after watching 3 minutes of cartoons, they will do the exercise for 3 minutes. Children will be instructed to concentrate on the video at 1-minute intervals to allow children's attention span. The treatment program will be applied for 30 minutes, 5 days a week for 3 weeks. The first session of the exercise program will be held face-to-face and the other sessions will be followed online. Treatment will be started within the first 48 hours after the evaluation. After the applications, pre-treatment evaluations will be repeated.
    Intervention Type
    Other
    Intervention Name(s)
    action observation
    Intervention Description
    cartoon observation
    Primary Outcome Measure Information:
    Title
    Pediatric balance scale
    Description
    The pediatric balance scale is a modified version of the Berg balance scale and is used to evaluate the functional balance ability of school-age children. The scale consists of 14 items, scored from 0 (lowest function) to 4 (highest function), with a maximum score of 56.
    Time Frame
    2 days before treatment and after 3 weeks
    Secondary Outcome Measure Information:
    Title
    Gross motor function classification system
    Description
    The Gross Motor Function Classification System (KMFSS) for CP is based on self-initiated movements with an emphasis on sitting, displacement and mobility. The main criterion when defining the five-level classification system is that the differences between the levels are meaningful in everyday life. General titles of each level LEVEL I: Walks without restrictions. LEVEL II: Walks with restrictions. LEVEL III: Walks using hand-held mobility devices. LEVEL IV: Self-movement is limited. Can use a motorized mobility vehicle. LEVEL V: Transported in a manual wheelchair.
    Time Frame
    2 days before treatment
    Title
    Gross motor function measurement-88
    Description
    Gross Motor Function Scale (GMFM-88) is divided into 5 main sections. It consists of a total of 88 items, 17 in the supine-prone position and turning section, 20 in the sitting section, 14 in the crawling-over-knee section, 13 in the standing section, and 24 in the walking-running-stair climbing section.
    Time Frame
    2 days before treatment and after 3 weeks
    Title
    Lower Extremity Selective Control Evaluation Scale (SCALE)
    Description
    The evaluation method currently used in the evaluation of selective motor control of the lower extremity is SCALE. Hip, knee, ankle, subtalar joint and toes bilaterally; It scores between 0-2 points.
    Time Frame
    2 days before treatment and after 3 weeks
    Title
    Trunk Impairment Scale
    Description
    The trunk impairment scale evaluates the trunk functionally in terms of strength in sitting position. The trunk impairment scale consists of three subsections: static, dynamic and coordination. The highest scores that can be obtained from the static, dynamic and coordination sub-headings are respectively; 7, 10 and 6 points. The total scale score ranges from 0 to 23.
    Time Frame
    2 days before treatment and after 3 weeks
    Title
    Pediatric Outcome Data Collection Instrument (PODCI)
    Description
    PODCI is one of the scales with proven validity and reliability, which is prepared for both children and adolescents, and is frequently used to determine functional status and evaluate health-related quality of life. The scale has 3 different forms; PODCI child form: The section consisting of 86 questions is filled by the families of children aged 6-10. PODCI adolescent family form: The section consisting of 86 questions is filled by the families of adolescents aged 11-18. PODCI adolescent form: The section consisting of 83 questions is filled by adolescents between the ages of 11-18. As a result, subscale standardized score "0" indicates worse health status and quality of life, "100" score indicates good health status and quality of life.
    Time Frame
    2 days before treatment and after 3 weeks
    Title
    Nintendo Wii-Fit Balance Score
    Description
    After the demographic information of the patient is saved in the device system, the patient is shown how to place his/her foot on the Nintendo Wii Fit balance board, the weight ratio given to the right and left feet (Body Center of Gravity right and left) is evaluated by asking him to stand on the balance board without moving, and the data is recorded as a percentage.
    Time Frame
    2 days before treatment and after 3 weeks
    Title
    Timed Get Up and Go Test (TUG)
    Description
    It is a valid and reliable method used to evaluate functional mobility and static and dynamic balance in CP. From a starting position with hips, knees, and ankles flexed to 90°, participants get up from a chair without arm support, walk 3 meters, return and sit in the chair. The time starts to be recorded with the "go" prompt given by the evaluator and is stopped when the hip touches the chair.
    Time Frame
    2 days before treatment and after 3 weeks
    Title
    Functional Near Infrared Spectroscopy (fNIRS) Application
    Description
    fNIRS is one of the new methods used in the measurement of local cerebral blood flow. It provides information about brain activity in the measured region using optical scattering and absorption of light at wavelengths close to infrared (700-950 nm).
    Time Frame
    2 days before treatment and after 3 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Having been diagnosed with CP To be at I and II levels according to the Gross Motor Function Classification System Having bilateral and unilaterally affected spastic type CP Cooperating with assessments Absence of vision and hearing loss According to the health board report, only motor skills are affected Exclusion Criteria: Botulinum toxin application in the last 6 months Having had any surgical operation in the last 6 months Having dyskinetic, ataxic and hypotonic type CP Not attending treatment sessions regularly for 2 weeks Not participating in the pre- and post-treatment evaluation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Melike Özipek
    Phone
    +905448704190
    Email
    melikesen67@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fatma Mutluay
    Phone
    +905333116782
    Email
    fmutluay@medipol.edu.tr

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    32907374
    Citation
    Abdelhaleem N, Taher S, Mahmoud M, Hendawy A, Hamed M, Mortada H, Magdy A, Raafat Ezz El-Din M, Zoukiem I, Elshennawy S. Effect of action observation therapy on motor function in children with cerebral palsy: a systematic review of randomized controlled trials with meta-analysis. Clin Rehabil. 2021 Jan;35(1):51-63. doi: 10.1177/0269215520954345. Epub 2020 Sep 9.
    Results Reference
    result
    PubMed Identifier
    32570855
    Citation
    Jeong YA, Lee BH. Effect of Action Observation Training on Spasticity, Gross Motor Function, and Balance in Children with Diplegia Cerebral Palsy. Children (Basel). 2020 Jun 18;7(6):64. doi: 10.3390/children7060064.
    Results Reference
    result
    PubMed Identifier
    32724782
    Citation
    Jung Y, Chung EJ, Chun HL, Lee BH. Effects of whole-body vibration combined with action observation on gross motor function, balance, and gait in children with spastic cerebral palsy: a preliminary study. J Exerc Rehabil. 2020 Jun 30;16(3):249-257. doi: 10.12965/jer.2040136.068. eCollection 2020 Jun.
    Results Reference
    result
    PubMed Identifier
    29764869
    Citation
    Sgandurra G, Cecchi F, Beani E, Mannari I, Maselli M, Falotico FP, Inguaggiato E, Perazza S, Sicola E, Feys H, Klingels K, Ferrari A, Dario P, Boyd RN, Cioni G. Tele-UPCAT: study protocol of a randomised controlled trial of a home-based Tele-monitored UPper limb Children Action observation Training for participants with unilateral cerebral palsy. BMJ Open. 2018 May 14;8(5):e017819. doi: 10.1136/bmjopen-2017-017819.
    Results Reference
    result
    PubMed Identifier
    32986904
    Citation
    Sgandurra G, Biagi L, Fogassi L, Ferrari A, Sicola E, Guzzetta A, Tosetti M, Cioni G. Reorganization of action observation and sensory-motor networks after action observation therapy in children with congenital hemiplegia: A pilot study. Dev Neurobiol. 2020 Sep;80(9-10):351-360. doi: 10.1002/dneu.22783. Epub 2020 Oct 28.
    Results Reference
    result

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    The Effect of Action Observation Therapy on Balance in Patients With Cerebral Palsy

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