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Trunk and Upper Extremities Program Effect in Decreasing Compensation Patterns in Unilateral Cerebral Palsy Children (TUPEX)

Primary Purpose

Cerebral Palsy Infantile, Chronic Pain, Upper Extremity Dysfunction

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TUPEX
Sponsored by
Fundacio Aspace Catalunya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cerebral Palsy Infantile focused on measuring compensation patterns, unilateral cerebral palsy

Eligibility Criteria

8 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Unilateral cerebral palsy diagnostic Level I or II of the Manual Ability Scale Classification Exclusion Criteria: Have received any intervention with botulinum toxin or shock waves in the previous six months or have them scheduled during the intervention Are undergoing treatment with intensive therapies. To have known alteration in the hips Have very serious attention or comprehension difficulties that prevent them from following instructions. Suffer uncontrolled epilepsies Suffer from severe visual problems.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Standard group

    TUPEX group

    Arm Description

    Children in this group will continue with their daily activities such as conventional physiotherapy and occupational therapy, even psychology, and their physical activities such as swimming or playing football.

    Children in this group will continue with their daily activities and will add the TUPEX program during 8 weeks.

    Outcomes

    Primary Outcome Measures

    Rate of variance of the Compensation patterns
    DeepLabCut (DLC) (Artificial Intelligence). Calculate the kinematic difference of the body marks during the activities

    Secondary Outcome Measures

    Intensity of pain
    Face Pain Scale - Revised (FPS-R). The face marked is compared before and after the treatment. 0 is the minimum scores, meaning no pain, and 10 is the maximum score, meaning really severe pain.
    Location of pain
    In the Body Diagram. The location of the pain is compared before and after the treatment
    Bimanual ability
    Children Hand-Use Experience Questionaire 2.0 (CHEQ 2.0). Whether they are more capable of doing more bimanual activities or not. The maximum score in each question is 100 and the minimum is 0. 100 means children use their hands like the neurotypical children, and 0 means they can't use the affected hand at all.

    Full Information

    First Posted
    September 19, 2023
    Last Updated
    October 9, 2023
    Sponsor
    Fundacio Aspace Catalunya
    Collaborators
    Universitat Internacional de Catalunya
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06069765
    Brief Title
    Trunk and Upper Extremities Program Effect in Decreasing Compensation Patterns in Unilateral Cerebral Palsy Children
    Acronym
    TUPEX
    Official Title
    Trunk and Upper Extremities Program Effect in Decreasing Compensation Patterns in Unilateral Cerebral Palsy Children: Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    July 2025 (Anticipated)
    Study Completion Date
    July 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fundacio Aspace Catalunya
    Collaborators
    Universitat Internacional de Catalunya

    4. Oversight

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

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to test the effectiveness of a trunk and upper extremities exercise program. The main questions it aims to answer are: Whether the program decreases compensation patterns in unilateral cerebral palsy children Whether the program decreases pain in unilateral cerebral palsy children Whether the program improves bimanual ability in unilateral cerebral palsy children Participants will undertake and 8-week program exercise at home If there is a comparison group: Researchers will compare with the control group to see if this program decreases compensation patterns.
    Detailed Description
    Children in control group will continue with their daily activities. Children in experimental group, apart from their daily activities, will undertake an 8-week program exercise at home for strengthening the trunk and the proximal part of both upper extremities. It contains 3 progressions that can be applied if needed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Palsy Infantile, Chronic Pain, Upper Extremity Dysfunction
    Keywords
    compensation patterns, unilateral cerebral palsy

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    One member of the research team responsible for carrying out the evaluations of the dependent variables and the collection of data carried out by the participant himself and/or his families, will remain blinded to the assignment of the participants to the study groups. In this sense, it is worth saying that the person responsible for carrying out the evaluations will do so only for the main variable, that is to say, he will be the one who will carry out the registration of the compensatory movements of the proximal part of the upper limb and trunk through the DLC . The secondary response variables are evaluated through self-administered scales and this same evaluator will be in charge of collecting the data provided by the families.
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard group
    Arm Type
    No Intervention
    Arm Description
    Children in this group will continue with their daily activities such as conventional physiotherapy and occupational therapy, even psychology, and their physical activities such as swimming or playing football.
    Arm Title
    TUPEX group
    Arm Type
    Experimental
    Arm Description
    Children in this group will continue with their daily activities and will add the TUPEX program during 8 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    TUPEX
    Intervention Description
    This program contains exercises with their own body weight or with Thera-bands for gaining strength in their shoulder and trunk muscles. It contains some progression exercise if needed. Each session can last between 20 and 30 minutes. Children have to do each session three times a week during 8 weeks.
    Primary Outcome Measure Information:
    Title
    Rate of variance of the Compensation patterns
    Description
    DeepLabCut (DLC) (Artificial Intelligence). Calculate the kinematic difference of the body marks during the activities
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Intensity of pain
    Description
    Face Pain Scale - Revised (FPS-R). The face marked is compared before and after the treatment. 0 is the minimum scores, meaning no pain, and 10 is the maximum score, meaning really severe pain.
    Time Frame
    8 weeks
    Title
    Location of pain
    Description
    In the Body Diagram. The location of the pain is compared before and after the treatment
    Time Frame
    8 weeks
    Title
    Bimanual ability
    Description
    Children Hand-Use Experience Questionaire 2.0 (CHEQ 2.0). Whether they are more capable of doing more bimanual activities or not. The maximum score in each question is 100 and the minimum is 0. 100 means children use their hands like the neurotypical children, and 0 means they can't use the affected hand at all.
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Unilateral cerebral palsy diagnostic Level I or II of the Manual Ability Scale Classification Exclusion Criteria: Have received any intervention with botulinum toxin or shock waves in the previous six months or have them scheduled during the intervention Are undergoing treatment with intensive therapies. To have known alteration in the hips Have very serious attention or comprehension difficulties that prevent them from following instructions. Suffer uncontrolled epilepsies Suffer from severe visual problems.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Georgina Domenech Garcia
    Phone
    +34 656707865
    Email
    gdomenech@uic.es
    First Name & Middle Initial & Last Name or Official Title & Degree
    Caritat Bagur Calafat
    Phone
    +34 656584779
    Email
    cbagur@uic.es
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tamara Biedermann
    Organizational Affiliation
    Aspace Catalunya
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The results could be submitted for publication in Clinical Rehabilitation, Therapeutic Advances in Chronic Disease, Acta Pediatrics or in Developmental Medicine & Child Neurology (DMCN). It is also planned to disseminate the knowledge obtained to different associations in the field of physiotherapy in pediatrics such as the Spanish Association of Intervention in the Early Childhood (AEIPI) and the Spanish Pediatric Association (AEP) or Association of Infantile Hemiparesis. Regarding the presentation at congresses, it is planned to present the results of this study at the annual congress of the European Academy of Childhood Disability, that of the Spanish Society of Child Rehabilitation or the National Congress of Rehabilitation.
    IPD Sharing Time Frame
    The research group expects to start sharing results at the end of 2024
    IPD Sharing Access Criteria
    Open
    Citations:
    PubMed Identifier
    33557483
    Citation
    Abd-Elfattah HM, Aly SM. Effect of Core Stability Exercises on Hand Functions in Children With Hemiplegic Cerebral Palsy. Ann Rehabil Med. 2021 Feb;45(1):71-78. doi: 10.5535/arm.20124. Epub 2021 Feb 9.
    Results Reference
    result
    PubMed Identifier
    30508221
    Citation
    Mckinnon CT, Meehan EM, Harvey AR, Antolovich GC, Morgan PE. Prevalence and characteristics of pain in children and young adults with cerebral palsy: a systematic review. Dev Med Child Neurol. 2019 Mar;61(3):305-314. doi: 10.1111/dmcn.14111. Epub 2018 Dec 3.
    Results Reference
    result
    PubMed Identifier
    22560625
    Citation
    Brochard S, Lempereur M, Mao L, Remy-Neris O. The role of the scapulo-thoracic and gleno-humeral joints in upper-limb motion in children with hemiplegic cerebral palsy. Clin Biomech (Bristol, Avon). 2012 Aug;27(7):652-60. doi: 10.1016/j.clinbiomech.2012.04.001. Epub 2012 May 2.
    Results Reference
    result
    PubMed Identifier
    34883885
    Citation
    Francisco-Martinez C, Prado-Olivarez J, Padilla-Medina JA, Diaz-Carmona J, Perez-Pinal FJ, Barranco-Gutierrez AI, Martinez-Nolasco JJ. Upper Limb Movement Measurement Systems for Cerebral Palsy: A Systematic Literature Review. Sensors (Basel). 2021 Nov 26;21(23):7884. doi: 10.3390/s21237884.
    Results Reference
    result
    PubMed Identifier
    34549424
    Citation
    Jackman M, Sakzewski L, Morgan C, Boyd RN, Brennan SE, Langdon K, Toovey RAM, Greaves S, Thorley M, Novak I. Interventions to improve physical function for children and young people with cerebral palsy: international clinical practice guideline. Dev Med Child Neurol. 2022 May;64(5):536-549. doi: 10.1111/dmcn.15055. Epub 2021 Sep 21.
    Results Reference
    result
    PubMed Identifier
    24958005
    Citation
    Novak I. Evidence-based diagnosis, health care, and rehabilitation for children with cerebral palsy. J Child Neurol. 2014 Aug;29(8):1141-56. doi: 10.1177/0883073814535503. Epub 2014 Jun 22.
    Results Reference
    result

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    Trunk and Upper Extremities Program Effect in Decreasing Compensation Patterns in Unilateral Cerebral Palsy Children

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