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

NCT06069765 | Not Yet Recruiting DMC

• 1 other identifier: TrunkUpperExtremityPrograma
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cerebral Palsy Infantile; Chronic Pain; Upper Extremity Dysfunction

Keywords

compensation patterns; unilateral cerebral palsy

Outcome Measures

Primary Outcomes (1)

• Rate of variance of the Compensation patterns

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

  8 weeks

Secondary Outcomes (3)

• Intensity of pain

  8 weeks

• Location of pain

  8 weeks

• Bimanual ability

  8 weeks

Study Arms (2)

Standard group

NO INTERVENTION

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.

TUPEX group

EXPERIMENTAL

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

Other: TUPEX

Interventions

TUPEX OTHER

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.

TUPEX group

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Unilateral cerebral palsy diagnostic
• Level I or II of the Manual Ability Scale Classification

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacio Aspace Catalunya: lead
• Universitat Internacional de Catalunya: collaborator

Related Publications (6)

• 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.

  PMID: 33557483 RESULT

• 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.

  PMID: 30508221 RESULT

• 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). 2012 Aug;27(7):652-60. doi: 10.1016/j.clinbiomech.2012.04.001. Epub 2012 May 2.

  PMID: 22560625 RESULT

• 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.

  PMID: 34883885 RESULT

• 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.

  PMID: 34549424 RESULT

• 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.

  PMID: 24958005 RESULT

MeSH Terms

Conditions

Cerebral Palsy; Chronic Pain

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tamara Biedermann

  Aspace Catalunya

  STUDY CHAIR

Central Study Contacts

Georgina Domenech Garcia

CONTACT

+34 656707865; gdomenech@uic.es

Caritat Bagur Calafat

CONTACT

+34 656584779; cbagur@uic.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: October 6, 2023
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The research group expects to start sharing results at the end of 2024
• Access Criteria: Open