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

NCT ID: NCT06069765

Last Updated: 2025-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2027-07-31

Brief Summary

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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

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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.

Conditions

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Cerebral Palsy Infantile Chronic Pain Upper Extremity Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Standard group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

TUPEX group

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

Group Type EXPERIMENTAL

TUPEX

Intervention Type 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.

Interventions

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TUPEX

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitat Internacional de Catalunya

OTHER

Sponsor Role collaborator

Fundacio Aspace Catalunya

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tamara Biedermann

Role: STUDY_CHAIR

Aspace Catalunya

Central Contacts

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Georgina Domenech Garcia

Role: CONTACT

+34 656707865

Caritat Bagur Calafat

Role: CONTACT

+34 656584779

References

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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.

Reference Type RESULT
PMID: 33557483 (View on PubMed)

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.

Reference Type RESULT
PMID: 30508221 (View on PubMed)

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.

Reference Type RESULT
PMID: 22560625 (View on PubMed)

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.

Reference Type RESULT
PMID: 34883885 (View on PubMed)

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.

Reference Type RESULT
PMID: 34549424 (View on PubMed)

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.

Reference Type RESULT
PMID: 24958005 (View on PubMed)

Other Identifiers

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TrunkUpperExtremityPrograma

Identifier Type: -

Identifier Source: org_study_id

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