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

February 12, 2025 updated by: Fundacio Aspace Catalunya

Trunk and Upper Extremities Program Effect in Decreasing Compensation Patterns in Unilateral Cerebral Palsy Children: Randomized Control Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Georgina Domenech Garcia
  • Phone Number: +34 656707865
  • Email: gdomenech@uic.es

Study Contact Backup

  • Name: Caritat Bagur Calafat
  • Phone Number: +34 656584779
  • Email: cbagur@uic.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: TUPEX group
Children in this group will continue with their daily activities and will add the TUPEX program during 8 weeks.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of variance of the Compensation patterns
Time Frame: 8 weeks
DeepLabCut (DLC) (Artificial Intelligence). Calculate the kinematic difference of the body marks during the activities
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensity of pain
Time Frame: 8 weeks
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.
8 weeks
Location of pain
Time Frame: 8 weeks
In the Body Diagram. The location of the pain is compared before and after the treatment
8 weeks
Bimanual ability
Time Frame: 8 weeks
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacio Aspace Catalunya

Collaborators

Universitat Internacional de Catalunya

Investigators

  • Study Chair: Tamara Biedermann, Aspace Catalunya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

September 19, 2023

First Submitted That Met QC Criteria

September 29, 2023

First Posted (Actual)

October 6, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 12, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TrunkUpperExtremityPrograma

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Pain

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe