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

Sponsor

Fundacio Aspace Catalunya (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06069765

Collaborator

Universitat Internacional de Catalunya (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy Infantile Chronic Pain Upper Extremity Dysfunction	Other: TUPEX	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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.

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2026

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Rate of variance of the Compensation patterns [8 weeks]
DeepLabCut (DLC) (Artificial Intelligence). Calculate the kinematic difference of the body marks during the activities

Secondary Outcome Measures

Intensity of pain [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.
Location of pain [8 weeks]
In the Body Diagram. The location of the pain is compared before and after the treatment
Bimanual ability [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Fundacio Aspace Catalunya
Universitat Internacional de Catalunya

Investigators

Study Chair: Tamara Biedermann, Aspace Catalunya

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fundacio Aspace Catalunya

ClinicalTrials.gov Identifier:

NCT06069765

Other Study ID Numbers:

TrunkUpperExtremityPrograma

First Posted:

Oct 6, 2023

Last Update Posted:

Oct 11, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fundacio Aspace Catalunya

compensation patterns

unilateral cerebral palsy

Additional relevant MeSH terms:

Paralysis

Cerebral Palsy

Chronic Pain

Study Results

No Results Posted as of Oct 11, 2023