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

Not Applicable

Not yet recruiting

• Conditions: Cerebral Palsy Infantile; Upper Extremity Dysfunction; Chronic Pain
• Interventions: Other: TUPEX

• Registration Number: NCT06069765
• Lead Sponsor: Fundacio Aspace Catalunya

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.

Study Timeline

• Study First Submitted: 2023-09-19
• Study First Submitted QC: 2023-09-29
• Study First Posted: 2023-10-06
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14
• Study Start: 2025-09
• Primary Completion: 2027-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.