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NCT Number: NCT06069765

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

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.

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Key information

Conditions

Cerebral Palsy Infantile Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Chronic Pain Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Upper Extremity Dysfunction

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. Location of pain

    Time frame: 8 weeks

    In the Body Diagram. The location of the pain is compared before and after the treatment

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Caritat Bagur Calafat

CONTACT

[email protected]

+34 656584779

Georgina Domenech Garcia

CONTACT

[email protected]

+34 656707865

Sponsors and collaborators

Lead sponsor

Fundacio Aspace Catalunya

Other

Collaborators

  • Universitat Internacional de Catalunya

Registry information

Official study title

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

Acronym: TUPEX

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 6, 2023
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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