Exercise and Physical Activity in Children With Pediatric Acquired Brain Injury (DIScover_Ped)

August 18, 2025 updated by: Andrea Gutiérrez Suárez, Universidade da Coruña
Exercise and physical activity in children with pediatric acquired brain injury

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Although emerging approaches have emerged in the design of interventions that promote an orientation towards physical activity scientific evidence on their efficacy in this particular population remains limited. This underscores the need for further research to evaluate the efficacy of these intervention approaches in the context of pediatric ABI.

Study Type

Interventional

Enrollment (Estimated)

25

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 Locations

  • Spain
      • Madrid, Spain, 28040
        • Niño Jesus Hospital

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
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be under 18 years of age and present a medical diagnosis of pediatric acquired brain injury.
  • Have the informed consent completed and signed
  • Present a state that allows following indications for the practice of exercise and physical-sports activity.

Exclusion Criteria:

  • Have medical comorbidities that contraindicate the safe performance of the program (i.e., cardiac or respiratory instability, uncontrolled seizures).
  • Have additional disabling conditions, such as cognitive impairment and/or an inability to communicate with the researcher verbally, in writing, or through an emissary.
  • Non-attendance and/or non-collaboration at 70% of the sessions of the program.

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: active PEDIATRIC ACQUIRED BRAIN INJURY
Behavioral: Exercise
Exercise and physical-sports activity program
Other Names:
  • exercise and physical-sports activity
Other: Recommendation to Deprescribe
Recommendation to Deprescribe
No Intervention: non active PEDIATRIC ACQUIRED BRAIN INJURY

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: Through study completion, an average of 1 year
Pediatric Quality of Life PedsQL
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functionality
Time Frame: Through study completion, an average of 1 year
Berg Balance Scale and Timed Up and Go
Through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Universidade da Coruña

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 (Actual)

March 1, 2025

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

January 23, 2025

First Submitted That Met QC Criteria

January 29, 2025

First Posted (Actual)

February 3, 2025

Study Record Updates

Last Update Posted (Actual)

August 24, 2025

Last Update Submitted That Met QC Criteria

August 18, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIScover_Pediatric

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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