NCT06804486

Brief Summary

Exercise and physical activity in children with pediatric acquired brain injury

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
26 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

August 24, 2025

Status Verified

January 1, 2025

Enrollment Period

12 months

First QC Date

January 23, 2025

Last Update Submit

August 18, 2025

Conditions

Keywords

PEDIATRIC ACQUIRED BRAIN INJURYexercisephysical-sports activityintervention

Outcome Measures

Primary Outcomes (1)

  • Quality of Life

    Pediatric Quality of Life PedsQL

    Through study completion, an average of 1 year

Secondary Outcomes (1)

  • Functionality

    Through study completion, an average of 1 year

Study Arms (2)

active PEDIATRIC ACQUIRED BRAIN INJURY

EXPERIMENTAL
Behavioral: ExerciseOther: Recommendation to Deprescribe

non active PEDIATRIC ACQUIRED BRAIN INJURY

NO INTERVENTION

non active PEDIATRIC ACQUIRED BRAIN INJURY

Interventions

ExerciseBEHAVIORAL

Exercise and physical-sports activity program

Also known as: exercise and physical-sports activity
active PEDIATRIC ACQUIRED BRAIN INJURY

Recommendation to Deprescribe

active PEDIATRIC ACQUIRED BRAIN INJURY

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Niño Jesus Hospital

Madrid, Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Brain InjuriesMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 23, 2025

First Posted

February 3, 2025

Study Start

March 1, 2025

Primary Completion

February 28, 2026

Study Completion

February 28, 2026

Last Updated

August 24, 2025

Record last verified: 2025-01

Locations