Acquired Brain InjuryDIScover_PedNCT06804486
Exercise and Physical Activity in Children With Pediatric Acquired Brain Injury
A study testing Exercise and Recommendation to Deprescribe in people with Acquired Brain Injury, run by Universidade da Coruña at 1 site in Spain.
Trial summary
Exercise and physical activity in children with pediatric acquired brain injury Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- Exercise and Recommendation to Deprescribe
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2025to 28 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Niño Jesus Hospital
Madrid, Madrid, 28040
Andrea Gutierrez, 637592280, andreeagut@gmail.com
About this study
Exercise and physical activity in children with pediatric acquired brain injury
Read the 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.
- Conditions
- Acquired Brain Injury
- Being tested
- Exercise, Recommendation to Deprescribe
- Keywords
- PEDIATRIC ACQUIRED BRAIN INJURY, exercise, physical-sports activity, intervention
- Medical subject headings
- Brain Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called exercise and physical-sports activity
Exercise and physical-sports activity program
Recommendation to DeprescribeOther
Recommendation to Deprescribe
| Study group | Role | What they receive |
|---|---|---|
| active PEDIATRIC ACQUIRED BRAIN INJURY | Experimental | Not described Receives: Behavioral: Exercise; Other: Recommendation to Deprescribe |
| non active PEDIATRIC ACQUIRED BRAIN INJURY | No intervention | non active PEDIATRIC ACQUIRED BRAIN INJURY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related Quality of Life
Pediatric Quality of Life PedsQL
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Functional state: Balance
Berg Balance Scale and Timed Up and Go
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start1 Mar 2025
- Primary completion28 Jun 2027 (estimated)
- Study completion28 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade da Coruña
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Gutiérrez Suárez, Universidade da Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804486
- Sponsor's protocol ID
- DIScover_Pediatric
- Acronym
- DIScover_Ped
- Status last verified
- Oct 2026
- First submitted
- 23 Jan 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Physical Activity in Children With Pediatric Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT06804486
- Acronym / sponsor ID
- DIScover_Ped / DIScover_Pediatric
- Conditions
- Acquired Brain Injury
- Keywords
- PEDIATRIC ACQUIRED BRAIN INJURY, exercise, physical-sports activity, intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Universidade da CoruñaUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 28 Jun 2027 (estimated)
- Study completion
- 28 Jun 2027 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Exercise and physical activity in children with pediatric acquired brain injury
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active PEDIATRIC ACQUIRED BRAIN INJURY | Experimental | Behavioral: Exercise, Other: Recommendation to Deprescribe |
| non active PEDIATRIC ACQUIRED BRAIN INJURY | No intervention | –non active PEDIATRIC ACQUIRED BRAIN INJURY |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: exercise and physical-sports activityExercise and physical-sports activity program | Behavioural | active PEDIATRIC ACQUIRED BRAIN INJURY |
| Recommendation to DeprescribeRecommendation to Deprescribe | Other | active PEDIATRIC ACQUIRED BRAIN INJURY |
Primary outcome
Health-related Quality of Life
Time frame: Through study completion, an average of 1 year
Pediatric Quality of Life PedsQL
1 secondary outcome
Functional state: Balance
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Recommendation to Deprescribe in people with Acquired Brain Injury, run by Universidade da Coruña at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Gutierrez, PhD (+34 637592280, andrea.gutierrez@udc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related Quality of Life (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.