Spina BifidaNCT07706517
Assessing Transition Practices for Children With Disabilities: Pathways to a Successful Adulthood
An observational study of Spina Bifida and Cerebral Palsy, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Transition to adult care is a purposeful and structured movement of youth with complex disabilities from child centered to adult oriented services. This complex and potentially challenging period requires careful planning. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Spina Bifida, Cerebral Palsy, Spinal Cord Injury
- What is being tested?
- Chart review and Semi-structured interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 128 participants
- Where
- 1 siteFrance
- Study dates
- 14 Feb 2025to 10 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will be based on a cohort of patients treated in the pediatric physical medicine and rehabilitation department at Saint-Étienne University Hospital between 2012 and 2022.
Who may be able to join
- patients who had been diagnosed with conditions such as cerebral palsy, neonatal stroke, polyhandicap, spinal cord injury, spina bifida, or other genetic syndromes.
- patients who had visited the pediatric rehabilitation department at least once between 2012 and 2022.
Who cannot join
- neuromuscular disorders,
- any cancer diagnoses,
- autism spectrum disorders,
- patients still in pediatric care,
Trial locations and contacts
1 site in 1 country.
About this study
Transition to adult care is a purposeful and structured movement of youth with complex disabilities from child centered to adult oriented services.
This complex and potentially challenging period requires careful planning.
The investigators aim to examine the transition practices in the University Hospital of Saint Etienne. The study employs a mixed methods approach, combining:
- A retrospective evaluation : Analyzing transition data over a 10-year period.
- A prospective qualitative study : Conducting semi-structured interviews with patients who have already transitioned within our clinic.
Read the detailed description
The aim of this study is to assess how transition from pediatric to adult care is currently managed within a university hospital center. By examining existing practices and gathering the perspectives of young people and their families, the investigators sought to identify both the strengths of the current system and the areas where improvements are needed to ensure a smoother, more effective transition process.
- Conditions
- Spina Bifida, Cerebral Palsy, Spinal Cord Injury, Spastic Paraplegia, Stroke
- Being tested
- Chart review, Semi-structured interview
- Keywords
- Transition to adult care, Adolescent care, disability, rehabilitation
- Medical subject headings
- Spinal Dysraphism, Cerebral Palsy, Spinal Cord Injuries, Paraplegia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chart reviewOther
Chart review of adults who had been followed in the pediatric PM\&R department and who should have already completed their transition to adult care.
Semi-structured interviewBehavioural
The qualitative approach was designed to explore patient's related experience of the transition process, with a focus on how they perceived, interpreted, and navigated their journey from pediatric to adult care.
| Study group | Role | What they receive |
|---|---|---|
| Transition to adulthood | All patients from pediatric Physical Medicine and Rehabilitation (PM\&R) department database with at least one hospitalisation (day or week) from 2012 to 2022 over 15 years old Receives: Other: Chart review; Behavioral: Semi-structured interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of follow-up following transfer of care.
The absence of follow up discontinuity is based on the major indicator retained from the Suris et al Delphi study on key elements of a successful transition, which is "patient not lost to follow up".
Thus by calculating the delay between the last pediatric visit and the first adult visit.
Measured: One year after the last pediatric visit.
Secondary outcomes (4)
Number of follow-up following transfer of care.
The absence of follow up discontinuity is based on the major indicator retained from the Suris et al Delphi study on key elements of a successful transition, which is "patient not lost to follow up".
Thus by calculating the delay between the last pediatric visit and the first adult visit.
Measured: Two years after the last pediatric visit.
Key Themes and Narratives (semi-structured interviews)
The identification and detailed description of key themes and patterns emerging from the semi-structured interviews. This will involve a rigorous thematic analysis of young adults' narratives, capturing their lived experiences, perceptions, and emotional responses during the transition from child-centered to adult-oriented healthcare. The analysis will illuminate the core elements of their transition journey, providing a rich understanding of their challenges, successes, and perspectives.
Measured: At inclusion
The Transition Readiness Assessment Questionnaire (TRAQ)
It is a validated self-report tool designed to assess the preparedness of adolescents and young adults with chronic health conditions for the transition from pediatric to adult health care services .
Scores are interpreted on a 5-point Likert scale (from 0 to 5), where higher scores reflect greater autonomy and readiness for transition.
Measured: At inclusion
Polyhandicap quality of life questionnaire (PolyQol).
It is designed to assess the quality of life of individuals with polyhandicap. It covers key domains such as physical well-being, communication, emotional state, autonomy, and participation. Items are scored on a Likert-type scale (total score ranging from 20 to100), with higher scores reflecting better perceived quality of life
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start14 Feb 2025
- Primary completion10 Sep 2025
- Study completion10 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spina BifidaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria ZAKHEM, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706517
- Sponsor's protocol ID
- IRBN082025/CHUSTE
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Transition Practices for Children With Disabilities: Pathways to a Successful Adulthood
- ClinicalTrials.gov ID
- NCT07706517
- Acronym / sponsor ID
- IRBN082025/CHUSTE
- Conditions
- Spina Bifida, Cerebral Palsy, Spinal Cord Injury, Spastic Paraplegia, Stroke
- Keywords
- Transition to adult care, Adolescent care, disability, rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 15 Jul 2026 (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.
Transition to adult care is a purposeful and structured movement of youth with complex disabilities from child centered to adult oriented services.
This complex and potentially challenging period requires careful planning.
The investigators aim to examine the transition practices in the University Hospital of Saint Etienne. The study employs a mixed methods approach, combining:
- A retrospective evaluation : Analyzing transition data over a 10-year period.
- A prospective qualitative study : Conducting semi-structured interviews with patients who have already transitioned within our clinic.
Detailed description
The aim of this study is to assess how transition from pediatric to adult care is currently managed within a university hospital center. By examining existing practices and gathering the perspectives of young people and their families, the investigators sought to identify both the strengths of the current system and the areas where improvements are needed to ensure a smoother, more effective transition process.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transition to adulthood | – | Other: Chart review, Behavioral: Semi-structured interviewAll patients from pediatric Physical Medicine and Rehabilitation (PM\&R) department database with at least one hospitalisation (day or week) from 2012 to 2022 over 15 years old |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will be based on a cohort of patients treated in the pediatric physical medicine and rehabilitation department at Saint-Étienne University Hospital between 2012 and 2022.
Key inclusion criteria (2 listed)
- patients who had been diagnosed with conditions such as cerebral palsy, neonatal stroke, polyhandicap, spinal cord injury, spina bifida, or other genetic syndromes.
- patients who had visited the pediatric rehabilitation department at least once between 2012 and 2022.
Key exclusion criteria (4 listed)
- neuromuscular disorders,
- any cancer diagnoses,
- autism spectrum disorders,
- patients still in pediatric care,
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 |
|---|---|---|
| Chart reviewChart review of adults who had been followed in the pediatric PM\&R department and who should have already completed their transition to adult care. | Other | Transition to adulthood |
| Semi-structured interviewThe qualitative approach was designed to explore patient's related experience of the transition process, with a focus on how they perceived, interpreted, and navigated their journey from pediatric to adult care. | Behavioural | Transition to adulthood |
Primary outcome
Number of follow-up following transfer of care.
Time frame: One year after the last pediatric visit.
The absence of follow up discontinuity is based on the major indicator retained from the Suris et al Delphi study on key elements of a successful transition, which is "patient not lost to follow up". Thus by calculating the delay between the last pediatric visit and the first adult visit.
4 secondary outcomes
Number of follow-up following transfer of care.
Time frame: Two years after the last pediatric visit.
Key Themes and Narratives (semi-structured interviews)
Time frame: At inclusion
The Transition Readiness Assessment Questionnaire (TRAQ)
Time frame: At inclusion
Polyhandicap quality of life questionnaire (PolyQol).
Time frame: At inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Maria ZAKHEM, MD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spina Bifida and Cerebral Palsy, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 16 Jul 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of follow-up following transfer of care. (time frame: One year after the last pediatric visit.). 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 16 Jul 2026.