Cerebral PalsyNCT05849285
Evaluation of the Transitional and Lifelong Care Program
An observational study of Cerebral Palsy and Spina Bifida, run by Western University, Canada at 1 site in Canada.
Trial summary
The population cared for in the Transitional and Lifelong Care (TLC) clinic is youth and adults with childhood-onset disability, of which the large majority are adults with brain-based, neurodevelopmental conditions such as cerebral palsy, spina bifida and developmental disability. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cerebral Palsy, Spina Bifida, Developmental Disability
- What is being tested?
- TLC Clinic
- How many people
- 410 participants
- Where
- 1 siteCanada
- Study dates
- 3 Jan 2024to Dec 2027
- Phase
- Observational
- 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 21 years and older
- All sexes
- Adult, Older adult
Study population: Participants will be categorized into two cohorts: 1) patients of the TLC program, 2) controls . Participant dyads will be formed that include the adult patient (and a caregiver, spouse, or support person that may be involved in the patient's care. TLC dyads will be recruited from the existing client base of the program and control dyads will be recruited from the Kitchener/Waterloo/Cambridge area of Ontario (and the surrounding rural areas).
Who may be able to join
- Each participant dyad will consist of one person, of either sex and gender, who is over the age of 21 years with a childhood-onset disability, and the primary caregiver (based on contact hours) or support person, of either sex and gender, involved in their care. In cases where the patient participant is independent with care, a spouse or family member may still participate in the caregiver portion of the study.
- 2. Patient participants will have continuously resided in Ontario during the years of 2015 to 2020 to facilitate full data retrieval from the administrative dataset.
- 3. Healthcare providers, of any discipline, who provide care to adults with childhood-onset conditions in the TLC program.
Who cannot join
- Patient participants will be ineligible if they are in a phase of deterioration associated with a progressive health condition identified either personally or by the caregiver participant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Josh Wiener, MSc contact
Canada1 site, 1 recruiting
- Recruiting
Parkwood Institute
London, Ontario
Josh Wiener, MSc, jwiener2@uwo.ca
Caitlin Cassidy, MD, caitlin.cassidy@sjhc.london.on.ca
About this study
Official title: Evaluating a Model of Transitional and Lifelong Care for Adults With Childhood-Onset Disabilities
The population cared for in the Transitional and Lifelong Care (TLC) clinic is youth and adults with childhood-onset disability, of which the large majority are adults with brain-based, neurodevelopmental conditions such as cerebral palsy, spina bifida and developmental disability. The TLC program was created to address the health inequities that have long existed for this population because of the gaps in care they experience once they transition from pediatric healthcare services to the adult healthcare sector. The TLC program offers coordinated and comprehensive management of co-occurring mental, social and physical health conditions for this group of adults with neurodiverse conditions. The proposed study will provide much needed evaluation of the TLC model as an intervention to provide transitional and lifelong care that reduces the barriers experienced because of the undefined clinic path - potentially more appropriately referred to as a "cliff" by a Freeman et al., (2015) - for these individuals. With appropriate evidence of effectiveness, scaling of the TLC program to other Ontario Health regions and more widely across Canada would improve access healthcare providers who are knowledgeable and competent in the management of physical and mental health conditions for adults with neurodiverse conditions as well as service integration and coordination between social and health sectors. The TLC clinic was co-designed with adults with neurodiverse conditions and health care providers in 2014 and represents a significant and sustainable change in the way healthcare has been delivered for this population in the Ontario Health West region over the last 7 years. More than 750 people have accessed coordinated and comprehensive care from Physiatrists, a Nurse Practitioner, Social Worker, Physiotherapist, Occupational Therapist, Speech Language Pathologist, Registered Dietitian and Rehabilitation Therapist in the TLC program since it began, documenting the effectiveness of this care has the power to re-shape care received for adults with neurodiverse conditions that onset in childhood in Canada.
- Conditions
- Cerebral Palsy, Spina Bifida, Developmental Disability
- Being tested
- TLC Clinic
- Medical subject headings
- Cerebral Palsy, Spinal Dysraphism, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLC ClinicOther
Patients of the TLC clinic - receive coordinated multidisciplinary and specialized care from a team
| Study group | Role | What they receive |
|---|---|---|
| TLC Patient | Patients of the TLC program with CP/SB/DD Receives: Other: TLC Clinic | |
| Control Patient | Adults with CP/SB/DD that are not patients of the TLC Program | |
| TLC Caregiver | Caregiver of Patients of the TLC program with CP/SB/DD Receives: Other: TLC Clinic | |
| Control Caregiver | Caregiver of Adults with CP/SB/DD that are not patients of the TLC Program | |
| Healthcare Providers | Healthcare Providers who care for patients in the TLC clinic Receives: Other: TLC Clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
MPOC-A (Measure of Processes of Care - Adults) Each domain score, ranging from 0.0 to 7.0, is computed by averaging the ratings for the items of that domain, higher scores represent better outcomes
Measured: Year 1
Secondary outcomes (5)
Health Related Quality of Life (General)
EQ5D5L The five levels in each dimension are worded as (1) 'not /no problems', (2) 'slight problems', (3) 'moderate problems', (4) 'severe problems', and (5) 'unable to' (mobility, self-care, usual activities), 'extreme' (pain/depression), or 'extremely' (anxiety/depression). The descriptive system describes 3125 (=5⁵) potential health states.
Measured: Year 1
Health Related Quality of Life (WHO)
WHOQOL-BREF (World Health Organization Quality of Life - Brief) Lowest and highest possible scores to zero and 100, respectively. Higher scores represent better outcomes
Measured: Year 1
Caregiver Burden
BSFC (Burden Scale for Family Caregivers). Minimum score is 0, maximum score is 84, higher scores represent worse outcome (more burden).
Measured: Year 1
Perceived Support of Healthcare Providers
MPOC-SP (Measure of Processes of Care - Service Providers). Each domain score, ranging from 0.0 to 7.0, is computed by averaging the ratings for the items of that domain, higher scores represent better outcomes
Measured: Year 1
Economic Analysis
Unit Costs of healthcare used
Measured: Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start3 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- Prospective
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Brunton, Western University, Canada
- Investigators
- Laura K Brunton, PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849285
- Sponsor's protocol ID
- 122419
- Other IDs
- 184575
- Status last verified
- Feb 2026
- First submitted
- 25 Apr 2023
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified data will be available to share upon request made by other researchers once a plan of analysis has been proposed to the team
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Model of Transitional and Lifelong Care for Adults With Childhood-Onset Disabilities
- ClinicalTrials.gov ID
- NCT05849285
- Acronym / sponsor ID
- 122419
- Conditions
- Cerebral Palsy, Spina Bifida, Developmental Disability
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 May 2023 (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.
The population cared for in the Transitional and Lifelong Care (TLC) clinic is youth and adults with childhood-onset disability, of which the large majority are adults with brain-based, neurodevelopmental conditions such as cerebral palsy, spina bifida and developmental disability. The TLC program was created to address the health inequities that have long existed for this population because of the gaps in care they experience once they transition from pediatric healthcare services to the adult healthcare sector. The TLC program offers coordinated and comprehensive management of co-occurring mental, social and physical health conditions for this group of adults with neurodiverse conditions. The proposed study will provide much needed evaluation of the TLC model as an intervention to provide transitional and lifelong care that reduces the barriers experienced because of the undefined clinic path - potentially more appropriately referred to as a "cliff" by a Freeman et al., (2015) - for these individuals. With appropriate evidence of effectiveness, scaling of the TLC program to other Ontario Health regions and more widely across Canada would improve access healthcare providers who are knowledgeable and competent in the management of physical and mental health conditions for adults with neurodiverse conditions as well as service integration and coordination between social and health sectors. The TLC clinic was co-designed with adults with neurodiverse conditions and health care providers in 2014 and represents a significant and sustainable change in the way healthcare has been delivered for this population in the Ontario Health West region over the last 7 years. More than 750 people have accessed coordinated and comprehensive care from Physiatrists, a Nurse Practitioner, Social Worker, Physiotherapist, Occupational Therapist, Speech Language Pathologist, Registered Dietitian and Rehabilitation Therapist in the TLC program since it began, documenting the effectiveness of this care has the power to re-shape care received for adults with neurodiverse conditions that onset in childhood in Canada.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| TLC Patient | – | Other: TLC ClinicPatients of the TLC program with CP/SB/DD |
| Control Patient | – | –Adults with CP/SB/DD that are not patients of the TLC Program |
| TLC Caregiver | – | Other: TLC ClinicCaregiver of Patients of the TLC program with CP/SB/DD |
| Control Caregiver | – | –Caregiver of Adults with CP/SB/DD that are not patients of the TLC Program |
| Healthcare Providers | – | Other: TLC ClinicHealthcare Providers who care for patients in the TLC clinic |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants will be categorized into two cohorts: 1) patients of the TLC program, 2) controls . Participant dyads will be formed that include the adult patient (and a caregiver, spouse, or support person that may be involved in the patient's care. TLC dyads will be recruited from the existing client base of the program and control dyads will be recruited from the Kitchener/Waterloo/Cambridge area of Ontario (and the surrounding rural areas).
Key inclusion criteria (3 listed)
- Each participant dyad will consist of one person, of either sex and gender, who is over the age of 21 years with a childhood-onset disability, and the primary caregiver (based on contact hours) or support person, of either sex and gender, involved in their care. In cases where the patient participant is independent with care, a spouse or family member may still participate in the caregiver portion of the study.
- 2. Patient participants will have continuously resided in Ontario during the years of 2015 to 2020 to facilitate full data retrieval from the administrative dataset.
- 3. Healthcare providers, of any discipline, who provide care to adults with childhood-onset conditions in the TLC program.
Key exclusion criteria (1 listed)
- Patient participants will be ineligible if they are in a phase of deterioration associated with a progressive health condition identified either personally or by the caregiver participant.
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 |
|---|---|---|
| TLC ClinicPatients of the TLC clinic - receive coordinated multidisciplinary and specialized care from a team | Other | Healthcare Providers, TLC Caregiver, TLC Patient |
Primary outcome
Patient Satisfaction
Time frame: Year 1
MPOC-A (Measure of Processes of Care - Adults) Each domain score, ranging from 0.0 to 7.0, is computed by averaging the ratings for the items of that domain, higher scores represent better outcomes
5 secondary outcomes
Health Related Quality of Life (General)
Time frame: Year 1
Health Related Quality of Life (WHO)
Time frame: Year 1
Caregiver Burden
Time frame: Year 1
Perceived Support of Healthcare Providers
Time frame: Year 1
Economic Analysis
Time frame: Year 2
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 27 Feb 2026.
- Individual participant dataSharing planned: Undecided. De-identified data will be available to share upon request made by other researchers once a plan of analysis has been proposed to the team
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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.
Josh Wiener, MSc contact
Laura K Brunton, PhD principal investigator
Western University
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 Cerebral Palsy and Spina Bifida, run by Western University, Canada at 1 site in Canada.
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 1 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 27 Feb 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 Canada. 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 Laura K Brunton, PhD (15196612111 ext. 81501, lbrunto3@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction (time frame: Year 1). 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 27 Feb 2026.