Traumatic Brain InjuryNCT05022940
Functional Evolution of Traumatic Brain Injured Adults During Rehabilitation and Social Participation
An observational study of Traumatic Brain Injury, run by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal at 1 site in Canada.
Trial summary
The research project aims to better understand the multiple factors related to the clinical evolution and the social participation of traumatic brain injured (TBI). The project will provide better understanding of the patients' evolution during rehabilitation after TBI in terms of adaptation and social participation… Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Usual gold-standard multidisciplinary rehabilitation for TBI
- How many people
- 1,500 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2017to 1 Jun 2026
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals with a mild, moderate or severe TBI who are referred and registered in a multidisciplinary holistic rehabilitation program.
Who may be able to join
- All adult TBI patients receiving post-acute rehabilitation services.
Who cannot join
- TBI patients that do not complete at least one month of rehabilitation.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CRIR
Montreal, Quebec, H3S1M9
Michelle McKerral, 5148678170, michelle.mckerral@umontreal.ca
About this study
Official title: Functional Evolution of Traumatic Brain Injured Adults During Rehabilitation and Social Participation: a Continuum of Care to Community Study
The research project aims to better understand the multiple factors related to the clinical evolution and the social participation of traumatic brain injured (TBI). The project will provide better understanding of the patients' evolution during rehabilitation after TBI in terms of adaptation and social participation, assess the effect of rehabilitation and study social participation outcomes and quality of life of TBI patients one-year post-rehabilitation. Project benefits include improvement of clinical practices and support in decision-making.
The objectives of this research project are:
Read more
Part 1: To provide a picture of the evolution, in terms of social adaptation and participation of patients during rehabilitation after a TBI.
Part 2: To study social participation outcomes and quality of life of TBI individuals one year after the end of their rehabilitation.
Read the detailed description
Context: This clinical research project is part of a series of innovative approaches to knowledge transfer in the field of trauma care funded by the Institut national d'excellence en santé et en services sociaux (INESSS) that have been recently conducted by 5 rehabilitation centers and which laid the groundwork for a culture of systematic measurement of clinical and functional evolution during rehabilitation and of social participation outcomes of Quebec adults with a traumatic brain injury (TBI). The Mayo-Portland Adaptability Inventory-4, or MPAI-4, which has three short scales: Abilities (12 items), Adaptation (12 items), Participation (8 items) giving specific indexes to each of these three dimensions, as well as a total score reflecting the general level of adaptation/social participation, was implemented in all the TBI rehabilitation programs within the trauma care continuum of greater Montreal (5 rehabilitation sites). These new practices allow to carry out original and rigorous prospective studies in order to better understand the multiple factors related to the clinical evolution of individuals who have sustained a TBI.
Objectives: Objective 1- To provide a picture of the evolution, in terms of social adaptation/participation, of a multicenter patient cohort in rehabilitation following TBI, according to their rehabilitation pathway (inpatient-outpatient, outpatient only); Objective Objective 2- To study social participation outcomes and quality of life of TBI individuals one year after the end of their rehabilitation.
Methodology: MPAI-4 data will be obtained for all patients at start and end of rehabilitation, and they will be subsequently contacted by phone one year after the end of their rehabilitation to administer the MPAI-4 Participation scale and QOLIBRI, measuring quality of life. At the end of the project, at least 1,500 unique patient cases will have been integrated into the study. For the one-year post-rehabilitation follow-up of the subjects included in the database we estimate the loss at 30% maximum; we expect to be able to collect post-rehabilitation data from a minimum of 700 patients who have completed rehabilitation. The raw data will be subjected to quantitative statistical analyzes to meet different objectives: ANOVAs to compare start-to-end rehabilitation measurement times for the different rehabilitation pathways; ANCOVA to compare groups on the total score and the three MPAI-4 scales at the end of rehabilitation, with scores at rehabilitation start as covariates; ANCOVA to compare the two groups on the Participation scale and QOLIBRI at the one-year follow-up with scores at rehabilitation start as covariates. Regression analyses will also be performed to determine which sociodemographic and clinical variables are most closely related to MPAI-4 and QOLIBRI scores.
Expected impacts: This innovative study will provide an unprecedented portrait of social participation and clinical evolution during rehabilitation within the continuum of trauma care services for a large cohort of adults (young adults, middle-aged adults, seniors) who sustained a TBI. This will provide evidence that will improve practices and support decision-making related to the organization of services. The systematic use of MPAI-4 may also help to assess the effects of changes in rehabilitation practices (eg, when implementing TBI practice guidelines). The various actors involved in this project and who will form the Monitoring committee will ensure the multiple benefits and impacts of the project.
- Conditions
- Traumatic Brain Injury
- Being tested
- Usual gold-standard multidisciplinary rehabilitation for TBI
- Keywords
- Social participation, Quality of life
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual gold-standard multidisciplinary rehabilitation for TBIOther
In individual and group interventions within a holistic interdisciplinary rehabilitation program focusing on resumption of daily activities and social roles. Interventions could include physiotherapy or physical training, occupational therapy, speech therapy, and neuropsychology/psychology, which aimed at reducing the impacts of cognitive difficulties in daily life by using self-guided and environmental strategies.
| Study group | Role | What they receive |
|---|---|---|
| TBI rehabilitation | All individuals with mild, moderate or severe TBI registered into rehabilitation. Receives: Other: Usual gold-standard multidisciplinary rehabilitation for TBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from start of rehabilitation baseline (T0) Mayo-Portland Adaptability Inventory-4 (MPAI-4) at end of rehabilitation (post-intervention - T1)
The MPAI-4 has 29 scored items and each item is scored on a 5-point scale (from 0 to 4). There are three subscales: Abilities (12 scored items, 0-47 after adjusting scores), Adjustment (9 scored items, 0-46 after adjusting scores), Participation (8 scored items, 0-30 after adjusting scores) giving specific indexes to each of these three dimensions, as well as a total score (all 29 items, 0-111) reflecting the general level of adaptation/social participation. As three items contribute to both the Adjustment and the Participation scales, the total score is less than the sum of the three subscales. Higher scores mean worse outcome.
Measured: Start to end of rehabilitation, an average of 1 year (pre-post rehabilitation - T0-T1)
Change from end of rehabilitation (T1) Mayo-Portland Adaptability Inventory-4 (MPAI-4) at 1-year post-rehabilitation (follow-up -T2)
The MPAI-4 has 29 scored items and each item is scored on a 5-point scale (from 0 to 4). There are three subscales: Abilities (12 scored items, 0-47 after adjusting scores), Adjustment (9 scored items, 0-46 after adjusting scores), Participation (8 scored items, 0-30 after adjusting scores) giving specific indexes to each of these three dimensions, as well as a total score (all 29 items, 0-111) reflecting the general level of adaptation/social participation. As three items contribute to both the Adjustment and the Participation scales, the total score is less than the sum of the three subscales. Higher scores mean worse outcome.
Measured: 1 year post-rehabilitation (post-rehabilitation to 1-year follow-up - T1-T2)
Quality of Life after Brain Injury (QOLIBRI) status at 1-year post-rehabilitation
The MPAI-4 has 29 scored items and each item is scored on a 5-point scale (from 0 to 4). There are three subscales: Abilities (12 scored items, 0-47 after adjusting scores), Adjustment (9 scored items, 0-46 after adjusting scores), Participation (8 scored items, 0-30 after adjusting scores) giving specific indexes to each of these three dimensions, as well as a total score (all 29 items, 0-111) reflecting the general level of adaptation/social participation. As three items contribute to both the Adjustment and the Participation scales, the total score is less than the sum of the three subscales. Higher scores mean worse outcome.
Measured: 1-year post-rehabilitation (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start1 Jun 2017
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec
- Responsible party
- Principal investigator, Michelle McKerral, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
- Investigators
- Michelle McKerral, PhD, Principal investigator, CRIR-IURDPM-CCSMTL and Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022940
- Sponsor's protocol ID
- CRIR MMcK 2
- Status last verified
- Aug 2024
- First submitted
- 17 Aug 2021
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Evolution of Traumatic Brain Injured Adults During Rehabilitation and Social Participation: a Continuum of Care to Community Study
- ClinicalTrials.gov ID
- NCT05022940
- Acronym / sponsor ID
- CRIR MMcK 2
- Conditions
- Traumatic Brain Injury
- Keywords
- Social participation, Quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Centre for Interdisciplinary Research in Rehabilitation of Greater MontrealUniversity, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 26 Aug 2021 (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 research project aims to better understand the multiple factors related to the clinical evolution and the social participation of traumatic brain injured (TBI). The project will provide better understanding of the patients' evolution during rehabilitation after TBI in terms of adaptation and social participation, assess the effect of rehabilitation and study social participation outcomes and quality of life of TBI patients one-year post-rehabilitation. Project benefits include improvement of clinical practices and support in decision-making.
The objectives of this research project are:
Part 1: To provide a picture of the evolution, in terms of social adaptation and participation of patients during rehabilitation after a TBI.
Part 2: To study social participation outcomes and quality of life of TBI individuals one year after the end of their rehabilitation.
Detailed description
Context: This clinical research project is part of a series of innovative approaches to knowledge transfer in the field of trauma care funded by the Institut national d'excellence en santé et en services sociaux (INESSS) that have been recently conducted by 5 rehabilitation centers and which laid the groundwork for a culture of systematic measurement of clinical and functional evolution during rehabilitation and of social participation outcomes of Quebec adults with a traumatic brain injury (TBI). The Mayo-Portland Adaptability Inventory-4, or MPAI-4, which has three short scales: Abilities (12 items), Adaptation (12 items), Participation (8 items) giving specific indexes to each of these three dimensions, as well as a total score reflecting the general level of adaptation/social participation, was implemented in all the TBI rehabilitation programs within the trauma care continuum of greater Montreal (5 rehabilitation sites). These new practices allow to carry out original and rigorous prospective studies in order to better understand the multiple factors related to the clinical evolution of individuals who have sustained a TBI.
Objectives: Objective 1- To provide a picture of the evolution, in terms of social adaptation/participation, of a multicenter patient cohort in rehabilitation following TBI, according to their rehabilitation pathway (inpatient-outpatient, outpatient only); Objective Objective 2- To study social participation outcomes and quality of life of TBI individuals one year after the end of their rehabilitation.
Methodology: MPAI-4 data will be obtained for all patients at start and end of rehabilitation, and they will be subsequently contacted by phone one year after the end of their rehabilitation to administer the MPAI-4 Participation scale and QOLIBRI, measuring quality of life. At the end of the project, at least 1,500 unique patient cases will have been integrated into the study. For the one-year post-rehabilitation follow-up of the subjects included in the database we estimate the loss at 30% maximum; we expect to be able to collect post-rehabilitation data from a minimum of 700 patients who have completed rehabilitation. The raw data will be subjected to quantitative statistical analyzes to meet different objectives: ANOVAs to compare start-to-end rehabilitation measurement times for the different rehabilitation pathways; ANCOVA to compare groups on the total score and the three MPAI-4 scales at the end of rehabilitation, with scores at rehabilitation start as covariates; ANCOVA to compare the two groups on the Participation scale and QOLIBRI at the one-year follow-up with scores at rehabilitation start as covariates. Regression analyses will also be performed to determine which sociodemographic and clinical variables are most closely related to MPAI-4 and QOLIBRI scores.
Expected impacts: This innovative study will provide an unprecedented portrait of social participation and clinical evolution during rehabilitation within the continuum of trauma care services for a large cohort of adults (young adults, middle-aged adults, seniors) who sustained a TBI. This will provide evidence that will improve practices and support decision-making related to the organization of services. The systematic use of MPAI-4 may also help to assess the effects of changes in rehabilitation practices (eg, when implementing TBI practice guidelines). The various actors involved in this project and who will form the Monitoring committee will ensure the multiple benefits and impacts of the project.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TBI rehabilitation | – | Other: Usual gold-standard multidisciplinary rehabilitation for TBIAll individuals with mild, moderate or severe TBI registered into rehabilitation. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals with a mild, moderate or severe TBI who are referred and registered in a multidisciplinary holistic rehabilitation program.
Key inclusion criteria (1 listed)
- All adult TBI patients receiving post-acute rehabilitation services.
Key exclusion criteria (1 listed)
- TBI patients that do not complete at least one month of rehabilitation.
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 |
|---|---|---|
| Usual gold-standard multidisciplinary rehabilitation for TBIIn individual and group interventions within a holistic interdisciplinary rehabilitation program focusing on resumption of daily activities and social roles. Interventions could include physiotherapy or physical training, occupational therapy, speech therapy, and neuropsychology/psychology, which aimed at reducing the impacts of cognitive difficulties in daily life by using self-guided and environmental strategies. | Other | TBI rehabilitation |
Primary outcome
Change from start of rehabilitation baseline (T0) Mayo-Portland Adaptability Inventory-4 (MPAI-4) at end of rehabilitation (post-intervention - T1)
Time frame: Start to end of rehabilitation, an average of 1 year (pre-post rehabilitation - T0-T1)
The MPAI-4 has 29 scored items and each item is scored on a 5-point scale (from 0 to 4). There are three subscales: Abilities (12 scored items, 0-47 after adjusting scores), Adjustment (9 scored items, 0-46 after adjusting scores), Participation (8 scored items, 0-30 after adjusting scores) giving specific indexes to each of these three dimensions, as well as a total score (all 29 items, 0-111) reflecting the general level of adaptation/social participation. As three items contribute to both the Adjustment and the Participation scales, the total score is less than the sum of the three subscales. Higher scores mean worse outcome.
Change from end of rehabilitation (T1) Mayo-Portland Adaptability Inventory-4 (MPAI-4) at 1-year post-rehabilitation (follow-up -T2)
Time frame: 1 year post-rehabilitation (post-rehabilitation to 1-year follow-up - T1-T2)
The MPAI-4 has 29 scored items and each item is scored on a 5-point scale (from 0 to 4). There are three subscales: Abilities (12 scored items, 0-47 after adjusting scores), Adjustment (9 scored items, 0-46 after adjusting scores), Participation (8 scored items, 0-30 after adjusting scores) giving specific indexes to each of these three dimensions, as well as a total score (all 29 items, 0-111) reflecting the general level of adaptation/social participation. As three items contribute to both the Adjustment and the Participation scales, the total score is less than the sum of the three subscales. Higher scores mean worse outcome.
Quality of Life after Brain Injury (QOLIBRI) status at 1-year post-rehabilitation
Time frame: 1-year post-rehabilitation (T2)
The MPAI-4 has 29 scored items and each item is scored on a 5-point scale (from 0 to 4). There are three subscales: Abilities (12 scored items, 0-47 after adjusting scores), Adjustment (9 scored items, 0-46 after adjusting scores), Participation (8 scored items, 0-30 after adjusting scores) giving specific indexes to each of these three dimensions, as well as a total score (all 29 items, 0-111) reflecting the general level of adaptation/social participation. As three items contribute to both the Adjustment and the Participation scales, the total score is less than the sum of the three subscales. Higher scores mean worse outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
Michelle McKerral, PhD principal investigator
CRIR-IURDPM-CCSMTL and Université de Montréal
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 Traumatic Brain Injury, run by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal 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 1 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: status not confirmed, as of the sponsor's last update on 28 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CRIR IURDPM-CCSMTL ((514) 340-2085 Ext. 4778, administration.crir@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from start of rehabilitation baseline (T0) Mayo-Portland Adaptability Inventory-4 (MPAI-4) at end of rehabilitation (post-intervention - T1) (time frame: Start to end of rehabilitation, an average of 1 year (pre-post rehabilitation - T0-T1)). The study lists 3 primary outcomes in all. 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 Aug 2024.