About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All adult TBI patients receiving post-acute rehabilitation services.
Disqualifiers
TBI patients that do not complete at least one month of rehabilitation.
Trial population
Individuals with a mild, moderate or severe TBI who are referred and registered in a multidisciplinary holistic rehabilitation program.
Trial design
Cohort
Prospective
Treatments tested in this trial
Usual gold-standard multidisciplinary rehabilitation for TBI
Other interventionIn 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Sponsors and contacts
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Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Lead sponsor
Fonds de la Recherche en Santé du Québec
Collaborator