Recruiting

Observational Study

Sponsor:

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Code:

NCT05022940

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 17+

Healthy Volunteers: Not accepted

Interventions

Usual gold-standard multidisciplinary rehabilitation for TBI

Study Details

Brief 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, 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.

Conditions

Traumatic Brain Injury

Study ID

NCT05022940

Start date

Jun 1, 2017

Status verified date

Aug, 2024

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Jun 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 17+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All adult TBI patients receiving post-acute rehabilitation services.

Exclusion Criteria:

  • TBI patients that do not complete at least one month of rehabilitation.

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Arms

TBI rehabilitation

All individuals with mild, moderate or severe TBI registered into rehabilitation.

Interventions

Usual gold-standard multidisciplinary rehabilitation for TBI

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.

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) ]
  • 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) ]
  • Quality of Life after Brain Injury (QOLIBRI) status at 1-year post-rehabilitation [ Time Frame: 1-year post-rehabilitation (T2) ]

Central Contacts and Locations

Central contacts

CRIR IURDPM-CCSMTL

(514) 340-2085 Ext. 4778administration.crir@ssss.gouv.qc.ca

Locations

CRIR

Recruiting

Montreal, Quebec, Canada, H3S1M9

Contacts

Michelle McKerral

5148678170michelle.mckerral@umontreal.ca

More Information

Sponsor

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Last update posted

Aug 28, 2024

Last verified

Aug, 2024

Keywords

  • Social participation
  • Quality of life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal on 2024-08-28.