Functional Evolution of Traumatic Brain Injured Adults During Rehabilitation and Social Participation

NCT05022940 | Recruiting DMC

• 1 other identifier: CRIR MMcK 2
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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

Keywords

Social participation; Quality of life

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  1-year post-rehabilitation (T2)

Study Arms (1)

TBI rehabilitation

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

Other: Usual gold-standard multidisciplinary rehabilitation for TBI

Interventions

Usual gold-standard multidisciplinary rehabilitation for TBI OTHER

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.

TBI rehabilitation

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with a mild, moderate or severe TBI who are referred and registered in a multidisciplinary holistic rehabilitation program.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal: lead
• Fonds de la Recherche en Santé du Québec: collaborator

Study Sites (1)

CRIR

Montreal, Quebec, H3S1M9, Canada

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Whole-Body Irradiation

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Investigative Techniques

Study Officials

• Michelle McKerral, PhD

  CRIR-IURDPM-CCSMTL and Université de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CRIR IURDPM-CCSMTL

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Researcher

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 26, 2021
• Study Start: June 1, 2017
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

CA (1)