Effectiveness of Multimodal Cognitive Rehabilitation for Traumatic Brain Injury Sustained During Older Adulthood
NCT04590911, Not applicable, Completed, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effectiveness of Multimodal Cognitive Rehabilitation for Traumatic Brain Injury Sustained During Older Adulthood | ClinicalTrials.gov |
| NCT number | NCT04590911 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 42 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal | ClinicalTrials.gov |
| Conditions | TBI (Traumatic Brain Injury), Rehabilitation, Aging | ClinicalTrials.gov |
| Interventions | Cognitive Enrichment Program (CEP) | ClinicalTrials.gov |
| First posted | 2020-10-19 | ClinicalTrials.gov |
| Last updated | 2024-08-28 | ClinicalTrials.gov |
Registered outcomes 18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change from baseline (T0) Face-name association (Côte-des-Neiges Computerized Memory Battery) at 14 weeks (post-intervention - T1) | 14 weeks (pre-post intervention - T0-T1) | Episodic memory measure where participants have to associate 12 previously learned face-name pairs. | ClinicalTrials.gov |
| Primary | Change from post-intervention (T1) Face-name association (Côte-des-Neiges Computerized Memory Battery) at 6 months post-intervention (follow-up - T2) | 6-months post-intervention (follow-up - T2) | Episodic memory measure where participants have to associate 12 previously learned face-name pairs. | ClinicalTrials.gov |
| Primary | Change from baseline (T0) Word list recall (Côte-des-Neiges Computerized Memory Battery) at 14 weeks (post-intervention - T1) | 14 weeks (pre-post intervention - T0-T1) | Episodic memory measure where participants have to associate 12 previously learned words. Measures of immediate and delayed recall were obtained. | ClinicalTrials.gov |
| Primary | Change from post-intervention (T1) Word list recall (Côte-des-Neiges Computerized Memory Battery) at 6-months post-intervention (follow-up - T2) | 6-months post-intervention (follow-up - T2) | Episodic memory measure where participants have to associate 12 previously learned words. Measures of immediate and delayed recall were obtained. | ClinicalTrials.gov |
| Primary | Change from baseline (T0) Text memory (Côte-des-Neiges Computerized Memory Battery) at 14 weeks (post-intervention - T1) | 14 weeks (pre-post intervention - T0-T1) | Episodic memory measure where participants have to recall a short text, which is divided into 23 macrostructure elements (main ideas of the text giving a meaning to the story), and 24 microstructure elements (specific details about the story). Measures of immediate and delayed recall were obtained for macrostructure and microstructure elements. | ClinicalTrials.gov |
| Primary | Change from post-intervention (T1) Text memory (Côte-des-Neiges Computerized Memory Battery) at 6-months post-intervention (follow-up - T2) | 6-months post-intervention (follow-up - T2) | Episodic memory measure where participants have to recall a short text, which is divided into 23 macrostructure elements (main ideas of the text giving a meaning to the story), and 24 microstructure elements (specific details about the story). Measures of immediate and delayed recall were obtained for macrostructure and microstructure elements. | ClinicalTrials.gov |
| Primary | Change from baseline (T0) Self-Evaluation Memory Questionnaire (SEMQ) at 14 weeks (post-intervention - T1) | 14 weeks (pre-post intervention - T0-T1) | Self-report memory measure where participants rate (1 to 6; never to always) their memory performance for 10 dimensions for which are derived mean scores: Conversations, Books \& movies, Slips of attention, People, Use of objects, Political \& social events, Places, Actions to perform, Personal events, General. Higher scores indicate worse outcome. | ClinicalTrials.gov |
| Primary | Change from post-intervention (T1) Self-Evaluation Memory Questionnaire (SEMQ) at 6-months post-intervention (follow-up - T2) | 6-months post-intervention (follow-up - T2) | Self-report memory measure where participants rate (1 to 6; never to always) their memory performance for 10 dimensions for which are derived mean scores: Conversations, Books \& movies, Slips of attention, People, Use of objects, Political \& social events, Places, Actions to perform, Personal events, General. Higher scores indicate worse outcome. | ClinicalTrials.gov |
| Primary | Change from baseline (T0) Six Elements Task-Adapted (SET-A) at 14 weeks (post-intervention - T1) | 14 weeks (pre-post intervention - T0-T1) | Executive function measure where participants complete a task where the goal is to earn as many points as possible while following specific rules. Five dimensions are rated according to the degree of attainment (0-3) : Tackling the 6 subtasks, Inter-task balance, Avoiding rule-breaking, Checking time at appropriate moments, and Efficient behavior. The Total score (/15) is also computed. | ClinicalTrials.gov |
| Primary | Change from post-intervention (T1) Six Elements Task-Adapted (SET-A) at 6-months post-intervention (follow-up - T2) | 6-months post-intervention (follow-up - T2) | Executive function measure where participants complete a task where the goal is to earn as many points as possible while following specific rules. Five dimensions are rated according to the degree of attainment (0-3) : Tackling the 6 subtasks, Inter-task balance, Avoiding rule-breaking, Checking time at appropriate moments, and Efficient behavior. The Total score (/15) is also computed. | ClinicalTrials.gov |
| Primary | Change from baseline (T0) Sorting Test - Delis-Kaplan Executive Function System (D-KEFS) at 14 weeks (post-intervention - T1) | 14 weeks (pre-post intervention - T0-T1) | Executive function measure where participant must sort cards with printed words into groups in as many ways as possible and describe their sorting criteria. Measures used are: Confirmed Correct Sort Total (CCS) raw score, Free Sorting Description (FSD) total raw score, and Time-Per-Sort Ratio (TSR) in seconds. | ClinicalTrials.gov |
| Primary | Change from post-intervention (T1) Sorting Test - Delis-Kaplan Executive Function System (D-KEFS) at 6-months post-intervention (follow-up - T2) | 6-months post-intervention (follow-up - T2) | Executive function measure where participant must sort cards with printed words into groups in as many ways as possible and describe their sorting criteria. Measures used are: Confirmed Correct Sort Total (CCS) raw score, Free Sorting Description (FSD) total raw score, and Time-Per-Sort Ratio (TSR) in seconds. | ClinicalTrials.gov |
| Primary | Change from baseline (T0) Stroop Test - Four-color version at 14 weeks (post-intervention - T1) | 14 weeks (pre-post intervention - T0-T1) | Executive function measure where participant complete four tasks (reading, colors, inhibition and flexibility). The measures used (time, in seconds) are Inhibition of the Stroop effect by verbally indicating the color of the ink instead of reading the words, and Flexibility, where participants indicate the color of the ink and read the words when they appear in a box. | ClinicalTrials.gov |
| Primary | Change from post-intervention (T1) Stroop Test - Four-color version at 6-months post-intervention (follow-up - T2) | 6-months post-intervention (follow-up - T2) | Executive function measure where participant complete four tasks (reading, colors, inhibition and flexibility). The measures used (time, in seconds) are Inhibition of the Stroop effect by verbally indicating the color of the ink instead of reading the words, and Flexibility, where participants indicate the color of the ink and read the words when they appear in a box. | ClinicalTrials.gov |
| Primary | Change from baseline (T0) Dysexecutive Questionnaire (DEX) at 14 weeks (post-intervention - T1) | 14 weeks (pre-post intervention - T0-T1) | Self-report executive function measure where participants rate (0 to 5; never to always) their executive functioning on three scales: Executive cognition, Behavioural-Emotional Self-Regulation, and Metacognition. Self-awareness of executive difficulties was used as a measure of generalization by calculating the difference between participants' and a significant other's scores on the three subscales. Higher scores indicate worse outcome. | ClinicalTrials.gov |
| Primary | Change from post-intervention (T1) Dysexecutive Questionnaire (DEX) at 6-months post-intervention (follow-up - T2) | 6-months post-intervention (follow-up - T2) | Self-report executive function measure where participants rate (0 to 5; never to always) their executive functioning on three scales: Executive cognition, Behavioural-Emotional Self-Regulation, and Metacognition. Self-awareness of executive difficulties was used as a measure of generalization by calculating the difference between participants' and a significant other's scores on the three subscales. Higher scores indicate worse outcome. | ClinicalTrials.gov |
| Primary | Change from baseline (T0) Psychological General Well-Being Index (PGWBI) at 14 weeks (post-intervention - T1) | 14 weeks (pre-post intervention - T0-T1) | Self-report measure where participants rate (0-6; low to high) their self-perceived well-being on 22 items. Higher scores indicate better outcome. | ClinicalTrials.gov |
| Primary | Change from post-intervention (T1) Psychological General Well-Being Index (PGWBI) at 6-months post-intervention (follow-up - T2) | 6-months post-intervention (follow-up - T2) | Self-report measure where participants rate (0-6; low to high) their self-perceived well-being on 22 items. Higher scores indicate better outcome. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 2
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Face-name Memory Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)