Clinical trial NCT04033952: Strategy Training on Improving Executive Functions in Persons Following Acquired Brain Injury
Official title: Strategy Training on Improving Executive Functions in Persons Following Acquired Brain Injury
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cognitive Impairment
Stroke
Acquired Brain Injury
Keywords: Stroke
Cognition
Rehabilitation
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: About two-third individuals with acquired brain injury (ABI) experience cognitive impairments. Deficits in executive functions is one of the most prevalent cognitive impairments following ABI which result in decline of recovery and independence. Lack of intervention shows evidence of immediate and long-term effect on executive function which is critical after returning to the community. The overall aim of this study is to examine the efficacy of strategy training intervention on executive functions and participation on community-dwelling people with ABI. Findings of the study will provide unequivocal evidence on the duration of effectiveness of strategy training and support the development and application of the program in rehabilitation practice.

Detailed description: The study will use a double-blinded, parallel-group randomized controlled trial to assess the efficacy of the strategy training intervention program in comparison to the control group. The investigators will recruit community-dwelling individuals with ABI in outpatient rehabilitation units and randomly assign them to the intervention group and the control group at a 1:1 ratio. Participants in the intervention group will receive strategy training 2 times per week for 10-15 sessions and participants in the control group will receive dose-matched non-active intervention carried out by a trained therapist. These efforts will allow the investigators to address the gap in rehabilitation research by demonstrating the effectiveness of strategy training on rebuilding and maintaining executive functions and lessening disability. This evidence will be important for rehabilitation practitioners to provide effective treatment to patients with cognitive impairments and will contribute to the improvement of quality of care of rehabilitation services.

Eligibility criteria: Inclusion Criteria:

* Ages 20 years and older
* Has a diagnosis of Acquired Brain Injury
* Understand Mandarin
* Has cognitive impairment
* Provide informed consent

Exclusion Criteria:

* Have severe aphasia
* Have a pre-stroke diagnosis of dementia, current major depressive disorder, substance use, or other psychiatric disorders that may impede them from continually participating in the study.

Primary outcomes:
measure: Stroop Test
timeFrame: Change from baseline to post-intervention within 1 week
measure: Trail-Making Test (TMT A and B)
timeFrame: Change from baseline to post-intervention within 1 week
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Change from baseline to post-intervention within 1 week
Secondary outcomes:
measure: Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms
timeFrame: Change from baseline to post-intervention within 1 week
measure: Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms
timeFrame: Change from post-intervention to 3 month follow-up, within 2 weeks
measure: Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms
timeFrame: Change from 3 month to 6 month follow-up, within 2 weeks
measure: Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms
timeFrame: Change from 6 month to 12 month follow-up, within 2 weeks
measure: Healing encounters and attitudes list positive outlook questionnaire short form (HEAL-PO)
timeFrame: Change from baseline to post-intervention within 1 week
measure: Healing encounters and attitudes list positive outlook questionnaire short form (HEAL-PO)
timeFrame: Change from post-intervention to 3 month follow-up, within 2 weeks
measure: Healing encounters and attitudes list positive outlook questionnaire short form (HEAL-PO)
timeFrame: Change from 3 month to 6 month follow-up, within 2 weeks
measure: Healing encounters and attitudes list positive outlook questionnaire short form (HEAL-PO)
timeFrame: Change from 6 month to 12 month follow-up, within 2 weeks
measure: General Self Efficacy Scale (GSCS)
timeFrame: Change from baseline to post-intervention within 1 week
measure: General Self Efficacy Scale (GSCS)
timeFrame: Change from post-intervention to 3 month follow-up, within 2 weeks
measure: General Self Efficacy Scale (GSCS)
timeFrame: Change from 3 month to 6 month follow-up, within 2 weeks
measure: General Self Efficacy Scale (GSCS)
timeFrame: Change from 6 month to 12 month follow-up, within 2 weeks
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Change from baseline to post-intervention within 1 week
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Change from post-intervention to 3 month follow-up, within 2 weeks
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Change from 3 month to 6 month follow-up, within 2 weeks
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Change from 6 month to 12 month follow-up, within 2 weeks
measure: Stroop Test
timeFrame: Change from post-intervention to 3 month follow-up, within 2 weeks
measure: Stroop Test
timeFrame: Change from 3 month to 6 month follow-up, within 2 weeks
measure: Stroop Test
timeFrame: Change from 6 month to 12 month follow-up, within 2 weeks
measure: Trail-Making Test (TMT A and B)
timeFrame: Change from post-intervention to 3 month follow-up, within 2 weeks
measure: Trail-Making Test (TMT A and B)
timeFrame: Change from 3 month to 6 month follow-up, within 2 weeks
measure: Trail-Making Test (TMT A and B)
timeFrame: Change from 6 month to 12 month follow-up, within 2 weeks
measure: National Institutes of Health Stroke scale (NIHSS)
timeFrame: Change from baseline to post-intervention within 1 week
measure: National Institutes of Health Stroke scale (NIHSS)
timeFrame: Change from post-intervention to 3 month follow-up, within 2 weeks
measure: National Institutes of Health Stroke scale (NIHSS)
timeFrame: Change from 3 month to 6 month follow-up, within 2 weeks
measure: National Institutes of Health Stroke scale (NIHSS)
timeFrame: Change from 6 month to 12 month follow-up, within 2 weeks
measure: Rancho Los Amigos Scale-Revised (RLAS-R)
timeFrame: Change from baseline to post-intervention within 1 week
measure: Rancho Los Amigos Scale-Revised (RLAS-R)
timeFrame: Change from post-intervention to 3 month follow-up, within 2 weeks
measure: Rancho Los Amigos Scale-Revised (RLAS-R)
timeFrame: Change from 3 month to 6 month follow-up, within 2 weeks
measure: Rancho Los Amigos Scale-Revised (RLAS-R)
timeFrame: Change from 6 month to 12 month follow-up, within 2 weeks
measure: Modified Rankin Scale (mRS)
timeFrame: Change from baseline to post-intervention within 1 week
measure: Modified Rankin Scale (mRS)
timeFrame: Change from post-intervention to 3 month follow-up, within 2 weeks
measure: Modified Rankin Scale (mRS)
timeFrame: Change from 3 month to 6 month follow-up, within 2 weeks
measure: Modified Rankin Scale (mRS)
timeFrame: Change from 6 month to 12 month follow-up, within 2 weeks
measure: Euro-QoL-5-Dimension (EQ-5D)
timeFrame: Change from baseline to post-intervention within 1 week
measure: Euro-QoL-5-Dimension (EQ-5D)
timeFrame: Change from post-intervention to 3 month follow-up, within 2 weeks
measure: Euro-QoL-5-Dimension (EQ-5D)
timeFrame: Change from 3 month to 6 month follow-up, within 2 weeks
measure: Euro-QoL-5-Dimension (EQ-5D)
timeFrame: Change from 6 month to 12 month follow-up, within 2 weeks
measure: Qualitative data
timeFrame: After intervention, an average of 2 month
measure: Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
timeFrame: Change from baseline to post-intervention within 1 week
measure: Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
timeFrame: Change from post-intervention to 3 month follow-up, within 2 weeks
measure: Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
timeFrame: Change from 3 month to 6 month follow-up, within 2 weeks
measure: Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
timeFrame: Change from 6 month to 12 month follow-up, within 2 weeks
measure: Resting-state functional Magnetic Resonance Imaging scan (rs-fMRI)
timeFrame: Change from baseline to post-intervention within 1 week
measure: Resting-state functional Magnetic Resonance Imaging scan (rs-fMRI)
timeFrame: Change from post-intervention to 1 year follow-up, within 2 weeks
measure: functional Magnetic Resonance Imaging scan with a Color Stroop task
timeFrame: Change from baseline to immediately post-intervention within 1 week
measure: functional Magnetic Resonance Imaging scan with a Color Stroop task
timeFrame: Change from post-intervention to 1 year follow-up, within 2 weeks
measure: functional Magnetic Resonance Imaging scan of anatomical structure
timeFrame: Change from baseline to post-intervention within 1 week
measure: functional Magnetic Resonance Imaging scan of anatomical structure
timeFrame: Change from post-intervention to 1 year follow-up, within 2 weeks
measure: functional Magnetic Resonance Imaging scan with a Emotion Stroop task
timeFrame: Change from baseline to post-intervention within 1 week
measure: functional Magnetic Resonance Imaging scan with a Emotion Stroop task
timeFrame: Change from post-intervention to 1 year follow-up, within 2 weeks
measure: Healing encounters and attitudes list patient-provider connection short form (HEAL-PPC)
timeFrame: At the time of post-intervention within 1 week
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Change from post-intervention to 3 month follow-up, within 2 weeks
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Change from 3 month to 6 month follow-up, within 2 weeks
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Change from 6 month to 12 month follow-up, within 2 weeks
measure: Pittsburgh Rehabilitation Participation Scale
timeFrame: During the procedure
measure: Level of understanding of the intervention session
timeFrame: During the procedure
measure: Healing encounters and attitudes list treatment expectancy short form (HEAL-TE)
timeFrame: baseline, pre-intervention
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: At the time of post-intervention within 1 week
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital Bei-Hu branch
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
affiliation: Taipei Medical University
name: Feng-Hang Chang
role: PRINCIPAL_INVESTIGATOR
References: