Do Combinatorial Training Lead to Better Cognition and Daily Participation in TBI Persons With Cognitive Impairments
NCT04051528, Not applicable, Unknown, Chang Gung Memorial Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Do Combinatorial Training Lead to Better Cognition and Daily Participation in TBI Persons With Cognitive Impairments | ClinicalTrials.gov |
| NCT number | NCT04051528 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 50 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Chang Gung Memorial Hospital | ClinicalTrials.gov |
| Conditions | Trauma, Brain, Cognitive Deficit | ClinicalTrials.gov |
| Interventions | aerobic exercise training, computerized cognitive training, guiding training | ClinicalTrials.gov |
| First posted | 2019-08-09 | ClinicalTrials.gov |
| Last updated | 2021-06-21 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change scores of Montreal Cognitive Assessment (MoCA) | Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions) | The Montreal Cognitive Assessment (MoCA) will be used to assess general cognitive functions. It examines several cognitive domains with a total score of 30 and higher values indicate better cognitive functions. The MoCA has been shown to be a valid and promising tool to evaluate the global cognitive function in patients with stroke. The psychometric properties of MoCA are good to excellent for patients with cerebrovascular diseases. | ClinicalTrials.gov |
| Primary | Change scores of Wechsler Memory Scale - Third Edition (WMS-III) | Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions) | Several subtests of Wechsler Memory Scale - Third Edition (WMS-III) including Faces Recognition (total scale=48), Verbal Paired Associates (total scale = 32), Word Lists (total scale = 48), and Spatial Span (total scale=32) will be used to assess the immediate, delayed, and working memory tests. For each subtest, a higher number indicates better performance in memory function. The raw score of subtests will also be transferred to standardized Z scores and summed to represent an index of general memory function. | ClinicalTrials.gov |
| Primary | Change scores of Stroop Color-Word test | Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions) | The Stroop Color-Word test assesses the abilities of selective attention, inhibition and executive function. The participants will be tested under congruent and incongruent conditions. In the congruent condition, the participant will name the color ink of a word which is consistent with the written color name; whereas in the incongruent condition the participant will name the color ink differs from the written color name. In both conditions, the number of colors correctly named within 45 seconds will be measured and the performance in the congruent condition will be compared with the incongruent condition (Quaney et al., 2009). | ClinicalTrials.gov |
| Primary | Change scores of Trail Making Test (TMT) | Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions) | The TMT is a neuropsychological test of visual attention and task switching. It consists of two parts (TMT-A and TMT- B) in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The Chinese version of the TMT has been suggested to be a reliable instrument for measuring executive function among older adults. The scores for both TMT A and B are reported as the number of seconds required to complete the task. According to the TMT directions for administration, an average score for the TMT Part A is 29 seconds and a deficient score is greater than 78 seconds. For the TMT Part B, an average score is 75 seconds and a deficient score is greater than 273 seconds. Therefore, higher scores reveal greater impairment. | ClinicalTrials.gov |
| Primary | Change scores of Six-minutes Walking Test (6MWT) | Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions) | The 6MWT measures the maximum distance walked over 6 minutes, which assess the endurance and mobility level of the participants. The participants could rest as needed during the course of the test. The test-retest reliability and responsiveness has been established to be high for patients with chronic stroke (Fulk, Echternach, Nof, \& O'Sullivan, 2008). | ClinicalTrials.gov |
| Primary | Change scores of 30-second Chair-Stand Test (30CST) | Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions) | The 30 second chair stand test (CST) will be assessed to indicate the strength and endurance level of the lower extremities. The participants will be asked to stand up from a standardized chair and then sit down as many times as possible within 30 seconds. The feasibility and reliability of using CST in people with cognitive impairment have been established to be good (Blankevoort et al., 2013). | ClinicalTrials.gov |
| Primary | Change scores of Berg Balance Scale (BBS) | Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions) | The Berg balance scale is a test of a person's static and dynamic balance abilities. This scale comprises a set of 14 simple balance related tasks, ranging from standing up from a sitting position, to standing on one foot. The degree of success in completing each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all scores. The range of score is 0-56 and a below average score indicates a high risk for falls. Excellent test-retest reliability has been reported in acquired brain injury. | ClinicalTrials.gov |
| Primary | Change scores of Lower extremity muscle strength. | Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions) | We will evaluate isometric knee flexors and extensors muscle strength using handheld dynamometer. The participant will be seated upright in a chair with back support, the knee will be placed in 90-degree flexion and the evaluator will stabilize the thing to eliminate synergistic movements. Participants will be asked to perform a maximal isometric contraction of knee flexion and extension with affected and less affected side. We will record the mean value of 3 attempts. | ClinicalTrials.gov |
| Primary | Change scores of Mobility Level | Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions) | An objective measure of the amount of arm movements in real-life situations will be provided by the accelerometers. Actigraphy activity monitors (ActiGraph, Shalimar, FL, USA) will be worn on participants' wrists for 3 consecutive days before and after training to measure the number of moves each minute, and the average counts of move per minute. The participants will be asked to wear the device during the day and data recorded by the actigraphy will be analyzed with the MAHUFFE software (http://www.mrc-epid.cam.ac.uk/). The use of actigraphy has been validated for patients with TBI. | ClinicalTrials.gov |
| Primary | Change scores of Timed Up and Go test (TUG) | Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions) | The TUG assesses the dynamic balance ability and mobility. The participants will be required to stand up from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. The test-retest reliability of TUG on individuals with stroke was excellent (Ng \& Hui-Chan, 2005). | ClinicalTrials.gov |
| Primary | Change scores of Functional Independence Measure (FIM) | Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions) | The FIM assesses the dependence level of individuals with stroke to perform 18 activities (13 motor and five cognitive tasks) in daily living. The score ranges from 18 to 126 and higher scores demonstrate greater independent participation in daily activities (Ottenbacher, Hsu, Granger, \& Fiedler, 1996). The FIM has good interrater reliability and validity (Hsueh, Lin, Jeng, \& Hsieh, 2002). | ClinicalTrials.gov |
| Primary | Change scores of Activity Outcome Measurement for Post-Acute Care (AM-PAC) | Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions) | The AM-PAC assess difficulties in daily participation with 58 items containing the following aspects: physical functioning, self-care, daily routine, communication, and interpersonal interaction. The items and scoring system are adopted from the ICF framework. The AM-PAC has adequate reliability and validity. There are three specific functional domains: basic mobility(score range=18-72), daily activity(score range=15-60) and applied cognitive(score range=19-76). For each subtest, a higher score indicates better performance. | ClinicalTrials.gov |
| Primary | Change scores of Participation Measure-3 Domains, 4 Dimensions (PM-3D4D) | Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions) | The PM-3D4D includes 24 items measuring participation in productivity(6 items), social(12 items), and community(6 items) domains across 4 dimensions: diversity of participation(Y/N), frequency of participation(0-6), desire for change(Y/N), and difficulty in participation(1-4). The score of diversity of participation is percent of the number of items in which a person answered yes divided by the total number of items within each domain. The score of frequency of participation is sum of the ratings divided by the total number of items within each domain. The score of desire for change is percent of the number of items in which a person answered yes divided by the total number of items within each domain. The score of difficulty in participation is total score within each domain. The PM-3D4D has been shown adequate reliability and validity in rehabilitation patients. | ClinicalTrials.gov |
| Primary | Change scores of Goal Attainment Scaling (GAS) | Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions) | The GAS assesses the extent to which patient's individual goals are achieved in the course of intervention. The GAS has been shown responsive to the change in cognitive rehabilitation. It used to quantify the extent to which treatment goals were achieved. Individual goals were evaluated in a standardized way, using predefined levels of achievement based on current and expected performance. A 5-point Goal Attainment Scale was used: the baseline level (-2), partial achievement (-1), the expected level of achievement (0), small better than expected levels (1), remarkably better than expected levels(2). | ClinicalTrials.gov |
| Primary | Change scores of Beck depression inventory-version II (BDI-II) | Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions) | The Beck depression inventory is a self-report measure of depression severity. Excellent reliability and validity have been established in patients with TBI. The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. The range of score is 0-63 and higher total scores indicate more severe depression. | 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 |
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Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
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 5
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 |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Task Switching Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Word Pair Learning | 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)