Trial · NCT04017091
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | VR Stroop: Change in response times from session1 to session 8 for correct and incongruent trials | 2 times a week for 4 weeks. VR Stroop is administered during all sessions: sessions 1-8 | The VR Stroop was administered at each of the 8 study sessions, through study completion. In both the Inhibition and the Interference Trial, the metric being measured was how quickly patient responds to a target on matching (visual color matches aurally presented color) and non-matching trials (visual color does not match aurally presented color). Metric is measured in milliseconds. |
| Primary | VR Stroop: Change in number of total commission errors | 2 times a week for 4 weeks. VR Stroop is administered during all sessions: sessions 1-8 | The VR Stroop was administered at each of the 8 study sessions, through study completion. In both the Inhibition and the Interference Trial, the metric being measured was # of impulsive responses (raw score). |
| Primary | VR Stroop: Change in number of total omission errors | 2 times a week for 4 weeks. VR Stroop is administered during all sessions: sessions 1-8 | The VR Stroop was administered at each of the 8 study sessions, through study completion. In both the Inhibition and the Interference Trial, the metric being measured was # of attentional errors (missed items raw score). |
| Secondary | Wechsler Test of Adult Reading (WTAR) | After week 4 of study - which was typically week 5-7 of the neurorehabilitation course (Administration of traditional neuropsychological measures followed study completion to avoid confounds & practice effects). Single time point. | The WTAR is a single-word reading or word pronunciation measure. It also provides an estimate of premorbid intellectual functioning. The metric of interest for the WTAR was the total score (standard score). In statistics, the standard score is the signed number of standard deviations an observation or datum is above the mean. The mean standard score for the WTAR is 100, with scores above the mean being positive, and scores below the mean being negative. This data was archival for Controls. |
| Secondary | Trail Making Tests (TMT) | After week 4 of study - which was typically week 5-7 of the neurorehabilitation course (Administration of traditional neuropsychological measures followed study completion to avoid confounds & practice effects). Single time point. | TMT measures visuomotor processing speed, visual attention, and set-shifting. The raw score was time to completion in seconds, with lower values indicating stronger performance and higher values indicating weaker performance. This raw score was converted to a T-score. We also analyzed number of raw errors (reversals and set-shifting). This data was archival for Controls. |
| Secondary | Verbal Fluency Tests (COWAT and Animals) | After week 4 of study - which was typically week 5-7 of the neurorehabilitation course (Administration of traditional neuropsychological measures followed study completion to avoid confounds & practice effects). Single time point. | COWAT assess phonemic fluency. Animals assessed category fluency. The raw score consists of total number correct across 3 trials for COWAT and a single trial for Animals. The raw score is converted to a T-score. This data was archival for Controls. |
| Secondary | Stroop Color and Word Test, Golden version | After week 4 of study - which was typically week 5-7 of the neurorehabilitation course (Administration of traditional neuropsychological measures followed study completion to avoid confounds & practice effects). Single time point. | The Golden version Stroop consists of 3 trials: word reading, color naming, and inhibition. The raw score consists of the number of words or colors correctly read within 45 seconds. Lower values indicate stronger performance and higher values indicate weaker performance. The raw score for each trial is converted to a T-score. This data was archival for Controls. |
| Secondary | Functional Assessment of Verbal Reasoning and Executive Strategies (FAVRES) | Week 1 of study and after week 4 of study. | Performance on the Make a Decision subtest: Accuracy Raw and Analysis of Reasoning Raw scores. Accuracy of the solution to each sub-test is scored on a scale from 0 (no viable solution) to 5 (best possible solution). Reasoning (rationale) is based on # of valid reasons included in response, with raw score equaling the # of viable options. This data was archival for Controls. |
| Secondary | Ross Information Processing Assessment (RIPA), 2nd Edition | Week 1 of study and after week 4 of study. | Problem-Solving subtest raw score: Patient is required to respond to 10 stimuli requiring problem-solving and reasoning strategies for task completion. Organization subtest raw score: Patient is required to recall category members within a 1-minute time limit and to recall a category type given three category members. More response options generated indicates stronger performance for both subtests, with a raw score out of a maximum of 30 (X/30). This data was archival for Controls. |
| Secondary | Holistic Outcome Measure (HOM): Change in level of independence | HOM home, community, and community participation scores at discharge compared with those at admission. | The HOM assess level of independence in (1) the home, (2) the community, and (3) community participation, rated 1-5 by clinicians. A score of 1 indicates a need for full-time supervision and participation is limited to medical appointments, and 5 indicates full independence. Each category is considered independently. This data was archival for Controls. |
| Secondary | Mayo-Portland Adaptability Inventory, 4th Edition (MPAI-4): Change in level of independence | MPAI-4 abilities, adjustment, and participation scores at discharge compared with those at admission. | MPAI-4 consists of 3 subscales: Abilities, Adjustment, Participation, which assess sensory, cognitive, and motor abilities; emotional and neurological symptoms, interpersonal adjustment, and awareness; \& social, work, and leisure participation and management of IADLs respectively. They are rated 0-4 by clinician (0 = No problem, does not interfere with activities; does not use assistive device or medication; 4 = Severe problem; interferes with activities more than 75% of the time). Each subscale is summed to produce a score, and all 3 subscores are combined to produce a total score. This data was archival for Controls. |
| Other | Simulator Sickness Questionnaire (SSQ) | 6 time intervals over 4 weeks (1x in week 1, 2x in week 2, 2x in week 3, 1x in week 4). During VR sessions 2-7. | The SSQ assesses occurrence, nature and severity of sickness symptoms induced by VR environment, rated 0-3 by patient. A score of indicates =no symptom; 1=slight; 2=moderate; 3=severe symptoms. As such, lower scores indicate that a patient is less affected by the use of VR devices. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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