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| Name | Class |
|---|---|
| New Jersey Medical School | OTHER |
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The purpose of this research study is to evaluate the effectiveness of "RehaCom," a computerized treatment for memory deficits, in a 16-session, interactive course. Following a manualized approach, the Rehacom modules will be used for the repeated application of the content acquired during 1-on-1 memory strategy training. The goal is to improve face/name, list and verbal memory of patients who survived a moderate to severe traumatic brain injury.
This randomized clinical trial (RCT) consists of 20 chronic moderate-to-severe TBI patients who will receive memory strategy training and complete three memory modules of the RehaCom at one of the Kessler Foundation locations. Changes in attention, processing speed, verbal/non-verbal new learning and memory (NLM) and executive control will be assessed via pre/post and 3-month follow-up assessments before and after the 8-10 week intervention. Self-report questionnaires will also track functional and emotional outcomes such as mood and anxiety, cognition, quality of life, self-efficacy, deficit awareness, community participation, and readiness for occupational functioning
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Receive intervention 2 weeks after group assignment. |
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| Group B | Other | Wait List - Receive intervention 3 months after initial testing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RehaCom (software) | Device | RehaCom software has gamified, interactive modules that will help participants practice the application of various memory strategies at custom, increasingly more difficult levels. Instructor will also use the software to teach and demonstrate the use of memory strategies with the domains targeted (i.e., list learning, remembering written/verbal information, and memory for names/faces). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in California Verbal Learning Test - II (CVLT-II) performance | We will use the raw scores for free and cued delayed recall [0-16] where higher scores indicate better verbal recall. | Baseline & 10-14 weeks after baseline assessment |
| Change in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) - Story Memory performance | Raw scores from Story A and Story B recall [0-50], where higher scores indicate better recall. | baseline & 10-14 weeks after baseline assessment |
| Change in Wechsler Memory Scale III - Faces II performance | Delayed Recall Score [0-48] where higher scores indicate better recall. | baseline & 10-14 weeks after baseline assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kessler Foundation | East Hanover | New Jersey | 07936 | United States |
Data will not be available at the individual level except for parties identified by the New Jersey Health Foundation (funding agency) and approved/mandated by the Kessler Foundation Institutional Review Board (IRB).
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This study is a double-blind randomized clinical trial. Participants will be randomly assigned to a treatment group or wait-list control group.
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Group assignments will be concealed and assessments and interventions will be conducted by trained staff blinded to each other's findings and data.
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