Strategy + RehaCom for Memory Rehabilitation in Traumatic Brain Injury (TBI)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2022-11-28

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Traumatic Brain Injury With Loss of Consciousness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a double-blind randomized clinical trial. Participants will be randomly assigned to a treatment group or wait-list control group.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Group assignments will be concealed and assessments and interventions will be conducted by trained staff blinded to each other's findings and data.

Study Groups

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Group A

Receive intervention 2 weeks after group assignment.

Group Type EXPERIMENTAL

RehaCom (software)

Intervention Type 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).

Group B

Wait List - Receive intervention 3 months after initial testing.

Group Type OTHER

RehaCom (software)

Intervention Type 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).

Interventions

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RehaCom (software)

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).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Able to read and speak English fluently at the 5th grade level (for testing; software has multilingual support)
* Had a TBI at least 1 year ago
* No history of learning disorders during school years
* Able to use a personal computer (PC) non-stop for 1 hour without health or visual complaints; able to press keyboard buttons.No history of learning disorders