CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 165 enrolled
Drug / intervention
FANCI +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01166386
NCT01166386N/ACompleted

An Acute Neurobehavioral Program for Improving Functional Status After TBI

Wake Forest University Health Sciences·interventional·Posted Jul 21, 2010·Updated Apr 22, 2022

In Brief

A clinical study evaluating FANCI for Traumatic Brain Injury. Completed, enrolled 165 participants across 1 site.

Detailed Summary

The specific aims of the proposed study are to 1) evaluate the efficacy of FANCI for improving functional status following treatment using the FIM, 2) examine the impact of FANCI on broader outcome measures of general emotional and behavioral functioning and productive activity in the community as measured post-treatment and at 6-month follow-up, 3) examine contributions of participant injury severity and cognitive status at time of treatment to treatment outcome and treatment response, 4) examine contributions of treatment variables of session topic and mastery, caregiver presence, and concurrent therapies on treatment outcome and treatment response for inpatients with TBI. Primary outcome measure is the (FIM). We will secondarily compare scores on the Disability Rating Scale (DRS), Glasgow Outcome Scale-Extended (GOSE), Rehabilitation Intensity of Therapy Scale (RITS), and Frontal Systems Behavior Scale (FRsBe). Our design is a parallel groups, single-blind, randomized, controlled trial. We will enroll 150 (75 treatment, 75 control) participants. Inclusion Criteria: Mod to Sev TBI based on time to commands, English speaker, Length of stay ≥ 5 days in acute BI rehabilitation Unit, 18 years of age or older, ≥ 79 on GOAT.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 21, 2010
Enrollment StartMar 1, 2008
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 15.9 years ago

Interventions

FANCIbehavioral

comprehensive neurobehavioral sessions with therapist administrating treatment components

FANCIbehavioral

Watching DVDs chosen by participants on various topics.