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NCT01166386 · ClinicalTrials.gov registry record · NA
Acute Neurobehavioral Program for Improving Functional Status After TBI
A NA study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- NA
- Development phase
- 165
- Enrollment target
NCT01166386: Completed NA study, sponsored by Wake Forest University Health Sciences.
NCT01166386 is a NA study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 165 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01166386, a NA study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 165 participants
- Enrollment target
Study 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.
Primary Outcome
Minimum score = 18 Maximum possible with FIM = 126 directionality is toward the level of independence, lower numbers signify greater dependence on help from another person to complete the task or activity
Interventions
- BEHAVIORAL FANCI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2008-03 |
| Est. Completion | 2014-01 |
| Phase | NA |
What the finished NCT01166386 record still lists
NCT01166386 is an interventional study that assigns participants to a tested intervention. The registered 165 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which FANCI is the first listed.
NCT01166386 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01166386 about?
NCT01166386 is a clinical study titled "Acute Neurobehavioral Program for Improving Functional Status After TBI". 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 m...
What is the current status of trial NCT01166386?
This trial is currently completed. It is a NA study. The enrollment target is 165 participants. The study started on 2008-03. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01166386?
The interventions under investigation include: FANCI (BEHAVIORAL).
Who is sponsoring clinical trial NCT01166386?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01166386's enrollment target sits among peer trials
165 626th of 2000 higher than 1,375 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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