Acute Neurobehavioral Program for Improving Functional Status After TBI
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|ClinicalTrials.gov Identifier: NCT01166386|
Recruitment Status : Completed
First Posted : July 21, 2010
Results First Posted : October 5, 2021
Last Update Posted : April 22, 2022
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Behavioral: FANCI||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||165 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||An Acute Neurobehavioral Program for Improving Functional Status After TBI|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
Experimental: First steps treatment intervention
A brief 10-session manualized acute neurobehavioral intervention program will be individually implemented with randomly assigned treatment participants. Session components include injury-related education, enhancement of self-awareness of deficits from the TBI, coping and cognitive skills training, and supported practice. The acronym "FANCI" refers to the name of the program which is First Steps Acute Neurobehavioral and Cognitive Intervention.
comprehensive neurobehavioral sessions with therapist administrating treatment components
Other Name: First Steps Acute Neurobehavioral and Cognitive Intervention
Placebo Comparator: standard rehabilitation care
The controls will spend 10 one-half hours with a therapist viewing videos they choose from a menu, some of which have to do with brain injury. The therapist will interact naturally with the controls and occasionally relate the movie or film to brain injury rehabilitation.
Watching DVDs chosen by participants on various topics.
Other Name: control condition
- Functional Independence Measure Scores [ Time Frame: Pre, at end of treatment up to one week, six-month follow up ]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
- Neurobehavioral Rating Scale [ Time Frame: Pre, post, six month follow up ]The Neurobehavioral Rating Scale (NRS) is a provider or family rating scale for describing cognition, emotional, behavioral characteristics of a patient with brain injury. Twenty-seven items assess symptoms such as Fatigueability, Depressive Mood, and Tension with 7-point rating scale including "not present," "Very mild," "Mild," "Moderate," "Mod-Severe," "Severe," and "Extremely Severe" to describe the person being rated. Higher scores indicate worse severity of symptoms and lower score indicate an absence of the symptom or very mild symptomatology. The minimum total score is 27 and the maximum total score is 189. For each individual scale within the measures, the minimum score is 1 and the maximum score is 7.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01166386
|United States, North Carolina|
|Carolinas Rehabilitation, Carolinas Medical Center, Department of Physical Medicine and Rehabilitation|
|Charlotte, North Carolina, United States, 28203|
|Principal Investigator:||Janet P Niemeier, Ph.D.||Carolinas Rehabilitation, Carolinas Healthcare System|