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Treatment Optimization of Brain-injured Warfighters

Study acronym: (TOBI-SET)
StatusUnknown
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 19, 2024 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Aug 2024); last known: Recruiting
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Prescribed sub-symptomatic adaptable exercise treatment (SAET) is a potential solution that promotes recovery needs following a TBI. SAET has been shown to benefit the mind and body in ways that decrease the severity and frequency of mild TBI (mTBI) symptoms. This study aims to validate SAET as an alternative, adaptable treatment or SMs with mTBI that focuses on reducing symptoms, improving mental health, increasing physiological functioning, and ultimately returning to duty. The objective of this study is to develop a prescribed exercise treatment program for warfighters with mTBI that can be personalized for SM's needs (i.e., medical and occupational) and is adaptable to various clinical resources (e.g., forward operating bases, rural clinics, and mTBI specialty programs). The key question raised by this study is whether SAET is more effective than a stretching control group (SCG) in reducing neurobehavioral symptoms among SMs with persistent complaints following a mTBI.
Trial Details
NCT Number NCT06561100
Lead Sponsor United States Naval Medical Center, San Diego
Conditions
(from sponsor)		 Mild Traumatic Brain Injury
Related terms Brain Concussion
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov