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Can Early Initiation of Rehabilitation With Wearable Sensor Technology Improve Outcomes in mTBI?

N/A
Waitlist Available
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Inclusion criteria will consist of being 1) 18-60 years of age; 2) having minimal cognitive impairment as assessed by the Short Blessed test; and 3) having either a diagnosis of mild traumatic brain injury with persisting symptoms for less than or equal to 12 weeks post-injury for the mild traumatic brain injury (mTBI) group, or no history of mTBI or brain injury within the past year for the control group.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 45 min
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying whether early physical therapy, with or without feedback from wearable sensors, can improve balance in people who have had a mild traumatic brain injury.

Eligible Conditions
  • Veterans
  • Gait Instability
  • Quality of Life
  • Concussion
  • Vestibular Dysfunction

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~45 min
This trial's timeline: 3 weeks for screening, Varies for treatment, and 45 min for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dizziness Handicap Inventory
Secondary study objectives
Auditory Processing
Automated Neuropsychological Assessment Metrics
Central SensoriMotor Integration Test
+10 more
Other study objectives
Buffalo Treadmill Test
Head Impact Test-6
Insomnia Severity Index
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Physical Therapy (Standard of Care)Experimental Treatment1 Intervention
Two sub-arms include "Vestibular Rehabilitation " n=40, and "Vestibular Rehabilitation with Home Monitoring" n=40
Group II: Physical Therapy (Early)Experimental Treatment1 Intervention
Two sub-arms include "Vestibular Rehabilitation " n=40, and "Vestibular Rehabilitation with Home Monitoring" n=40
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rehabilitation
2014
Completed Phase 2
~2510

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
1,008 Previous Clinical Trials
7,414,029 Total Patients Enrolled
1 Trials studying Veterans
140 Patients Enrolled for Veterans
United States Department of DefenseFED
916 Previous Clinical Trials
334,557 Total Patients Enrolled

Media Library

Rehabilitation Clinical Trial Eligibility Overview. Trial Name: NCT03479541 — N/A
Veterans Research Study Groups: Physical Therapy (Early), Physical Therapy (Standard of Care)
Veterans Clinical Trial 2023: Rehabilitation Highlights & Side Effects. Trial Name: NCT03479541 — N/A
Rehabilitation 2023 Treatment Timeline for Medical Study. Trial Name: NCT03479541 — N/A
~22 spots leftby Dec 2025
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