CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 203 enrolled
Drug / intervention
Timing of Rehabilitation +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/NCT03479541
NCT03479541N/ACompleted

Sensory Integration Balance Deficits in Complex mTBI: Can Early Initiation of Rehabilitation With Wearable Sensor Technology Improve Outcomes?

Oregon Health and Science University·interventional·Posted Mar 27, 2018·Updated Jun 24, 2025

In Brief

A clinical study evaluating Timing of Rehabilitation and Biofeedback for Mild Traumatic Brain Injury and 4 related conditions. Completed, enrolled 203 participants across 1 site.

Detailed Summary

Every year 1.7 million people sustain a traumatic brain injury (TBI) in the United States and of these, 84 % are considered mild TBI (mTBI). mTBI is common both in civilian and military populations and can be debilitating if symptoms do not resolve after injury. Balance problems are one of the most common complaints after sustaining a mTBI and often prevent individuals from returning to their previous quality of life. However, the investigators currently lack clear guidelines on when to initiate physical therapy rehabilitation and it is unclear if early physical therapy is beneficial. The investigators believe that the underlying problem of imbalance results from damage to parts of the brain responsible for interpreting sensory information for balance control. The investigators hypothesize that retraining the brain early, as opposed to months after injury, to correctly interpret sensory information will improve recovery. The investigators also believe this retraining is limited when rehabilitation exercises are performed incorrectly, and that performance feedback from wearable sensors, can improve balance rehabilitation. There are three objectives of this study: 1) to determine how the timing of rehabilitation affects outcomes after mTBI; 2) to determine if home monitoring of balance exercises using wearable sensors improves outcomes; and 3) to develop a novel feedback system using wearable sensors to provide the physical therapist information, in real-time during training, about quality of head and trunk movements during prescribed exercises. The findings from this research could be very readily adopted into military protocols for post-mTBI care and have the potential to produce better balance rehabilitation and quality of life for mTBI patients and their families.

Study Details

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

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMar 27, 2018
Enrollment StartJul 15, 2018
Primary CompletionSep 30, 2023
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 8.3 years ago

Interventions

Timing of Rehabilitationbehavioral

Participants in the Earlier Physical Therapy group will start physical therapy within a week of enrollment and baseline testing. Participants allocated to the Later Physical Therapy group will wait 6 weeks after enrollment and baseline testing before starting physical therapy, and re-test on study outcomes before starting physical therapy. Both groups will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each session will last 60 minutes and consist of cardiovascular, cervical spine, and vestibular therapy exercises (static and dynamic balance). Participants will perform daily home exercises for 30 minutes with similar subcategories from the in-person sessions. Both the in-person physical therapy and home exercises will be individualized and progressive at the discretion of the physical therapist depending on the performance of the participant.

Biofeedbackbehavioral

Wearable sensors measure movement during the home exercise program for later feedback.