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

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.

Conditions

• Mild Traumatic Brain Injury
• Balance; Distorted
• Gait, Unsteady
• Quality of Life
• Veterans

Interventions

BEHAVIORAL

Timing of Rehabilitation

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.

BEHAVIORAL

Biofeedback

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

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• Medical Research Foundation, Oregon

  collaborator OTHER

• Oregon Health and Science University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-07-15

Primary Completion

2023-09-30

Completion

2023-09-30

Countries

• United States

Study Locations