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

NCT03479541 | Completed Results

• 2 other identifiers: DOD2W81XWH-17-1-0424
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

mild traumatic brain injury; vestibular impairment; balance and gait; dual-tasking; veterans; quality of life; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Dizziness Handicap Inventory (DHI)

  Self-rated questionnaire for dizziness impairment rated on a 3-point scale (0: no; 2: sometimes; 4: always) with a maximum score of 100. Higher scores indicate worse outcome.

  Earlier Physical Therapy (PT) Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14)

Secondary Outcomes (20)

• Neurobehavioral Symptom Inventory (NSI)

  Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14)

• Quality of Life After Brain Injury (QOLIBRI)

  Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14)

• Patient Global Impression of Change (PGIC)

  Earlier PT Group: Post PT (week 7) / Later PT Group: Post PT (week 14)

• Return to Activity Question

  Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14)

• Dynamic Visual Acuity (DVA)

  Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Pre (week 7), and Post Physical Therapy (week 14)

Other Outcomes (3)

• Post-concussion Symptom Scale From the Sport Concussion Assessment (SCAT) Tool Version 5

  Collected weekly throughout study duration (week 0 to week 14).

• Insomnia Severity Index (ISI)

  Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14)

• Head Impact Test (HIT) - 6

  Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14)

Study Arms (4)

Earlier Physical Therapy

EXPERIMENTAL

Within a week of enrollment and baseline testing, participants (n=80) 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.

Behavioral: Timing of Rehabilitation

Later Physical Therapy (Standard of Care)

ACTIVE COMPARATOR

Participants (n=80) will wait 6 weeks after enrollment and baseline testing before starting physical therapy. Before starting physical therapy participants will be re-tested on study outcomes.

Behavioral: Timing of Rehabilitation

Physical Therapy with Home Monitoring

EXPERIMENTAL

Participants (n=80) will start physical therapy after baseline testing and use wearable sensors during home exercise. Feedback was provided later at the next physical therapy session.

Behavioral: Biofeedback

Physical Therapy (without home monitoring)

ACTIVE COMPARATOR

Participants (n=80) will start physical therapy after baseline testing and did not use wearable sensors during home exercise. No feedback of performance was provided.

Behavioral: Biofeedback

Interventions

Timing of Rehabilitation BEHAVIORAL

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.

Earlier Physical Therapy; Later Physical Therapy (Standard of Care)

Biofeedback BEHAVIORAL

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

Physical Therapy (without home monitoring); Physical Therapy with Home Monitoring

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Oregon Health and Science University: lead
• United States Department of Defense: collaborator
• Medical Research Foundation, Oregon: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239-3098, United States

Location

Related Publications (7)

• Faul, M., Xu, L., Wald, M. M., & Coronado, V.G. (2010). Traumatic brain injury in the United States: Emergency Department Visits, Hospitalizations and Deaths 2002-2006. Atlanta, GA: Centers for Disease Control and Prevention, National Center for Injury Prevention and Control. https://www.cdc.gov/traumaticbraininjury/pdf/blue_book.pdf

  BACKGROUND

• Pfaltz CR, Kamath R. Central compensation of vestibular dysfunction. I. Peripheral lesions. Pract Otorhinolaryngol (Basel). 1970;32(6):335-49. doi: 10.1159/000274957. No abstract available.

  PMID: 5313795 BACKGROUND

• Shepard NT, Telian SA. Programmatic vestibular rehabilitation. Otolaryngol Head Neck Surg. 1995 Jan;112(1):173-82. doi: 10.1016/S0194-59989570317-9.

  PMID: 7816453 BACKGROUND

• Campbell KR, Antonellis P, Peterka RJ, Wilhelm JL, Scanlan KT, Pettigrew NC, Chen S, Parrington L, Fino PC, Chesnutt JC, Horak FB, Hullar TE, King LA. In People With Subacute Mild Traumatic Brain Injury, Earlier Physical Therapy Improved Symptoms at a Faster Rate Than Later Physical Therapy: Randomized Controlled Trial. Phys Ther. 2025 Feb 6;105(2):pzae180. doi: 10.1093/ptj/pzae180.

  PMID: 39693261 DERIVED

• Campbell KR, Scanlan KT, Wilhelm JL, Brumbach BH, Pettigrew NC, Neilson A, Parrington L, King LA. Assessment of balance in people with mild traumatic brain injury using a balance systems model approach. Gait Posture. 2023 Feb;100:107-113. doi: 10.1016/j.gaitpost.2022.12.005. Epub 2022 Dec 7.

  PMID: 36516644 DERIVED

• Campbell KR, Wilhelm JL, Pettigrew NC, Scanlan KT, Chesnutt JC, King LA. Implementation and Adoption of Telerehabilitation for Treating Mild Traumatic Brain Injury. J Neurol Phys Ther. 2022 Oct 1;46(4):E1-E10. doi: 10.1097/NPT.0000000000000409. Epub 2022 Jun 6.

  PMID: 35666882 DERIVED

• Parrington L, Jehu DA, Fino PC, Stuart S, Wilhelm J, Pettigrew N, Murchison CF, El-Gohary M, VanDerwalker J, Pearson S, Hullar T, Chesnutt JC, Peterka RJ, Horak FB, King LA. The Sensor Technology and Rehabilitative Timing (START) Protocol: A Randomized Controlled Trial for the Rehabilitation of Mild Traumatic Brain Injury. Phys Ther. 2020 Apr 17;100(4):687-697. doi: 10.1093/ptj/pzaa007.

  PMID: 31951263 DERIVED

MeSH Terms

Conditions

Brain Concussion; Gait Disorders, Neurologic

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Results Point of Contact

• Title: Dr. Laurie King
• Organization: Oregon Health and Science University

kingla@ohsu.edu

5034182602

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Single-blinded design.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: March 27, 2018
• Study Start: July 15, 2018
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: June 24, 2025
• Results First Posted: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)