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

Sponsor

Oregon Health and Science University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03479541

Collaborator

United States Department of Defense (U.S. Fed)

160

Enrollment

Location

Arms

50.5

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mild Traumatic Brain Injury Balance; Distorted Gait, Unsteady Quality of Life Veterans	Behavioral: Rehabilitation	N/A

Detailed Description

Although balance is one of the most common and debilitating complaints after mTBI, the investigators currently lack clear guidelines on when to initiate balance rehabilitation and it is unclear if early physical therapy is beneficial. There is a clear gap in clinical care guidelines after mTBI and it is unclear if initiating rehabilitation early would improve outcomes related to imbalance. Measures of imbalance are subjective and are easily overlooked as a treatable deficit. Even with rehabilitation, recovery of balance in people with mTBI is challenging, particularly in people with central vestibular and sensory integration deficits.

Although vestibular and balance rehabilitation after mTBI relies heavily on a home exercise program and repetition is essential for recovery; The slow progress in balance rehabilitation may be partially due to an inability of people with mTBI to correctly perform the prescribed rehabilitation exercises on their own. Biofeedback is a clinical technique that provides physiologic information that would otherwise be unknown to patients and may improve outcomes after mTBI. There are no commercially available systems to provide the physical therapist and/or patient objective information on the quality of head movements during training of rehabilitation tasks that involve balance and walking.

Therefore, the three objectives of this study are: 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.

160 individuals with acute mTBI within 12 weeks of the injury will be randomly assigned to receive early onset of physical therapy (n=80) right away or be randomly assigned to receive delayed rehabilitation by 3 months in the standard of care physical therapy group (n=80). A subgroup of participants in the early physical therapy (n=40) and standard of care physical therapy (n=40) will be randomly assigned to home monitoring. The participants will wear wireless sensors while completing the rehabilitation program in order to better inform the physiotherapist of their progress.

The outcome measures will consist of a battery of self-reported questionnaires, balance and gait measures, as well as vestibular measures and will be tested at Pre I (baseline), Pre 2 (3 months later for the delayed rehabilitation group), Post (after the intervention), and Retention (3 month follow-up).

The central hypothesis is that rehabilitation after mTBI is suboptimal due to late initiation of and inadequate performance of exercises that do not adequately challenge vestibular and sensory integration function. The long-term goal is to clarify best practices for the rehabilitation of balance deficits in people with mTBI by comparing early vs late (standard of care) initiation of physical therapy with and without wearable sensors on balance deficits after mTBI. 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 Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

Single-blinded design.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 15, 2018

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Physical Therapy (Early) Two sub-arms include "Vestibular Rehabilitation " n=40, and "Vestibular Rehabilitation with Home Monitoring" n=40	Behavioral: Rehabilitation Participants will see a physiotherapist one-on-one twice per week for 2 weeks and once per week for 4 weeks for a total of 6 weeks. These sessions will consist of cardio, cervical flexion exercises and vestibule-ocular exercises for one hour. Participants will also have similar daily home exercises to complete for approximately 30 minutes. Both the one-on-one physiotherapy and home exercises will be individualized and progressive in the sense that each exercise can increase in the level of difficulty at the discretion of the physiotherapist depending on the performance of the participant. For the group allocated to home monitoring, they will perform the vestibular exercises while wearing one wireless sensor on the head and one on the sternum. When the participant brings the sensors in to the physiotherapy session each week, the physiotherapist will examine the home data and likely make a more informed decision as to whether or not to increase the level of difficulty of the task.
Experimental: Physical Therapy (Standard of Care) Two sub-arms include "Vestibular Rehabilitation " n=40, and "Vestibular Rehabilitation with Home Monitoring" n=40	Behavioral: Rehabilitation Participants will see a physiotherapist one-on-one twice per week for 2 weeks and once per week for 4 weeks for a total of 6 weeks. These sessions will consist of cardio, cervical flexion exercises and vestibule-ocular exercises for one hour. Participants will also have similar daily home exercises to complete for approximately 30 minutes. Both the one-on-one physiotherapy and home exercises will be individualized and progressive in the sense that each exercise can increase in the level of difficulty at the discretion of the physiotherapist depending on the performance of the participant. For the group allocated to home monitoring, they will perform the vestibular exercises while wearing one wireless sensor on the head and one on the sternum. When the participant brings the sensors in to the physiotherapy session each week, the physiotherapist will examine the home data and likely make a more informed decision as to whether or not to increase the level of difficulty of the task.

Arm

Intervention/Treatment

Experimental: Physical Therapy (Early)

Two sub-arms include "Vestibular Rehabilitation " n=40, and "Vestibular Rehabilitation with Home Monitoring" n=40

Behavioral: Rehabilitation

Participants will see a physiotherapist one-on-one twice per week for 2 weeks and once per week for 4 weeks for a total of 6 weeks. These sessions will consist of cardio, cervical flexion exercises and vestibule-ocular exercises for one hour. Participants will also have similar daily home exercises to complete for approximately 30 minutes. Both the one-on-one physiotherapy and home exercises will be individualized and progressive in the sense that each exercise can increase in the level of difficulty at the discretion of the physiotherapist depending on the performance of the participant. For the group allocated to home monitoring, they will perform the vestibular exercises while wearing one wireless sensor on the head and one on the sternum. When the participant brings the sensors in to the physiotherapy session each week, the physiotherapist will examine the home data and likely make a more informed decision as to whether or not to increase the level of difficulty of the task.

Experimental: Physical Therapy (Standard of Care)

Two sub-arms include "Vestibular Rehabilitation " n=40, and "Vestibular Rehabilitation with Home Monitoring" n=40

Behavioral: Rehabilitation

Outcome Measures

Primary Outcome Measures

Dizziness Handicap Inventory [5 minutes]
Self-rated questionnaire for dizziness impairment rated on a 3-point scale (0: no; 4: always) with a maximum score of 100

Secondary Outcome Measures

Automated Neuropsychological Assessment Metrics [20 min]
Computer-based test of cognition
Neurobehavioral Symptom Inventory [5 min]
Self-rated questionnaire for symptom severity on a scale from 0 (none) to 4 (very severe) with a maximum score of 88
Quality of Life After Brain Injury [5 min]
Self-rated questionnaire for quality of life questioning satisfaction on a scale from 0 (not at all) to 4 (very) with a maximum score of 168
Patient Global Impression of Change Scale [1 min]
One question rated on a seven point Likert scale (1: no change or condition has gotten worse; 7: a great deal better and a considerable improvement that has made all the difference)
Walking [2 min]
Physical assessment using wearable inertial sensors to quantify sway when walking at a self-selected pace with and without the auditory stroop
Complex Navigation Task [20 min]
Physical assessment using wearable inertial sensors to quantify sway while negotiating a complex course. Participants will walk at a self-selected pace, fast pace, and a self-selected pace while performing the auditory stroop task
Central SensoriMotor Integration Test [45 min]
Physical assessment to quantify sway response to pseudo-random stimuli to calculate sensory weighting and neural controller parameters
Auditory Processing [5 min]
Physical assessment to quantify auditory processing using Spatial Release
Static a Visual Acuity [2 min]
Physical assessment of vision during a Logarithm of the Minimum Angle of Resolution Chart reading, with higher scores indicating worse vision (range: -0.30-1.00)
Dynamic Visual Acuity [2 min]
Physical assessment of vision during a Logarithm of the Minimum Angle of Resolution Chart reading, with higher scores indicating worse vision (range: -0.30-1.00)
Contrast Sensitivity [2 min]
Physical assessment of vision during a Minimum Angle of Resolution Letter Contrast Sensitivity Chart reading, with lower scores indicating worse vision (range: 0.04-1.92)
Vestibular and ocular-motor test (VOMs)-instrumented [10 min]
Physical assessment using eye tracking to assess function of the ocular-motor system, and clinically reporting symptoms of headache, dizziness, nausea, and fogginess during each visual task on a 10-point scale (0: no symptoms; 10 severe symptoms)
Mini-Balance Evaluation Systems Test [20 min]
Physical assessment using wearable inertial sensors to quantify balance and clinically scored on a 3-point scale (0: severe; 2: normal) with a maximum score of 28
Return to Activity Question [1 min]
One question asking participants when they returned to regular daily activities
Modified Balance Error Scoring System (mBESS) [5 min]
Physical assessment using wearable inertial sensors to quantify posture and clinically scored on a scale from 0-10 (0: no errors; 10: 10 or more errors) for each of the three conditions

Other Outcome Measures

Mild Traumatic Brain Injury Screening Form [15 min]
Screening form to describe brain injury
Health Screening Form [20 min]
Screening for health concerns
Cervical Spine Examination performed by a physiotherapist [5 min]
Screening and excluding those with a neck fracture
Ohio State University Traumatic Brain Injury Identification Method [5 min]
Screening form to describe brain injury
Sport Concussion Assessment Tool-2 [5 min]
Screening form to describe brain injury
Vestibular Testing [2.5 hours]
Clinical assessment of vestibular and ocular-motor function as well as hearing tests by an audiologist
Insomnia Severity Index [5 min]
Self-rated questionnaire to rate sleep as a potential covariate for recovery rated on a 5 point scale (0: none; 4: very severe) with a maximum score of 28
Post-Traumatic Stress Disorder-Civilian [5 min]
Self-rated questionnaire to rate PTSD severity as a potential covariate for recovery in civilians rated on a 5-point scale (0: not at all; 5: extremely) with a maximum score of 85
Post-Traumatic Stress Disorder-Military [5 min]
Self-rated questionnaire to rate PTSD severity as a potential covariate for recovery in active duty military personnel rated on a 5-point scale (0: not at all; 5: extremely) with a maximum score of 85
Head Impact Test-6 [5 min]
Self-rated questionnaire to rate headache severity as a potential covariate for recovery rated on a 5-point scale (6: never; 13: always) with a maximum score of 78
Patient Health Questionnaire-9 [5 min]
Self-rated questionnaire to rate depression severity as a potential covariate for recovery rated on a 4-point scale (0: not at all; 3: nearly everyday) with a maximum score of 27
Buffalo Treadmill Test [20 min]
Physical assessment to measure heart rate and symptom score (0: no symptoms; 10: severe symptoms)
Proprioception [5 min]
Clinical assessment of toe proprioception
Pressure Sensitivity [5 min]
Clinical assessment of pressure sensitivity using monofilaments
Patient Reported Outcome Measurement Information System - Pain Interference [2 min]
6-item questionnaire on pain ranging from a scale of one (no pain) to 5 (severe pain) for a maximum total score of 30

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

Exclusion criteria will consist of: 1) any other neurological illness or major surgery causing balance deficits; 2) significant pain during testing; 3) pregnancy; 4) history of balance complaints; 5) peripheral vestibular pathology other than from the mTBI; 6) ocular-motor deficits prior to mTBI; 7) or an inability to abstain from medications that influence balance. All participants will be asked to refrain from taking drugs that may influence balance including sedating antihistamines, benzodiazepines, sedatives, narcotic pain medications and alcohol for at least 24 hours prior to testing.