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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03479541
• Other study ID #: DOD2
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 15, 2018
• Est. completion date: September 30, 2023

Study information

• Verified date: May 2023
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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, and balance and gait 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). Vestibular measures will occur at the baseline visit only. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Balance; Distorted
• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Gait Disorders, Neurologic
• Gait, Unsteady
• Mild Traumatic Brain Injury
• Quality of Life
• Veterans

Intervention

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.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sport Concussion Assessment Tool-2	Screening form to describe brain injury	5 min
Other	Insomnia Severity Index	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	5 min
Other	Head Impact Test-6	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	5 min
Other	Buffalo Treadmill Test	Physical assessment to measure heart rate and symptom score (0: no symptoms; 10: severe symptoms)	20 min
Primary	Dizziness Handicap Inventory	Self-rated questionnaire for dizziness impairment rated on a 3-point scale (0: no; 4: always) with a maximum score of 100	5 minutes
Secondary	Automated Neuropsychological Assessment Metrics	Computer-based test of cognition	20 min
Secondary	Neurobehavioral Symptom Inventory	Self-rated questionnaire for symptom severity on a scale from 0 (none) to 4 (very severe) with a maximum score of 88	5 min
Secondary	Quality of Life After Brain Injury	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	5 min
Secondary	Patient Global Impression of Change Scale	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)	1 min
Secondary	Walking	Physical assessment using wearable inertial sensors to quantify sway when walking at a self-selected pace with and without the auditory stroop	2 min
Secondary	Complex Navigation Task	Physical assessment using wearable inertial sensors to quantify sway while negotiating a complex course. Participants will walk at a self-selected pace and fast pace and while performing the auditory stroop task (only during self-selected pace.	20 min
Secondary	Central SensoriMotor Integration Test	Physical assessment to quantify sway response to pseudo-random stimuli to calculate sensory weighting and neural controller parameters	45 min
Secondary	Auditory Processing	Physical assessment to quantify auditory processing using Spatial Release	5 min
Secondary	Dynamic Visual Acuity	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)	2 min
Secondary	Vestibular and ocular-motor test (VOMs)-instrumented	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)	10 min
Secondary	Mini-Balance Evaluation Systems Test	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	20 min
Secondary	Return to Activity Question	One question asking participants when they returned to regular daily activities	1 min
Secondary	Modified Balance Error Scoring System (mBESS)	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	5 min