Can Early Initiation of Rehabilitation With Wearable Sensor Technology Improve Outcomes in mTBI?
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Balance; Distorted
- Gait, Unsteady
- Mild Traumatic Brain Injury
- Quality of Life
- Veterans
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Investigator, Outcomes Assessor)Masking Description: Single-blinded design.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 60 years
- Gender
- Both males and females
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 i...
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.
Tracking Information
- NCT #
- NCT03479541
- Collaborators
- United States Department of Defense
- Investigators
- Not Provided