Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06381674
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-04-04
Brief Title:
Wearable Technology to Characterize and Treat mTBI Subtypes Biofeedback-Based Precision Rehabilitation
Sponsor:
Oregon Health and Science University
Organization:
Oregon Health and Science University
Study Overview
Official Title:
Wearable Technology to Characterize and Treat mTBI Subtypes Biofeedback-Based Precision Rehabilitation
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SuBTyPE
Brief Summary:
Current clinical assessment tools are often not sensitive enough to detect and treat some subtle yet troubling problems after mTBI In this study the investigators will use wearable sensors to both assess and treat people with mTBI Specifically the investigators will provide immediate feedback with visual andor auditory on movement quality during physical therapy This immediate feedback on performance may improve outcomes as the investigators will measure multiple body segments including head movements simultaneously with balance and walking exercises Such complex movements are needed for safe return to high level activity and military duty The investigators will test this approach against a standard vestibular rehabilitation program There are few potential risks to this study such as increasing symptoms and a small fall risk Benefits include physical therapy for balance problems regardless of therapy with or without biofeedback An indirect benefit is to have data on correct dosage of physical therapy The investigators will also distinguish which concussion subtype profiles benefit most from physical therapy This will help healthcare providers and patients by providing more information to help establish clinical guidelines and new tools for physical therapy
Detailed Description:
Mild traumatic brain injury mTBI is common and can cause long-term problems Balance problems are one of the most common problems and can prevent people from returning to their previous quality of life People with mTBI can have many symptoms that present differently ie subtypes making it difficult to evaluate and treat Subtypes include cognitive ocular-motor vision problems headache vestibular balance and dizziness and mood Correct detection of subtypes is important for patients to get the best and most specific to their subtype care as quickly as possible Our group has expertise in the subtypes that could likely affect balance and gait vestibular and ocular-motor VO and investigators plan to use wearable sensors and objective measures to improve detection and treatment of the problems that commonly occur in these subtypes The investigators will test an approach multi-segmental biofeedback using wearable sensors that can measure how people move overall and can provide immediate feedback on how multiple body segments move during vestibular rehabilitation Specifically these sensors can provide feedback on head and body movement and speed but also measure how stable balance and walking are during an exercise The investigators believe real-time feedback during the exercises will improve the quality of rehabilitation specifically for those patients with VO subtypes The investigators also want to explore whether people with VO subtypes move differently in the real world The investigators will do this by measuring daily life mobility over 7 days using wearable sensors
The Aims of this project are
1 Aim I Multidimensional real-time biofeedback for rehabilitation To determine if multidimensional real-time biofeedback using novel wearable technology that measures headtrunk and balancegait improves outcomes after rehabilitation compared to standard care For this aim the investigators will enroll 100 participants 50 from Oregon Health Science University and 50 from University of Utah People will be randomized into either vestibular physical therapy augmented with visualaudio real-time biofeedback or into vestibular therapy without real-time biofeedback Participants will be tested before and after a 6-week 2xweek rehabilitation program Our primary outcome will be the Patient Global Impression of Change PGIC Secondary outcomes will include Subjective Patient-reported Clinical Assessment and Instrumented Assessment measures
2 Responsiveness to rehabilitation objective measures to identify VO subtype Aim II is a separate analysis based on the data collected in Aim I For this Aim the 100 participants from Aim 1 will be grouped according to severity of VO symptoms Here the investigators will explore a the responsiveness to rehabilitation by level of VO deficit and b the strength of the relationship between Patient-reported and Clinical and Instrumented Assessments of VO measures
3 Daily life mobility in people with VO subtype To a determine if daily life mobility quality of gait and turning is impacted differently in people with high VO deficits and b calculate healthy normative data for daily life mobility measures in active duty military service members For Aim III 50 people from Aim I divided equally with VO HI and VO LO will wear instrumented socks APDM Wearable Technologies over 7 days Daily life mobility quantity and quality will also be collected on 40 healthy active duty service members over 7 days at Fort Sam Houston FSH to facilitate next steps in using continuous monitoring as an outcome measure after mTBI in the military
The Aims of this project are
1 Aim I Multidimensional real-time biofeedback for rehabilitation To determine if multidimensional real-time biofeedback using novel wearable technology that measures headtrunk and balancegait improves outcomes after rehabilitation compared to standard care For this aim the investigators will enroll 100 participants 50 from Oregon Health Science University and 50 from University of Utah People will be randomized into either vestibular physical therapy augmented with visualaudio real-time biofeedback or into vestibular therapy without real-time biofeedback Participants will be tested before and after a 6-week 2xweek rehabilitation program Our primary outcome will be the Patient Global Impression of Change PGIC Secondary outcomes will include Subjective Patient-reported Clinical Assessment and Instrumented Assessment measures
2 Responsiveness to rehabilitation objective measures to identify VO subtype Aim II is a separate analysis based on the data collected in Aim I For this Aim the 100 participants from Aim 1 will be grouped according to severity of VO symptoms Here the investigators will explore a the responsiveness to rehabilitation by level of VO deficit and b the strength of the relationship between Patient-reported and Clinical and Instrumented Assessments of VO measures
3 Daily life mobility in people with VO subtype To a determine if daily life mobility quality of gait and turning is impacted differently in people with high VO deficits and b calculate healthy normative data for daily life mobility measures in active duty military service members For Aim III 50 people from Aim I divided equally with VO HI and VO LO will wear instrumented socks APDM Wearable Technologies over 7 days Daily life mobility quantity and quality will also be collected on 40 healthy active duty service members over 7 days at Fort Sam Houston FSH to facilitate next steps in using continuous monitoring as an outcome measure after mTBI in the military
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HT9425-23-1-0845 | OTHER_GRANT | Department of Defense | None |