Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06314464
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-18
First Post:
2024-02-29
Brief Title:
Portable Mixed Reality-based Platform for Assessment of Progress in Multisensory Rehabilitation Strategies Post-TBI
Sponsor:
BlueHalo
Organization:
BlueHalo
Study Overview
Official Title:
Portable Mixed Reality-based Platform for Assessment of Progress in Multisensory Rehabilitation Strategies for Post-TBI Return-to-duty RTD Decision Making Praxis
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
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:
Praxis
Brief Summary:
The goal of this comparative pilot study is to provide evidence that Praxis a portable testbed with low-cost wearable sensors and a mixed reality environment can deliver effective multisensory rehabilitation exercises with military face-validity in a military service member SM population after mild Traumatic Brain Injury mTBI
The main questions this comparative pilot study aims to answer are
Can the Praxis testbed provide feasibleacceptable 4-week multisensory rehabilitation for SMs with post-acute mTBI
Can Praxis detect and influence measurable changes in readiness performance during mTBI recovery
Fifteen SMs with post-acute mTBI from the Center for the Intrepids Special Operations Performance and Recovery SPaR Program will participate in the multisensory vestibular rehabilitation regimen These SMs will go through 4 weeks of multisensory vestibular rehabilitation including
gaze stabilization
dual-task balance training
spatial navigation
agility training
Data from another fifteen SMs who will not go through the multisensory rehabilitation regimen and will receive supervised cardiovascular exercise will be used as the control group
Researchers will compare the Praxis and Control group to determine if the Praxis group shows improvement over the control group with respect to the military-relevant behavioral performance outcomes and patient-reported symptom scores after the end of the rehabilitation
The main questions this comparative pilot study aims to answer are
Can the Praxis testbed provide feasibleacceptable 4-week multisensory rehabilitation for SMs with post-acute mTBI
Can Praxis detect and influence measurable changes in readiness performance during mTBI recovery
Fifteen SMs with post-acute mTBI from the Center for the Intrepids Special Operations Performance and Recovery SPaR Program will participate in the multisensory vestibular rehabilitation regimen These SMs will go through 4 weeks of multisensory vestibular rehabilitation including
gaze stabilization
dual-task balance training
spatial navigation
agility training
Data from another fifteen SMs who will not go through the multisensory rehabilitation regimen and will receive supervised cardiovascular exercise will be used as the control group
Researchers will compare the Praxis and Control group to determine if the Praxis group shows improvement over the control group with respect to the military-relevant behavioral performance outcomes and patient-reported symptom scores after the end of the rehabilitation
Detailed Description:
This study considers Praxis a portable testbed with low-cost wearable sensors and a mixed reality environment to deliver effective multisensory rehabilitation exercises with military face-validity Through a small comparative pilot study the investigators plan to provide evidence for future multi-center randomized trials MCRTs to show that progress in these multisensory exercises correlates with established military readiness assessments and that the improvements in functional performance in response to multisensory rehabilitation strategies is associated with changes in brain activity
In preparation for an MCRT the investigators will conduct a pilot study to examine and settle the issues of feasibility and effectiveness of protocol implementation in accordance with best practices In this study we
deliver a well-defined rehabilitation strategy via the Praxis system to the enable the patient to practice challenging rehabilitation tasks
assess changes in neurophysiological activity via resting state functional magnetic resonance imaging rs-fMRI over time in relation to the intensity of the rehabilitation strategy and
assess sensitive behavioral outcome measures that monitor the SMs functional gains over time via a battery of military-relevant tasks
Fifteen SMs with post-acute mTBI from the Center for the Intrepids Special Operations Performance and Recovery SPaR Program will participate in the multisensory vestibular rehabilitation regimen These SMs will go through 4 weeks of multisensory vestibular rehabilitation
gaze stabilization
dual-task balance training
spatial navigation
agility training
Data from another fifteen SMs who will not go through the multisensory rehabilitation regimen and will receive supervised cardiovascular exercise will be used as the control group
The first purposes of this study are to demonstrate the feasibility of obtaining a representative sample of SMs with and without vestibularocular impairments post-mTBI in a Special Operations population determine whether the data is collected reliably and establish compliance with the protocol in the 4-week study timeline The primary endpoints for this study are feasibilityacceptability of the 4-week multisensory rehabilitation for SMs with post-acute mTBI as determined by compliance to daily rehabilitation doses as verified by the VestAid software and acceptability measured by the System Usability Scale SUS with success thresholds set at 80 or more of the target population completing all the doses and an average total score of 68 or above on the SUS assessment
The second purpose of this study is to determine the average values and variations of the behavioral outcome measures before and after multisensory rehabilitation delivered by Praxis as well as the changes in neurophysiological activity and the correlation between the two The investigators will use this information to determine the sample size required for a future larger multicenter study
The investigators aim to evaluate the effect size relating the implicated functional changes to recovery over the 4-week rehabilitation period in the military population under study The secondary endpoints of this pilot study will comprise preliminary statistical insights into the ability of Praxis to detect and influence measurable changes in readiness performance during mTBI recovery The collected metrics include longitudinal Praxis compliance score pre- and post- behavioral outcome measurements from the readiness battery and patient-perceived disability questionnaires Between-group analyses will be conducted to determine the effect size of the Praxis protocol on both the military-relevant behavioral outcomes as well as the patient-reported symptom scores Within the Praxis group the investigators will perform an exploratory analysis to examine the correlations between the military-relevant behavioral outcome scores Praxis compliance scores and previously implicated objective neurophysiological measures
In preparation for an MCRT the investigators will conduct a pilot study to examine and settle the issues of feasibility and effectiveness of protocol implementation in accordance with best practices In this study we
deliver a well-defined rehabilitation strategy via the Praxis system to the enable the patient to practice challenging rehabilitation tasks
assess changes in neurophysiological activity via resting state functional magnetic resonance imaging rs-fMRI over time in relation to the intensity of the rehabilitation strategy and
assess sensitive behavioral outcome measures that monitor the SMs functional gains over time via a battery of military-relevant tasks
Fifteen SMs with post-acute mTBI from the Center for the Intrepids Special Operations Performance and Recovery SPaR Program will participate in the multisensory vestibular rehabilitation regimen These SMs will go through 4 weeks of multisensory vestibular rehabilitation
gaze stabilization
dual-task balance training
spatial navigation
agility training
Data from another fifteen SMs who will not go through the multisensory rehabilitation regimen and will receive supervised cardiovascular exercise will be used as the control group
The first purposes of this study are to demonstrate the feasibility of obtaining a representative sample of SMs with and without vestibularocular impairments post-mTBI in a Special Operations population determine whether the data is collected reliably and establish compliance with the protocol in the 4-week study timeline The primary endpoints for this study are feasibilityacceptability of the 4-week multisensory rehabilitation for SMs with post-acute mTBI as determined by compliance to daily rehabilitation doses as verified by the VestAid software and acceptability measured by the System Usability Scale SUS with success thresholds set at 80 or more of the target population completing all the doses and an average total score of 68 or above on the SUS assessment
The second purpose of this study is to determine the average values and variations of the behavioral outcome measures before and after multisensory rehabilitation delivered by Praxis as well as the changes in neurophysiological activity and the correlation between the two The investigators will use this information to determine the sample size required for a future larger multicenter study
The investigators aim to evaluate the effect size relating the implicated functional changes to recovery over the 4-week rehabilitation period in the military population under study The secondary endpoints of this pilot study will comprise preliminary statistical insights into the ability of Praxis to detect and influence measurable changes in readiness performance during mTBI recovery The collected metrics include longitudinal Praxis compliance score pre- and post- behavioral outcome measurements from the readiness battery and patient-perceived disability questionnaires Between-group analyses will be conducted to determine the effect size of the Praxis protocol on both the military-relevant behavioral outcomes as well as the patient-reported symptom scores Within the Praxis group the investigators will perform an exploratory analysis to examine the correlations between the military-relevant behavioral outcome scores Praxis compliance scores and previously implicated objective neurophysiological measures
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