Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06584591
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-02
Brief Title:
NEUROBALANCE Training to Improve Postural Control in Individuals with Traumatic Brain Injury
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Neuromodulation-Enhanced Use of RObotic Balance Training to Improve Postural Control in Individuals with Traumatic Brain Injury
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Our proposed study 34NEUROBALANCE34 aims to evaluate the effectiveness of a combined intervention involving robotic balance training and noninvasive brain stimulation in improving balance functions in individuals with chronic traumatic brain injury TBI The study will recruit 45 participants who have had a TBI for over six months and experience persistent balance deficits Participants will be randomized into three groups 1 robotic balance training with active brain stimulation 2 robotic balance training with sham brain stimulation and 3 standard-of-care rehabilitation
The study will involve 12 training sessions over four weeks with assessments conducted at baseline post-training and two months post-training to evaluate balance recovery and retention The primary focus is understanding how this intervention affects brain and muscle activity during balance tasks and how these changes translate into functional improvements in clinical outcome measures of balance function Additionally participant feedback on brain stimulation and exercise engagement will be collected to inform future studies
This research is particularly relevant to military service members as TBI and balance impairments are common among this population The findings may guide the development of personalized training protocols and contribute to broader rehabilitation strategies
The study will involve 12 training sessions over four weeks with assessments conducted at baseline post-training and two months post-training to evaluate balance recovery and retention The primary focus is understanding how this intervention affects brain and muscle activity during balance tasks and how these changes translate into functional improvements in clinical outcome measures of balance function Additionally participant feedback on brain stimulation and exercise engagement will be collected to inform future studies
This research is particularly relevant to military service members as TBI and balance impairments are common among this population The findings may guide the development of personalized training protocols and contribute to broader rehabilitation strategies
Detailed Description:
Background Traumatic Brain Injury TBI is one of the severe health conditions with debilitating consequences affecting more than 25 million individuals in the US alone Balance dysfunction is one of the most disabling outcomes of TBI affecting roughly half of those who have TBI even after ten years have passed after their accident and further it increases the risk of falls due to poor postural control The current challenges are that there are currently no well-established rehabilitation treatments that have been shown to have long-term retention of balance recovery in TBI survivors with chronic balance complaints Therefore we need novel therapeutic strategies using rehabilitation engineering that can target sensorimotor integration and improved proprioceptive control to improve balance function thereby alleviating the long-term burden on TBI survivors and their caregivers
Hypothesis and Rationale We hypothesize that the balance and postural control recovery requires a multimodal strategy and we propose robotic balance training RBT using the Hunova platform Movendo Technology Italy as it has an advantage of supporting dynamic balance in not only sagittal plane but also transverse plane mediolateral and anterior-posterior directions and allows for core stability and trunk control with its unique seated balance exercises In addition we hypothesize that by using high-definition transcranial direct current stimulation HD-tDCS as an adjuvant to RBT HD-tDCS will facilitate top-down neuromuscular control of balance through corticospinal circuits whereas the robotic platform will enable bottom-up feedback of response to platform perturbations Overall we anticipate that the combined intervention will improve reactive and anticipatory postural control position sense and proprioceptive control gain lower-limb strength increase ankle range of motion and stimulate attention through game-like exercises
Study Design We propose a single-center investigator-blinded randomized sham-controlled triple-arm parallel-group superiority trial study Forty-five adult individuals with chronic TBI with complaints of balance dysfunction injury onset gt 6 months before screening will be randomized into one of the three groups 1 Real HD-tDCS RBT 2 Sham HD-tDCS RBT and 3 Control group receiving dose-matched standard of care rehabilitation treatment All participants will undergo 12 sessions 3 days 4 weeks of intervention A total of 3 assessment visits before training immediately after 4-week training and 2-months after the last training visit will be conducted to evaluate the functional recovery and neurophysiological changes due to intervention
Specific Aim-1 To determine whether there is an overall treatment effect of targeted neuromodulation combined with robotic balance training on balance outcomes immediately after 4-week training function in people with TBI The change in Berg Balance Scale score from baseline to 4-week post-training will be the primary outcome measure The secondary outcome measures of balance recovery will be the changes in Mini BESTest Functional Gait Assessment and Trunk Impairment Scale scores from baseline to 4-week post-training We hypothesize that the Real HD-tDCS RBT will show the largest improvement in the balance outcomes
Secondary Aim-2 To characterize the top-down and bottom-up neurophysiological mechanisms of balance control due to neuromodulation-enhanced robotic training We will measure the neurophysiological outcomes of EEG and EMG activity and posturography outcomes of body sway during platform perturbation task at baseline 4-week post-training and 2-month follow-up Specifically the intervention-induced changes in the cortical reactivity amplitude muscle coactivation and center of displacement will be compared across groups
Secondary Aim-3 To study the association between the intervention-related changes in the balance function endpoints and graph-theoretic measures of cortical functional connectivity We will use a multivariate statistical approach-partial least squares correlation-to identify a latent component that characterizes the correlation between the 4-week intervention-related changes in balance outcome measures and EEG corticocortical functional connectivity features measured during platform perturbation task
Hypothesis and Rationale We hypothesize that the balance and postural control recovery requires a multimodal strategy and we propose robotic balance training RBT using the Hunova platform Movendo Technology Italy as it has an advantage of supporting dynamic balance in not only sagittal plane but also transverse plane mediolateral and anterior-posterior directions and allows for core stability and trunk control with its unique seated balance exercises In addition we hypothesize that by using high-definition transcranial direct current stimulation HD-tDCS as an adjuvant to RBT HD-tDCS will facilitate top-down neuromuscular control of balance through corticospinal circuits whereas the robotic platform will enable bottom-up feedback of response to platform perturbations Overall we anticipate that the combined intervention will improve reactive and anticipatory postural control position sense and proprioceptive control gain lower-limb strength increase ankle range of motion and stimulate attention through game-like exercises
Study Design We propose a single-center investigator-blinded randomized sham-controlled triple-arm parallel-group superiority trial study Forty-five adult individuals with chronic TBI with complaints of balance dysfunction injury onset gt 6 months before screening will be randomized into one of the three groups 1 Real HD-tDCS RBT 2 Sham HD-tDCS RBT and 3 Control group receiving dose-matched standard of care rehabilitation treatment All participants will undergo 12 sessions 3 days 4 weeks of intervention A total of 3 assessment visits before training immediately after 4-week training and 2-months after the last training visit will be conducted to evaluate the functional recovery and neurophysiological changes due to intervention
Specific Aim-1 To determine whether there is an overall treatment effect of targeted neuromodulation combined with robotic balance training on balance outcomes immediately after 4-week training function in people with TBI The change in Berg Balance Scale score from baseline to 4-week post-training will be the primary outcome measure The secondary outcome measures of balance recovery will be the changes in Mini BESTest Functional Gait Assessment and Trunk Impairment Scale scores from baseline to 4-week post-training We hypothesize that the Real HD-tDCS RBT will show the largest improvement in the balance outcomes
Secondary Aim-2 To characterize the top-down and bottom-up neurophysiological mechanisms of balance control due to neuromodulation-enhanced robotic training We will measure the neurophysiological outcomes of EEG and EMG activity and posturography outcomes of body sway during platform perturbation task at baseline 4-week post-training and 2-month follow-up Specifically the intervention-induced changes in the cortical reactivity amplitude muscle coactivation and center of displacement will be compared across groups
Secondary Aim-3 To study the association between the intervention-related changes in the balance function endpoints and graph-theoretic measures of cortical functional connectivity We will use a multivariate statistical approach-partial least squares correlation-to identify a latent component that characterizes the correlation between the 4-week intervention-related changes in balance outcome measures and EEG corticocortical functional connectivity features measured during platform perturbation task
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None