NEUROBALANCE Training to Improve Postural Control in Individuals with Traumatic Brain Injury
NCT Number: NCT06584591
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Traumatic Brain Injury|TBI|Diffuse Axonal Brain Injury|Brain Injuries, Traumatic
Sponsor: Kessler Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2027-09

Summary:
Our proposed study, \&#34;NEUROBALANCE,\&#34; 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.

Primary Outcome Measures: Berg Balance Scale (BBS), A widely used outcome measure of static standing balance function (Newstead et al., 2005), categorized under the 'Activity' subsection of ICF domain. BBS scores range from 0 to 56 (the higher, the better). The change in BBS scores from baseline to 4 weeks post-training will be the primary endpoint., Baseline, post 4-week training, 2-month follow-up
Secondary Outcome Measures: Functional Gait Assessment (FGA), To assess dynamic balance during walking, unlike BBS, it is not prone to the ceiling effect(Van Bloemendaal et al., 2019). FGA will be used as the secondary outcome measure of balance function and gait. FGA comes under the ICF domains of 'Activity' and 'Body Function.', Baseline, post 4-week training, and 2-month follow-up|Mini Balance Evaluation Systems Test (MBT), To identify the risk of falls (Yingyongyudha et al., 2016) with a high internal consistency with BBS and similar advantage of FGA, i.e., no ceiling effect. MBT will be used as the secondary endpoint of the balance function., Baseline, post 4-week training, and 2-month follow-up|Trunk Impairment Scale (TIS), To estimate the trunk motor impairment(Verheyden et al., 2004). The scale ranges from 0 to 23 and assesses static and dynamic postural control., Baseline, post 4-week training, and 2-month follow-up|Center of Pressure (COP) Displacement, To evaluate the body sway in response to the perturbations of the posturography platform., Baseline, post 4-week training, and 2-month follow-up|TMS-evoked EEG Potentials (TEP), A neurophysiological outcome measure of cortical reactivity. TEPs can directly measure cortical reactivity without being affected by the distal components of the nervous system, especially in neurological populations(Keser et al., 2022). In contrast to motor-evoked potentials, TEPs also offer the advantage of eliciting cortical responses at TMS intensity below the resting motor threshold., Baseline, post 4-week training, and 2-month follow-up|EEG Corticocortical Functional Connectivity, The imaginary part of coherence (iCOH) measured from the source-space EEG time-series will be used as an outcome measure of corticocortical connectivity, representing sensorimotor functional integration., Baseline, post 4-week training, and 2-month follow-up|EEG-to-EMG Corticomuscular Connectivity, EEG-to-EMG directed transfer function (DTF) will be used as an outcome measure of causal information flow from cortical areas to the leg muscles (Artoni et al., 2017; Peterson \&amp; Ferris, 2019). This measure is intended to capture changes in the efferent communication due to combined interventions., Baseline, post 4-week training, and 2-month follow-up.|EMG Muscle Coactivation, EMG co-contraction index will be used as an outcome measure of muscle activation between the antagonist and agonist muscle pair involved in reactive balance control., Baseline, post 4-week training, and 2-month follow-up.|Quality of Life after Brain Injury (QOLIBRI), A 37-item questionnaire to assess the level of satisfaction with different aspects of Quality of Life (QoL), on a scale of 1 (not at all satisfied) to 5(very satisfied); QOLIBRI is categorized under the ICF domain of 'Participation.', Baseline, post 4-week training, and 2-month follow-up.|Physical Activity Enjoyment Scale (PACES), An 18-item questionnaire with a 7-point Likert scale (higher scores represent increased activity enjoyment) has high reliability and validity(Murrock et al., 2016). The PACES scores will be used during training to assess the enjoyability of the balance exercises., Post 4-week training|Dizziness Handicap Inventory (DHI), A 25-item questionnaire with a 3-point scale to evaluate how dizziness or unsteadiness has affected daily activities in the last month. (Jacobson \&amp; Newman, 1990)., Baseline, post 4-week training, and 2-month follow-up.