NEUROBALANCE Training to Improve Postural Control in Individuals With Traumatic Brain Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKessler Foundation
About this trial
Our proposed study, \"NEUROBALANCE,\" 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged between 18-75 years
Diagnosed with a non-penetrating TBI at least six months before the screening.
Have complaints of impaired balance and poor postural control determined by a BBS score of ≤50.
Ability to stand upright with or without support for at least 20 seconds
Disqualifiers
Currently undergoing any regular physical therapy program or research studies focusing on balance functions.
Having a stroke or a penetrating TBI.
Affected by the peripheral nerve injury, neuromuscular conditions, or orthopedic issues of lower limbs before TBI, or have any persistent pain or difficulty maintaining blood pressure while upright.
Have a scalp or skin condition (e.g., psoriasis or eczema) on the scalp near the stimulation site.
Trial design
Design model
Parallel
Treatments tested in this trial
Combined (Robotic balance training and high-definition transcranial direct current stimulation)
DeviceThe robotic platform will train the participants to maintain dynamic balance in the sagittal and the transverse planes (mediolateral and anterior-posterior directions) and engage in core stability and trunk control with seated balance exercises. In addition, high-definition transcranial direct current stimulation (HD-tDCS) will be used as an adjuvant to robotic balance training by priming the corticospinal circuits.
Standard of Care Balance Training
Other interventionParticipants in this group will receive a standard-of-care balance training administered by the Physical therapist.
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: RBT + Active HD-tDCS GroupExperimental treatment 1 intervention
Group B: RBT + Sham HD-tDCS GroupSham comparator 1 intervention
Group C: SOC Control GroupOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, post 4-week training, 2-month follow-upSecondary outcomes
1
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.'
Time frame
Baseline, post 4-week training, and 2-month follow-up2
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.
Time frame
Baseline, post 4-week training, and 2-month follow-up3
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.
Time frame
Baseline, post 4-week training, and 2-month follow-up4
Center of Pressure (COP) Displacement
To evaluate the body sway in response to the perturbations of the posturography platform.
Time frame
Baseline, post 4-week training, and 2-month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kessler Foundation
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov