An Early Phase 1 interventional study of Balance training with sensory augmentation and Balance training in Stroke, sponsored by VA Office of Research and Development. Recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by VA Office of Research and Development · Early Phase 1, Interventional, and Treatment
Many individuals who experience a stroke have problems with their balance. In part, these balance problems may be due to sensory issues. This study will test whether sensory augmentation has the potential to improve post-stroke balance. Sensory augmentation is a method by which non-invasive vibration is used to enhance the sensory information available to users, which may make it easier to feel where they are and prevent losses of balance.
The objective of this study is to design a novel multisensory augmentation approach to improve the control of standing balance in people with chronic stroke. With sensory augmentation, artificial feedback provides the nervous system with information about the dynamic state of the body, which can be used to prevent losses of balance. This clinical trial will investigate whether multisensory augmentation produces sustained balance improvements when applied as a training device. These potential improvements will be assessed by comparing the results of clinical and biomechanical assessments before and after a 10-week balance training program, in which half of the participants will be randomly assigned sensory augmentation.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 36 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive sensory augmentation in the form of non-invasive vibration, while balance training is performed as described below.
Behavioral: Balance training with sensory augmentation
Participants will receive balance training, without any sensory augmentation.
Behavioral: Balance training
Participants will complete 20 balance training sessions, in which they are required to keep their balance while standing on a platform that translates under their feet. During training, sensory augmentation will be delivered with an intensity controlled in real-time by their center of pressure motion. The difficulty of the balance training task will progressively increase over successive training sessions.
Participants will complete 20 balance training sessions, in which they are required to keep their balance while standing on a platform that translates under their feet. During training, no sensory stimulation will be delivered. The difficulty of the balance training task will progressively increase over successive training sessions.
Berg Balance Scale score change
A standard clinical assessment to measure balance performance during various functional tasks
Time frame: Before and after a 10-week period of balance training
Limits of Stability score (paretic direction)
A standard assessment of how far participants are willing and able to shift their weight toward the paretic leg while standing
Time frame: Before and after a 10-week period of balance training
Limits of Stability score (non-paretic direction)
A standard assessment of how far participants are willing and able to shift their weight toward the non-paretic leg while standing
Time frame: Before and after a 10-week period of balance training
Mediolateral center of pressure displacement
A measure of sideways sway, which will be quantified as participants stand on a platform that translates sideways, challenging participant balance
Time frame: Before and after a 10-week period of balance training
Mediolateral center of pressure velocity
A measure of sideways sway, which will be quantified as participants stand on a platform that translates sideways, challenging participant balance
Time frame: Before and after a 10-week period of balance training
Plan to share: Yes — We plan to share de-identified data that contains no protected participant information. This data will be shared in the form of pre-prints and through online servers upon study results publication.
Supporting information: Study protocol, Icf
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