Multisensory Augmentation for Post-stroke Standing Balance
- Conditions
- Stroke
- Interventions
- Behavioral: Balance training with sensory augmentationBehavioral: Balance training
- Registration Number
- NCT05760885
- Lead Sponsor
- VA Office of Research and Development
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 36
- Experience of a stroke at least 6 months prior to participation
- Berg Balance Scale score less than 52
- Ability to stand independently for at least 1 minute without wearing an AFO or other brace that would preclude delivery of stimulation to the ankle or foot sole
- Provision of informed consent
- Resting blood pressure higher than 220/110 mm Hg
- History of unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
- Pre-existing neurological disorders or dementia
- Severe visual impairment
- History of DVT or pulmonary embolism within 6 months
- Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sensory Augmentation Balance training with sensory augmentation Participants will receive sensory augmentation in the form of non-invasive vibration, while balance training is performed as described below. Control Balance training Participants will receive balance training, without any sensory augmentation.
- Primary Outcome Measures
Name Time Method Berg Balance Scale score change Before and after a 10-week period of balance training A standard clinical assessment to measure balance performance during various functional tasks
- Secondary Outcome Measures
Name Time Method Limits of Stability score (paretic direction) Before and after a 10-week period of balance training A standard assessment of how far participants are willing and able to shift their weight toward the paretic leg while standing
Limits of Stability score (non-paretic direction) Before and after a 10-week period of balance training A standard assessment of how far participants are willing and able to shift their weight toward the non-paretic leg while standing
Mediolateral center of pressure displacement Before and after a 10-week period of balance training A measure of sideways sway, which will be quantified as participants stand on a platform that translates sideways, challenging participant balance
Mediolateral center of pressure velocity Before and after a 10-week period of balance training A measure of sideways sway, which will be quantified as participants stand on a platform that translates sideways, challenging participant balance
Trial Locations
- Locations (1)
Ralph H. Johnson VA Medical Center, Charleston, SC
🇺🇸Charleston, South Carolina, United States