Multisensory Augmentation for Post-stroke Standing Balance
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Balance training with sensory augmentation, Balance training.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multisensory Augmentation to Improve the Standing Balance of People With Chronic Stroke
Overview
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.
Interventions
- Behavioral Balance training with sensory augmentation
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. - 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, no sensory stimulation will be delivered. The difficulty of the balance training task will progressively increase over successive training sessions.
Primary outcome measures
- Berg Balance Scale score change [Time frame: Before and after a 10-week period of balance training]
Secondary outcome measures (4)
- Limits of Stability score (paretic direction) [Time frame: Before and after a 10-week period of balance training]
- Limits of Stability score (non-paretic direction) [Time frame: Before and after a 10-week period of balance training]
- Mediolateral center of pressure displacement [Time frame: Before and after a 10-week period of balance training]
- Mediolateral center of pressure velocity [Time frame: Before and after a 10-week period of balance training]
Eligibility criteria
Inclusion criteria
- Age of at least 21 years;
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Ralph H. Johnson VA Medical Center, Charleston, SC — Charleston
Identifiers
NCT: NCT05760885 · A4545-R · I01RX004545