Stroke
Conditions
Keywords
Stroke
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.
Interventions
BEHAVIORALBalance 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.
BEHAVIORALBalance 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessors will not be informed of which group participants are assigned to, and will not be present during an training sessions. As participants will be aware whether or not they will receive sensory augmentation (in the form of vibration), they can not be masked.
Intervention model description
Participants will be randomly assigned to either a Control or an Experimental group. The Experimental group will receive sensory augmentation during balance training, while the Control group will not.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age of at least 21 years; 2. Experience of a stroke at least 6 months prior to participation; 3. Berg Balance Scale score less than 52 4. 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 5. Provision of informed consent
Exclusion criteria
1. Resting blood pressure higher than 220/110 mm Hg 2. History of unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living 3. Pre-existing neurological disorders or dementia 4. Severe visual impairment 5. History of DVT or pulmonary embolism within 6 months 6. Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactJesse C Dean, PhD
Backup ContactAaron E Embry, DPT
Outcome results
None listed