MAB: Multisensory Augmentation for Post-stroke Standing Balance
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sensory Augmentation 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 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.
|
| Active Comparator: Control 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, no sensory stimulation will be delivered. The difficulty of the balance training task will progressively increase over successive training sessions.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ralph H. Johnson VA Medical Center, Charleston, SC | Charleston | South Carolina | United States | 29401-5703 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Principal Investigator: Jesse C. Dean, PhD, Ralph H. Johnson VA Medical Center, Charleston, SC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- A4545-R
- I01 RX004545