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| ID | Type | Description | Link |
|---|---|---|---|
| I01RX004545 | U.S. NIH Grant/Contract | View source |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sensory Augmentation | Experimental | Participants will receive sensory augmentation in the form of non-invasive vibration, while balance training is performed as described below. |
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| Control | Active Comparator | Participants will receive balance training, without any sensory augmentation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balance training with sensory augmentation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Berg Balance Scale score change | A standard clinical assessment to measure balance performance during various functional tasks | Before and after a 10-week period of balance training |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Before and after a 10-week period of balance training |
| Limits of Stability score (non-paretic direction) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jesse C Dean, PhD | Contact | (843) 792-9566 | Jesse.Dean@va.gov | |
| Aaron E Embry, DPT | Contact | (843) 792-8198 | Aaron.Embry@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Jesse C. Dean, PhD | Ralph H. Johnson VA Medical Center, Charleston, SC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ralph H. Johnson VA Medical Center, Charleston, SC | Recruiting | Charleston | South Carolina | 29401-5703 | United States |
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.
We will share de-identified data upon study results publication, which we anticipate will happen within one year after study completion. Data will remain available in perpetuity.
All consumers of the scientific literature will have access to the shared de-identified data.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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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.
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| Balance training | Behavioral | 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. |
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A standard assessment of how far participants are willing and able to shift their weight toward the non-paretic leg while standing |
| 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 | 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 | Before and after a 10-week period of balance training |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |