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| ID | Type | Description | Link |
|---|---|---|---|
| REGE22000170 | Other Grant/Funding Number | NIDILRR |
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| Name | Class |
|---|---|
| National Institute on Disability, Independent Living, and Rehabilitation Research | FED |
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Many people who have experienced a stroke have deficits in their walking balance. The long-term goal of this research is to develop an exoskeleton that can effectively improve walking balance, thus improving functional mobility.
Walking balance is an important component of functional mobility, with post-stroke balance deficits contributing to a fall rate more than double that of age-matched controls. Unfortunately, traditional therapy approaches have not succeeded in addressing balance deficits or reducing fall risk, motivating the use of technology to fill this gap. Although assistive exoskeletons are a promising approach to improve post-stroke mobility, they have generally not been designed to control walking balance and agility. This limitation is a particular concern in the development of devices for people with stroke, as applying forces to "assist" some aspect of walking (including balance) can have unexpected negative effects. The project goal is to investigate the potential of exoskeleton assistance to improve walking balance that will be accepted by people with stroke. To this end, investigators will use a previously developed hip exoskeleton to quantify the effects of assisting gait stabilization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| xoskeleton Assistance Conditions (No Exoskeleton, Zero, Low, Medium, High Impedance) | Experimental | Participants in this arm will walk on a treadmill under several conditions. In one condition, they will not wear the exoskeleton. In other conditions, the exoskeleton will be set to zero, low, medium, or high impedance. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Exoskeleton | Device | The participant will not wear an exoskeleton |
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| Measure | Description | Time Frame |
|---|---|---|
| Partial correlation (rSW) between mediolateral pelvis displacement and step width during unperturbed walking | Mediolateral pelvis displacement will be quantified at the start of each step, and step width will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently. | Visit 2, anticipated average 1 week |
| Partial correlation (rSW) between mediolateral pelvis displacement and step width during speed perturbations | Mediolateral pelvis displacement will be quantified at the start of each step, and step width will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently. | Visit 4, anticipated average 1 year |
| Partial correlation (rSW) between mediolateral pelvis displacement and step width during vision perturbations | Mediolateral pelvis displacement will be quantified at the start of each step, and step width will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently. | Visit 4, anticipated average 1 year |
| Partial correlation (rSW) between mediolateral pelvis displacement and step width during mediolateral pull perturbations | Mediolateral pelvis displacement will be quantified at the start of each step, and step width will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently. | Visit 4, anticipated average 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Partial correlation between mediolateral pelvis displacement and mediolateral foot placement (unperturbed walking) | Mediolateral pelvis displacement will be quantified at the start of each step, and mediolateral foot placement relative to the pelvis will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jesse C. Dean, PhD | Contact | 8437929566 | deaje@musc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
All collected IPD that underlie results in a publication will be shared.
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Relevant IPD and supporting information will be available within one year from when data is published, and will be available in perpetuity.
Relevant IPD and supporting information will be shared through an accessible server online. Our current plan is to use the NIH BRICS data depository.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 31, 2025 | Dec 8, 2025 | Prot_SAP_000.pdf |
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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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All participants will experience the same series of experimental sessions. Within individual sessions, the order in which different exoskeleton conditions are tested will be randomized.
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| Exoskeleton (zero impedance) | Device | The participant will wear an exoskeleton with zero impedance |
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| Exoskeleton (low impedance) | Device | The participant will wear an exoskeleton with low joint impedance |
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| Exoskeleton (medium impedance) | Device | The participant will wear an exoskeleton with medium joint impedance |
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| Exoskeleton (high impedance) | Device | The participant will wear an exoskeleton with high impedance |
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| Visit 2, anticipated average 1 week |
| Average gluteus medius activity during stance phase (surface EMG) in unperturbed walking | Average gluteus medius EMG activity will be calculated during the stance phase of walking. This will be calculated for each leg independently. | Visit 2, anticipated average 1 week |
| Average gluteus medius activity during swing phase (surface EMG) in unperturbed walking | Average gluteus medius EMG activity will be calculated during the swing phase of walking. This will be calculated for each leg independently. | Visit 2, anticipated average 1 week |
| Rating of Perceived Stability (RPS) during unperturbed walking | This patient reported outcome measure uses a validated scale for participants to self-report their perceived balance while walking. | Visit 2, anticipated average 1 week |
| Partial correlation between mediolateral pelvis displacement and mediolateral foot placement during speed perturbations | Mediolateral pelvis displacement will be quantified at the start of each step, and mediolateral foot placement relative to the pelvis will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently. | Visit 4, anticipated average 1 year |
| Average gluteus medius activity during stance phase (surface EMG) with speed perturbations | Average gluteus medius EMG activity will be calculated during the stance phase of walking. This will be calculated for each leg independently. | Visit 4, anticipated average 1 year |
| Average gluteus medius activity during swing phase (surface EMG) with speed perturbations | Average gluteus medius EMG activity will be calculated during the swing phase of walking. This will be calculated for each leg independently. | Visit 4, anticipated average 1 year |
| Rating of Perceived Stability (RPS) with speed perturbations | This patient reported outcome measure uses a validated scale for participants to self-report their perceived balance while walking. | Visit 4, anticipated average 1 year |
| Partial correlation between mediolateral pelvis displacement and mediolateral foot placement during vision perturbations | Mediolateral pelvis displacement will be quantified at the start of each step, and mediolateral foot placement relative to the pelvis will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently. | Visit 4, anticipated average 1 year |
| Average gluteus medius activity during stance phase (surface EMG) with vision perturbations | Average gluteus medius EMG activity will be calculated during the stance phase of walking. This will be calculated for each leg independently. | Visit 4, anticipated average 1 year |
| Average gluteus medius activity during swing phase (surface EMG) with vision perturbations | Average gluteus medius EMG activity will be calculated during the swing phase of walking. This will be calculated for each leg independently. | Visit 4, anticipated average 1 year |
| Rating of Perceived Stability (RPS) with vision perturbations | This patient reported outcome measure uses a validated scale for participants to self-report their perceived balance while walking. | Visit 4, anticipated average 1 year |
| Partial correlation between mediolateral pelvis displacement and mediolateral foot placement during mediolateral pull perturbations | Mediolateral pelvis displacement will be quantified at the start of each step, and mediolateral foot placement relative to the pelvis will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently. | Visit 4, anticipated average 1 year |
| Average gluteus medius activity during stance phase (surface EMG) with mediolateral pull perturbations | Average gluteus medius EMG activity will be calculated during the stance phase of walking. This will be calculated for each leg independently. | Visit 4, anticipated average 1 year |
| Average gluteus medius activity during swing phase (surface EMG) with mediolateral pull perturbations | Average gluteus medius EMG activity will be calculated during the swing phase of walking. This will be calculated for each leg independently. | Visit 4, anticipated average 1 year |
| Rating of Perceived Stability (RPS) with mediolateral pull perturbations | This patient reported outcome measure uses a validated scale for participants to self-report their perceived balance while walking. | Visit 4, anticipated average 1 year |
| Change in mediolateral foot placement (cm) during pull perturbations relative to unperturbed steps | The change in mediolateral foot placement locations between steps with and without pull perturbations will be calculated. This will be calculated separately for steps taken with each leg. | Visit 4, anticipated average 1 year |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |