Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
86 participants
INTERVENTIONAL
2021-10-06
2025-12-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Reactive Perturbations
Reactive Perturbations
A novel device will be used to apply controlled mediolateral perturbations to participants' trunk as they walk on a treadmill, requiring reactive responses to avoid a loss of balance. All perturbations will have a duration of 200 ms, and will be applied immediately after onset of the swing phase with either the paretic or non-paretic leg. If in a given training session, a participant does not experience any losses of balance, the perturbation magnitude will be increased in the next training session. Perturbations will begin at 3% body weight (BW), and will progress in increments of 3% BW up to a maximum of 15% BW. The structure of the Reactive perturbation session will be identical to that used for Proactive perturbation training sessions, including overground trials, treadmill trials without perturbations, and Perturbed and Catch trials in which Perturbations are delivered.
Proactive Perturbations
Proactive Perturbations
A novel device will be used to perturb the relationship between pelvis motion and step width by applying mediolateral forces to participants' legs. Participants will first perform a 3-minute overground walking trial at their self-selected speed, in which they do not interact with the perturbation device. Participants will then perform a 3-minute treadmill walking trial at their self-selected speed, in which they again do not interact with the perturbation device. Participants will then perform a series of alternating 3-minute Perturbed and Catch trials, all at their self-selected speed. For the Perturbed trials, perturbations will be delivered in each step throughout the trial. For the Catch trials, perturbations will cease for the final minute of walking. A total of 5 Perturbed and 5 Catch trials will be performed. Finally, participants will perform a 3-minute overground walking trial at their self-selected speed, in which they do not interact with the perturbation device.
Interventions
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Reactive Perturbations
A novel device will be used to apply controlled mediolateral perturbations to participants' trunk as they walk on a treadmill, requiring reactive responses to avoid a loss of balance. All perturbations will have a duration of 200 ms, and will be applied immediately after onset of the swing phase with either the paretic or non-paretic leg. If in a given training session, a participant does not experience any losses of balance, the perturbation magnitude will be increased in the next training session. Perturbations will begin at 3% body weight (BW), and will progress in increments of 3% BW up to a maximum of 15% BW. The structure of the Reactive perturbation session will be identical to that used for Proactive perturbation training sessions, including overground trials, treadmill trials without perturbations, and Perturbed and Catch trials in which Perturbations are delivered.
Proactive Perturbations
A novel device will be used to perturb the relationship between pelvis motion and step width by applying mediolateral forces to participants' legs. Participants will first perform a 3-minute overground walking trial at their self-selected speed, in which they do not interact with the perturbation device. Participants will then perform a 3-minute treadmill walking trial at their self-selected speed, in which they again do not interact with the perturbation device. Participants will then perform a series of alternating 3-minute Perturbed and Catch trials, all at their self-selected speed. For the Perturbed trials, perturbations will be delivered in each step throughout the trial. For the Catch trials, perturbations will cease for the final minute of walking. A total of 5 Perturbed and 5 Catch trials will be performed. Finally, participants will perform a 3-minute overground walking trial at their self-selected speed, in which they do not interact with the perturbation device.
Eligibility Criteria
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Inclusion Criteria
* Self-reported experience of a fall in the previous year, and/or a fear of falling
* Gait speed of at least 0.2 m/s
* Ability to walk on a treadmill without a cane or walker
* 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
* Preexisting neurological disorders or dementia
* Legal blindness or severe visual impairment
* History of DVT or pulmonary embolism within 6 months
* Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
* Orthopedic injuries or conditions (e.g. joint replacements) in the lower extremities with the potential to alter the gait pattern
21 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Medical University of South Carolina
OTHER
Responsible Party
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Jesse Dean
Associate Professor
Principal Investigators
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Jesse Dean
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Locations
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Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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00101810
Identifier Type: -
Identifier Source: org_study_id