Stroke Clinical Trial
Official title:
Reactive Balance Training for Fall Prevention: a Comparative Study of Three Different Perturbation Devices
The objective of this pilot study is to evaluate and compare the effect of three different perturbation based training devices on the reactive balance control among healthy young adults, healthy older adults, and neurologically impaired stroke individuals. Furthermore, the project aims to determine the feasibility and tolerability of 30-minutes of perturbation training using the SureFooted Trainer. Overall, the project directs to find out the long term effect of training on fall risk reduction and fall prevention. This study investigates the effects of perturbation training (slip and trip) based on the principles of motor learning. Perturbations in the form of slips and trips induced by the three different types of perturbation devices will displace the center of mass outside the base of support and challenge the stability, thereby inducing a fall and demand compensatory strategies in order to prevent it. Such perturbation training would train the motor system to improve stability control and vertical limb support. The project design aims to examine the ability of the central nervous system to mitigate the interference in stability control (if any) that is induced by opposing types of perturbations. The hypothesis of this study if supported by the results, will provide the difference in motor learning with training on three different perturbation devices. Furthermore, it would help to determine which of the three training devices is the most effective in developing defense mechanisms necessary to reduce fall-risk among community-living older adults and the neurological population.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | December 31, 2025 |
Est. primary completion date | May 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: Healthy Young participants - Age group: 18-55 years. - Absence of any acute or chronic neurological, cardiopulmonary, musculoskeletal or systemic diagnosis. - No recent major surgery (< 6 months) or hospitalization (< 3 months) - Not on any sedative drugs. - Can understand and communicate in English Healthy older adults - Age group: 56-90 years. - Absence of any acute or chronic neurological, cardiopulmonary, musculoskeletal or systemic diagnosis. - No recent major surgery (< 6 months) or hospitalization (< 3 months) - Not on any sedative drugs. - Ability to walk with or without an assistive device for 10 meters - Can understand and communicate in English - Berg balance scale score <45/56. Persons with stroke - Age group: 18-90 years. - Absence of any acute or chronic neurological diagnosis except stroke (self reported) - Onset of stroke (> 6 months) - Absence of any cardiopulmonary, musculoskeletal or systemic diagnosis. - No recent major surgery (< 6 months) or hospitalization (< 3 months) - Not on any sedative drugs. - Ability to walk with or without an assistive device for 10 meters - Can understand and communicate in English Exclusion Criteria: Healthy subject: - Subjects will not proceed with the test if any of the following occurs at baseline measurement: 1) HR > 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age), 2) systolic blood pressure (SBP) > 165 mmHg and/or diastolic blood pressure (DBP) > 110 mmHg during resting), and 3) oxygen saturation (measured by pulse oximeter) during resting < 95%. - Body weight more than 250 lbs. Healthy Older adults: - Individuals with heel bone density with a T-score < -2, is classified as osteoporotic and will be excluded. - Individuals with mild cognitive impairment (Mini-mental State Exam score < 25/30) will be excluded. - Subjects will not proceed with the test if any of the following occurs at baseline measurement: 1) HR > 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age), 2) systolic blood pressure (SBP) > 165 mmHg and/or diastolic blood pressure (DBP) > 110 mmHg during resting), and 3) oxygen saturation (measured by pulse oximeter) during resting < 95%. - 6 minute walk test. Subjects will also be screened out if on the 6 minute walk test they complain of shortness of breath or uncontrolled pain (> 3/10 on VAS) or pulse oxygen drops < 92% or are unable to achieve the age-specified minimal ambulation distance. - Body weight more than 250 lbs. Persons with stroke: - Individuals with heel bone density with a T-score < -2, is classified as osteoporotic and will be excluded. - Individuals with mild cognitive impairment (Mini-mental State Exam score < 25/30) will be excluded. - Subjects will not proceed with the test if any of the following occurs at baseline measurement: 1) HR > 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age), 2) systolic blood pressure (SBP) > 165 mmHg and/or diastolic blood pressure (DBP) > 110 mmHg during resting), and 3) oxygen saturation (measured by pulse oximeter) during resting < 95%. - 6 minute walk test. Subjects will also be screened out if on the 6 minute walk test they complain of shortness of breath or uncontrolled pain (> 3/10 on VAS) or pulse oxygen drops < 92% or are unable to achieve the age-specified minimal ambulation distance. - Body weight more than 250 lbs. |
Country | Name | City | State |
---|---|---|---|
United States | University of Illinois at Chicago | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Chicago |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Stability gain or loss | Stability is defined by both the position of a person's center-of-mass (COM) with respect to his or her base-of-support (BOS) and it's velocity. | Baseline (1st novel slip, week 1) and at Immediate post-training (after repeated perturbation training session, week 1) | |
Primary | Change in Limb support gain or loss | The inability to provide timely limb support due to insufficient amount of upward impulse generated from the ground reactive force can cause limb collapse, as characterized by the quotient of amount and rate of hip descent (Vhip/Zhip) measured from hip height and lead to an eventual fall. | Baseline (1st novel slip, week 1) and Immediate post-training (after repeated perturbation training session, week 1) | |
Primary | Change in laboratory-induced falls | Perturbation is induced successfully and safely to reproduce inadvertent falls in a protective laboratory environment. Falls will be measured by the amount of body weight supported by the full-body harness system and measured by a load cell attached to this system. Instability of the body's COM and poor limb support prior to touchdown of the recovery step account for 90~100% of subsequent falls (occurring ~500ms later) in both sit-to-stand-slip and in gait-slip, in the laboratory settings. Intervention consists of repeated perturbation training to induce a change in the laboratory induced falls immediately post-training and examine it's retention after the initial training session. | Baseline (1st novel slip, week 1) and Immediate post-training (after repeated perturbation training session, week 1) | |
Primary | Number of Real life falls | Real life falls are measured to determine if training effect can be translated into everyday real life setting. | prospective post-training over next 12 months (total falls tracked and reported at 12 months post-training will be compared between groups) | |
Secondary | Center of mass excursion angle | the deviation of the Center of mass relative to the sagittal plane | Baseline (natural walking) (Week 1), and Virtual reality walking trials at week 1 | |
Secondary | Medio-Lateral excursion of center of mass | The peak excursion of the COM perpendicular to the walking direction | Baseline (natural walking) (Week 1), and Virtual reality walking trials at week 1 | |
Secondary | Change in Number of steps | The total number of steps and distance for each day will be calculated by patient's wearable sensor and their assistive device sensor. This parameter will be used to analyze improvement in physical activity of the patient and decrease reliance on the assistive device. | One month before pretest till prospectively 12 months post training |
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