NCT04205279 Reactive Balance Training for Fall Prevention
| NCT ID | NCT04205279 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Illinois at Chicago |
| Condition | Healthy Young |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2018-02-01 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2018-02-01 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Tanvi Bhatt, PhD
PRINCIPAL INVESTIGATOR
University of Illinois at Chicago
Frequently Asked Questions
Who can join the NCT04205279 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Healthy Young. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04205279 currently recruiting?
Yes, NCT04205279 is actively recruiting participants. Contact the research team at sdusan2@uic.edu for enrollment information.
Where is the NCT04205279 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT04205279 clinical trial?
NCT04205279 is sponsored by University of Illinois at Chicago. The principal investigator is Tanvi Bhatt, PhD at University of Illinois at Chicago. The trial plans to enroll 90 participants.