Aging and Mixed Perturbation Training to Reduce Falls in Locomotion

August 12, 2025 updated by: Tanvi Bhatt, University of Illinois at Chicago
The long-term objective of this research is to develop an efficacious training paradigm to enhance older adults' defense mechanisms against falls and possibility reduce healthcare cost. The Centers for Disease Control and Prevention estimates the direct medical cost for fall related injuries to be $30 billion annually. Slips and trips combined account for more than 50% of the outdoor falls in community-dwelling older adults. These environmental perturbations are opposing in nature, with slips mainly resulting in backward falls and trips in forward falls. This project explores perturbation training through both slip and trip exposure based on the principles of motor learning. The project design consists of a randomized controlled trial 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. It also introduces a novel combined slip and trip perturbation training paradigm to enhance one's ability to retain and generalize the acquired fall-prevention skills to both types of falls. Slips and trips induced on an over ground walkway will be used to prepare the motor system to improve stability control and vertical limb support to resist falls. The longer-term benefits of such combined perturbation training over exclusive slip-only or trip-only perturbation training in reducing both laboratory-induced and real life falls will also be assessed. The hypothesis of this study if supported by the results will provide an evidence-supported training protocol to reduce the fall-risk among community-dwelling older adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Impaired or delayed reactive postural responses pose a potential threat to falls while walking resulting in slips or trips in older and neurologically impaired individuals. Therefore, increase in understanding of postural responses to unexpected external perturbation in older adults and people with neurological diseases will lead to development of new therapeutic approaches for fall prevention in this population. The overall objective of this is to investigate the dynamic stability during slip and trip-like experiences by evaluating the efficiency of recovery responses, retention and fall-risk reduction to slips or trips induced during normal walking in healthy older adults. Participants will be community dwelling ambulatory older adults between the age range of 60 to 90 years. Subjects will be screened for the inclusion criteria. Subjects who qualify will go through clinical balance assessment and dynamic stability training. The older adults will be divided into any of the four groups -1) overground slip only training, 2) overground trip only training, 3) overground combined slip + trip training, or 4) control (single slip + single trip). For both overground slip/trip, all subjects' normal walking pattern and their recovery responses to slip/trip will be recorded with a motion tracking system (including videotaping) while they walk across an instrumented area along a straight path in the lab. A slip will be induced after a subject steps on a low-friction platform. A trip will be induced by introducing an obstacle device while the subject is walking, which consists of a hinged aluminum plate. At 12 months post-training session, the follow-up stability test will consist only of one slip and trip induced on the training side and contralateral side. Incidence of falls and physical activity will be monitored between training and re-test sessions through falls and activity monitoring-questionnaire to describe details of the falls.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Shamali Dusane, MPT
  • Phone Number: 3123552735
  • Email: sdusan2@uic.edu

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Community ambulators who use assistive device and are able to walk independently for 8m, healthy older adults between the age group of 60 to 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.

Exclusion Criteria:

  • Subjects will be excluded if they report presence of pain, osteoporosis or any medical conditions during telephone screening (see Telephone screening form). Also subjects will be excluded if they are on osteoporosis medication, and narcotics/opioids class of drugs under the sedative medications.
  • Individuals classified as osteoporotic with heel bone density measurement with a T-score < -2 using an ultrasound device.
  • Individuals with mild cognitive impairment (Mini-mental State Exam score < 25/30)
  • 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 during 6 minute walk test.
  • Subjects with body weight more than 250lbs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Slip-only training
Overground, slip specific perturbation training only delivered in a fixed sequence. After the baseline walking trials, subjects will walk for 30-35 trials, after which training will begin consisting of a first block of 8 repeated slips (S1-S8), a block of 3 regular (non-perturbed) walking trials (W1-W3), another block of 8 slips (S9-16), a second block of 3 regular walking trials (W4-W6), and a final block of 8 slips (S17-S24) mixed with 10 regular walking trials.
Other: Slip-only training
Subjects in this arm will receive overground, slip specific perturbation training only. The total perturbation training trials received by this group will be 24 but the protocol will consist of a total of 70-75 trials (to match the training length and time of Combined slip and trip training group).
Experimental: Trip-only training
Trip specific training delivered in an identical sequence (mixed with non-trip trials) as the Group with slip only training.
Other: Trip-only training
Subjects in this arm consisting of a total of 24 trials of trip specific training delivered in an identical sequence (mixed with non-trip trials) as the Group with slip only training.
No Intervention: Control
Walk for about 70-75 trials at the preferred walking pace to match the total trials the other groups receive before the test perturbations.
Experimental: Combined slip+trip training
Training consisting of repeated exposure to both slips and trips.
Other: Combined slip+trip training
Subjects in this arm will receive training consisting of repeated exposure to both slips and trips with a total of 24 slips plus 24 trips to keep the number of trials of each perturbation same as the perturbation specific training groups (slip only and trip only), however, the total dose will be doubled. The total trials walked (perturbed + unperturbed) will be 75.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in laboratory-induced falls
Time Frame: Baseline (1st novel slip, week 1), Immediate post-training (after repeated perturation training session, week 1 ) and at 12-month re-test (to determine long-term retention of training).
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 12 months after the initial training session.
Baseline (1st novel slip, week 1), Immediate post-training (after repeated perturation training session, week 1 ) and at 12-month re-test (to determine long-term retention of training).
Real life falls
Time Frame: prospective post-training over next 12 months (total falls tracked and reported at 12 months post-training will be compared between groups)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Stability gain (or loss)
Time Frame: Baseline (1st novel slip, week 1), Immediate post-training (after repeated perturation training session, week 1) and at 12-month re-test (to determine long-term retention of training).
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), Immediate post-training (after repeated perturation training session, week 1) and at 12-month re-test (to determine long-term retention of training).
Limb support gain (or loss)
Time Frame: Baseline (1st novel slip, week 1), Immediate post-training (after repeated perturation training session, week 1) and at 12-month re-test (to determine long-term retention of training).
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), Immediate post-training (after repeated perturation training session, week 1) and at 12-month re-test (to determine long-term retention of training).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Illinois at Chicago

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tanvi Bhatt, PhD PT, University of Illinois at Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016-0887
  • 1R01AG050672-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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