Aging and Mixed Perturbation Training to Reduce Falls in Locomotion

NCT03199729 | Active Not Recruiting

• 2 other identifiers: 2016-08871R01AG050672-01A1
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Older Adults

Keywords

Overground training; Dynamic Stability; Fall risk

Outcome Measures

Primary Outcomes (2)

• 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 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

  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 Outcomes (2)

• Stability gain (or loss)

  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)

  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).

Study Arms (4)

Slip-only training

EXPERIMENTAL

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

Trip-only training

EXPERIMENTAL

Trip specific training delivered in an identical sequence (mixed with non-trip trials) as the Group with slip only training.

Other: Trip-only training

Control

NO INTERVENTION

Walk for about 70-75 trials at the preferred walking pace to match the total trials the other groups receive before the test perturbations.

Combined slip+trip training

EXPERIMENTAL

Training consisting of repeated exposure to both slips and trips.

Other: Combined slip+trip training

Interventions

Slip-only training OTHER

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).

Slip-only training

Trip-only training OTHER

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.

Trip-only training

Combined slip+trip training OTHER

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.

Combined slip+trip training

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• Bhatt T, Wang Y, Wang S, Kannan L. Perturbation Training for Fall-Risk Reduction in Healthy Older Adults: Interference and Generalization to Opposing Novel Perturbations Post Intervention. Front Sports Act Living. 2021 Aug 16;3:697169. doi: 10.3389/fspor.2021.697169. eCollection 2021.

  PMID: 34490424 DERIVED

Study Officials

• Tanvi Bhatt, PhD PT

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Controlled design to understand the mechanisms of adaptive interference and generalization, their interaction with retention, and how these can be applied to maximize training effects for minimizing falls-risk among older adults.

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 27, 2017
• Study Start: August 1, 2017
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)