Effect of Adaptive Training for Balance Recovery

July 14, 2021 updated by: Tanvi Bhatt, University of Illinois at Chicago

Perturbation Training for Fall-risk Reduction Among Older Adults

The long-term objective of this research is a prophylactic approach that can reduce the incidence of falls and the resulting injuries among older adults at risk and thus reduce its escalating medical cost. This project explores perturbation training through the use of treadmill device and a motor learning approach, in which experience with slip-like perturbation generated by that treadmill is used to prepare the motor system to develop and then put to use fall-resisting skills outside of training environment (cross-environment transfer). The computer-controlled treadmill is portable, safe and easy to operate, thus conducive for use in clinics or community centers. The study logically builds on and complements the team's previous and current research programs, and will further test that after such a single session, older adults at risk can retain such cross-environment transfer and reduce their likelihood of falls in everyday living for the next 6 to 12 months. Finally, the study will explore that such reduction of falls does not come merely from these persons' familiarity with the training or testing setup, protocol and environments.

Study Overview

Study Type

Interventional

Enrollment (Actual)

308

Phase

  • 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 Locations

    • Illinois
      • Chicago, Illinois, United States, 60612
        • Clinical Gait and Movement Analysis Laboratory

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

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with no known history of musculoskeletal, neurological, cardiovascular, or pulmonary impairment that may affect their ability to perform the testing procedures will be included.

Exclusion Criteria:

  • Ultrasound calcaneus bone mineral density T score < -2.5 (osteoporotic)
  • Mini-Mental State exam score < 25 (cognitive impairment)

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treadmill perturbation
treadmill slip perturbation
Group A will receive perturbation training on a treadmill with precisely controlled slip-like displacements and then encounter an unannounced novel slip during over-ground walking.
Placebo Comparator: treadmill placebo
treadmill training placebo
An age-matched control group (Group B) will receive only placebo training (on the same treadmill for the same duration but without perturbation) but encounter an identical novel slip during their over-ground walking.
Sham Comparator: observation
observation training
An age-matched observation-training group (Group C) will watch a training video and slides. When exposed to an identical novel slip in over-ground walking, they will know where and how the slip is going to occur and how to resist a fall.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fall incidence
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dynamic stability
Time Frame: 6 months
The dynamic stability will be evaluated based on the dynamic relationship of motion state (i.e., the combination of position and velocity) between the center of mass and the base of support. It will be calculated as the shortest distance from the instantaneous motion state of the center of mass to the threshold against backward fall. It is a dimensionless variable.
6 months

Collaborators and Investigators

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

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

April 25, 2014

First Submitted That Met QC Criteria

April 29, 2014

First Posted (Estimate)

April 30, 2014

Study Record Updates

Last Update Posted (Actual)

July 16, 2021

Last Update Submitted That Met QC Criteria

July 14, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2000-0788
  • R01AG044364 (U.S. NIH Grant/Contract)

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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