NCT02126488

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
308

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 30, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

8.5 years

First QC Date

April 25, 2014

Last Update Submit

May 14, 2024

Conditions

Keywords

treadmill traininggeneralizationretention

Outcome Measures

Primary Outcomes (1)

  • Fall incidence

    1 year

Secondary Outcomes (1)

  • Dynamic stability

    6 months

Study Arms (3)

treadmill perturbation

EXPERIMENTAL

treadmill slip perturbation

Behavioral: treadmill slip perturbation

treadmill placebo

PLACEBO COMPARATOR

treadmill training placebo

Behavioral: treadmill training placebo

observation

SHAM COMPARATOR

observation training

Behavioral: observation training

Interventions

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.

treadmill perturbation

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.

treadmill placebo

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.

observation

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Gait and Movement Analysis Laboratory

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

  • Wang Y, Wang S, Liu X, Lee A, Pai YC, Bhatt T. Can a single session of treadmill-based slip training reduce daily life falls in community-dwelling older adults? A randomized controlled trial. Aging Clin Exp Res. 2022 Jul;34(7):1593-1602. doi: 10.1007/s40520-022-02090-3. Epub 2022 Mar 2.

Study Officials

  • Tanvi Bhatt, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 25, 2014

First Posted

April 30, 2014

Study Start

June 1, 2014

Primary Completion

December 15, 2022

Study Completion

December 15, 2022

Last Updated

May 16, 2024

Record last verified: 2024-05

Locations