NCT05736666

Brief Summary

The goal of this clinical trial is to learn about preventing falls in people who have total knee replacement surgery using treadmill perturbation training. Perturbation training involves adjusting to rapid speed changes on a treadmill. The main questions it aims to answer are:

  • Does perturbation training improve the way that people who are planning to have total knee replacement surgery recover after treadmill test that reproduces a trip to the front or side?
  • Does perturbation training reduce the incidence of preventable gait-related falls during the first year after total knee replacement? Participants will:
  • complete surveys about their condition and fall history and take part in testing of walking ability and balance.
  • have a baseline gait analysis test to measure the motion of their body during normal walking.
  • Be randomized into two groups. One will receive fall-prevention literature. The other will receive the same literature and then take part in a two-week treadmill perturbation training program.
  • be contacted every two weeks for one year, and asked questions about whether they have fallen during that time.
  • wear a Fitbit activity monitor on their wrist for one year. Researchers will compare the number of falls from the group that only received literature to the treatment group to see if the training group has fewer falls during the year after surgery.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
terminated

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

February 10, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
2.4 years until next milestone

Study Start

First participant enrolled

July 31, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

9 months

First QC Date

February 10, 2023

Last Update Submit

June 4, 2026

Conditions

Knee OsteoarthritisArthroplasty Complications

Keywords

FallsKnee Replacement

Outcome Measures

Primary Outcomes (3)

  • Post-training trunk angle

    post-training trunk angle at recovery step completion

    Immediately after completion of training program

  • Post-training trunk angular velocity

    post-training trunk angular at recovery step completion

    Immediately after completion of training program

  • Fall rate

    Number of falls during the first year after surgery

    1 year

Secondary Outcomes (1)

  • Fall status

    Immediately after completion of training program

Study Arms (2)

Training Group

EXPERIMENTAL

The intervention consists of disturbances delivered on a treadmill that simulates tripping over an obstacle or being perturbed to the side.

Behavioral: Treadmill-based perturbation training

Education Group

ACTIVE COMPARATOR

This group will receive educational materials related to fall prevention in older adults.

Behavioral: Education Control

Interventions

Treadmill-based perturbation trainingBEHAVIORAL

The intervention consists of disturbances delivered on a treadmill that simulates tripping over an obstacle or being perturbed to the side. These disturbances require a compensatory step to respond. Through this task-specific training, participants should learn to control their trunk motion in a way that will cause them to avoid a trip or fall to the side.

Training Group
Education ControlBEHAVIORAL

Fall prevention educational material

Education Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of endstage knee osteoarthritis requiring total knee arthroplasty (TKA). TKA scheduled within two months and able to schedule the required training visits prior to surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biomechanics and Clinical Outcomes Laboratory, University of Illinois Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Kharma Foucher, MD, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 10, 2023

First Posted

February 21, 2023

Study Start

July 31, 2025

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

June 8, 2026

Record last verified: 2026-06

Locations

US(1)