NCT04763850

Brief Summary

Control of the dynamic functional leg alignment (dFLA) and biomechanical load are important joint related aspects regarding the development of osteoarthritis (OA). Research on level walking with feedback on load related parameters provided innovative treatment possibilities. Concerning walking on sloped surfaces, fundamental biomechanical knowledge exists. However, deeper insights into the control of the dFLA during decline walking, and the usefulness of real-time feedback are missing. This study is set up as cross-sectional observation of gait under four conditions, which follows a randomized sequence in order to avoid carry over effects. Thirty (30) participants aged between 18 and 35 years will be included. They will complete a three-dimensional gait analysis on a 5-m ramp with 10° inclination. Afterwards they will be observed under four different conditions a) self-paced walking b) self-paced walking with internal focus of attention, c) self-paced walking with real-time feedback, and d) condition c speed-matched walking, on a 10° declined split belt treadmill. The primary outcome parameter will be the frontal knee range of motion (fKROM). Secondary outcomes include the ground reaction force loading rate, spatial-temporal parameters, sagittal frontal and transversal kinematics, and kinetics for the lower extremities. The findings should improve the understanding of effects of real-time feedback on the control of the dFLA and lower limb loading. Results will be published in a peer-review journal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable healthy

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

Study Start

First participant enrolled

January 26, 2021

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2021

Completed
Last Updated

May 26, 2021

Status Verified

May 1, 2021

Enrollment Period

3 months

First QC Date

February 17, 2021

Last Update Submit

May 25, 2021

Conditions

Keywords

Real-time feedbackDecline walkingLeg alignmentKinematicKineticTreadmill

Outcome Measures

Primary Outcomes (1)

  • frontal knee range of motion during stance phase

    frontal knee range of motion \[degree\]

    during intervention

Secondary Outcomes (1)

  • ground reaction force loading ratio

    during intervention

Other Outcomes (2)

  • 3D kinematics of the lower limb

    during intervention

  • 3D kinetics of the lower limb

    during intervention

Study Arms (1)

Walking decline

EXPERIMENTAL

Walking decline on an instrumented treadmill under 3 different conditions

Other: Decline Walking with real-time Feedback

Interventions

Participants are walking decline with self-paced speed on an instrumented treadmill with virtual reality projection under three conditions: without instruction, with instruction for an internal focus of attention and with real-time feedback of their frontal knee alignment

Also known as: Decline Walking with increased internal focus of attention, Decline Walking
Walking decline

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age from 18-35 years
  • body mass index from 18.5 to 29.99 kg/m²
  • no chronical joint diseases and/or OA surgery
  • no neuro-motor diseases

You may not qualify if:

  • non-physiological and non-symmetrical gait patterns
  • severe outliers (more than two standard deviations)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FH Campus Wien, University of Applied Sciences

Vienna, 1100, Austria

Location

Related Publications (2)

  • Widhalm K, Durstberger S, Putz P. Effects of visual real-time feedback during decline walking on gait parameters: a crossover randomized trial. BMC Musculoskelet Disord. 2025 Dec 23. doi: 10.1186/s12891-025-09437-7. Online ahead of print.

  • Widhalm K, Durstberger S, Putz P. Effects of real-time feedback during decline walking on kinematic and kinetic gait parameters in a healthy population: study protocol for a randomized trial - up and down. Trials. 2021 Jul 22;22(1):477. doi: 10.1186/s13063-021-05422-2.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: The study is set up as cross-sectional observation of gait under four conditions, which follows a randomized sequence in order to avoid carry over effects. Chronologically, the assessments will start with the tertiary observation, investigating agreements between declined/inclined ramp and treadmill walking. Thereafter, three out of four conditions (self-paced walking, self-paced walking with internal focus of attention, and self-paced walking with real-time feedback) are tested under block randomization of their six possible permutations . With three conditions (n=3), this represents the smallest number of permutations, equaling a Williams design, where each condition precedes each other condition equally often and each treatment occurs equally frequently at each position. The fourth corresponding condition (speed-matched walking) is exempted from the sequence randomization and always follows after self-paced walking with real-time feedback.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Academic Staff

Study Record Dates

First Submitted

February 17, 2021

First Posted

February 21, 2021

Study Start

January 26, 2021

Primary Completion

April 27, 2021

Study Completion

May 25, 2021

Last Updated

May 26, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

A manuscript will be submitted to a journal with peer review process aiming for an open access publication. Coded raw data will be made available upon request and for non-commercial purposes after publication of the results.

Locations