Effects of Real-time Feedback During Decline Walking on Kinematic and Kinetic Gait Parameters in a Healthy Population

NCT ID: NCT04763850

Last Updated: 2021-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-26

Study Completion Date

2021-05-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Walking decline

Walking decline on an instrumented treadmill under 3 different conditions

Group Type EXPERIMENTAL

Decline Walking with real-time Feedback

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Decline Walking with real-time Feedback

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Decline Walking with increased internal focus of attention Decline Walking

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

1. non-physiological and non-symmetrical gait patterns
2. severe outliers (more than two standard deviations)
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Klaus Widhalm

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Klaus Widhalm

Academic Staff

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

FH Campus Wien, University of Applied Sciences

Vienna, , Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34294137 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

project2010559

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.