- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04763850
Effects of Real-time Feedback During Decline Walking on Kinematic and Kinetic Gait Parameters in a Healthy Population (Up_and_Down)
Effects of Real-time Feedback During Decline Walking on Kinematic and Kinetic Gait Parameters (Up & Down)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Vienna, Austria, 1100
- FH Campus Wien, University of Applied Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- non-physiological and non-symmetrical gait patterns
- severe outliers (more than two standard deviations)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Walking decline
Walking decline on an instrumented treadmill under 3 different conditions
|
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
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
frontal knee range of motion during stance phase
Time Frame: during intervention
|
frontal knee range of motion [degree]
|
during intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ground reaction force loading ratio
Time Frame: during intervention
|
ground reaction force loading ratio [newton per second]
|
during intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
3D kinematics of the lower limb
Time Frame: during intervention
|
joint angles [degree]
|
during intervention
|
|
3D kinetics of the lower limb
Time Frame: during intervention
|
external joint moments [newtonmetre per kilogram bodyweight] frontal knee moment impulses [newtonmeter per kilogram bodyweight per second]
|
during intervention
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- project2010559
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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