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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04763850
Recruitment Status : Completed
First Posted : February 21, 2021
Last Update Posted : May 26, 2021
Sponsor:
Information provided by (Responsible Party):
Klaus Widhalm, FH Campus Wien, University of Applied Sciences

Study Description
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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.


Condition or disease Intervention/treatment Phase
Healthy Other: Decline Walking with real-time Feedback Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Real-time Feedback During Decline Walking on Kinematic and Kinetic Gait Parameters (Up & Down)
Actual Study Start Date : January 26, 2021
Actual Primary Completion Date : April 27, 2021
Actual Study Completion Date : May 25, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Walking decline
Walking decline on an instrumented treadmill under 3 different conditions
 Other: 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
Other Names:
  • Decline Walking with increased internal focus of attention
  • Decline Walking


Outcome Measures
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Primary Outcome Measures :
  1. frontal knee range of motion during stance phase [ Time Frame: during intervention ]
    frontal knee range of motion [degree]


Secondary Outcome Measures :
  1. ground reaction force loading ratio [ Time Frame: during intervention ]
    ground reaction force loading ratio [newton per second]


Other Outcome Measures:
  1. 3D kinematics of the lower limb [ Time Frame: during intervention ]
    joint angles [degree]

  2. 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]


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04763850


Locations
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Austria
FH Campus Wien, University of Applied Sciences
Vienna, Austria, 1100
Sponsors and Collaborators
Klaus Widhalm
  Study Documents (Full-Text)

Documents provided by Klaus Widhalm, FH Campus Wien, University of Applied Sciences:
Study Protocol and Statistical Analysis Plan  [PDF] December 17, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Klaus Widhalm, Academic Staff, FH Campus Wien, University of Applied Sciences
ClinicalTrials.gov Identifier: NCT04763850    
Other Study ID Numbers: project2010559
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: May 26, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Klaus Widhalm, FH Campus Wien, University of Applied Sciences:
Real-time feedback
Decline walking
Leg alignment
 Kinematic
Kinetic
Treadmill