Clinical trial NCT04763850: Effects of Real-time Feedback During Decline Walking on Kinematic and Kinetic Gait Parameters in a Healthy Population
Official title: Effects of Real-time Feedback During Decline Walking on Kinematic and Kinetic Gait Parameters (Up & Down)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Real-time feedback
Decline walking
Leg alignment
Kinematic
Kinetic
Treadmill
Lead sponsor: FH Campus Wien, University of Applied Sciences
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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)

Primary outcomes:
measure: frontal knee range of motion during stance phase
timeFrame: during intervention
Secondary outcomes:
measure: ground reaction force loading ratio
timeFrame: during intervention
Other outcomes:
measure: 3D kinematics of the lower limb
timeFrame: during intervention
measure: 3D kinetics of the lower limb
timeFrame: during intervention
Locations:
city: Vienna
country: Austria
facility: FH Campus Wien, University of Applied Sciences
Study officials:
References:
citation: 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.