HealthyUp_and_DownNCT04763850
Effects of Real-time Feedback During Decline Walking on Kinematic and Kinetic Gait Parameters in a Healthy Population
A study testing Decline Walking with real-time Feedback in people with Healthy, run by Klaus Widhalm at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Decline Walking with real-time Feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 26 Jan 2021to 25 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- non-physiological and non-symmetrical gait patterns
- severe outliers (more than two standard deviations)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Decline Walking with real-time Feedback
- Keywords
- Real-time feedback, Decline walking, Leg alignment, Kinematic, Kinetic, Treadmill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decline Walking with real-time FeedbackOther
Also called Decline Walking with increased internal focus of attention, Decline Walking
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
| Study group | Role | What they receive |
|---|---|---|
| Walking decline | Experimental | Walking decline on an instrumented treadmill under 3 different conditions Receives: Other: Decline Walking with real-time Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
frontal knee range of motion during stance phase
frontal knee range of motion [degree]
Measured: during intervention
Secondary outcomes (1)
ground reaction force loading ratio
ground reaction force loading ratio [newton per second]
Measured: during intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start26 Jan 2021
- Primary completion27 Apr 2021
- Study completion25 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klaus Widhalm
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Klaus Widhalm, Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763850
- Sponsor's protocol ID
- project2010559
- Acronym
- Up_and_Down
- Status last verified
- May 2021
- First submitted
- 17 Feb 2021
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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;27(1):60. doi: 10.1186/s12891-025-09437-7.
PubMed 41430600Widhalm 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.
PubMed 34294137
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Real-time Feedback During Decline Walking on Kinematic and Kinetic Gait Parameters (Up & Down)
- ClinicalTrials.gov ID
- NCT04763850
- Acronym / sponsor ID
- Up_and_Down / project2010559
- Conditions
- Healthy
- Keywords
- Real-time feedback, Decline walking, Leg alignment, Kinematic, Kinetic, Treadmill
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Klaus WidhalmUniversity, hospital or other
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 27 Apr 2021 (actual)
- Study completion
- 25 May 2021 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Walking decline | Experimental | Other: Decline Walking with real-time FeedbackWalking decline on an instrumented treadmill under 3 different conditions |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- non-physiological and non-symmetrical gait patterns
- severe outliers (more than two standard deviations)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decline Walking with real-time FeedbackAlso: Decline Walking with increased internal focus of attention, Decline WalkingParticipants 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 | Walking decline |
Primary outcome
frontal knee range of motion during stance phase
Time frame: during intervention
frontal knee range of motion [degree]
1 secondary outcome
ground reaction force loading ratio
Time frame: during intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Derived from this study: PubMed 41430600Widhalm 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;27(1):60. doi: 10.1186/s12891-025-09437-7.
- Derived from this study: PubMed 34294137Widhalm 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.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decline Walking with real-time Feedback in people with Healthy, run by Klaus Widhalm at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frontal knee range of motion during stance phase (time frame: during intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04763850, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.