Proprioception KneeEarly Phase 1NCT07141290
Motor Control Exergame
A Early Phase 1 study testing Silent fish and bunny game and Sound supported fish and bunny game in people with Proprioception Knee and Healthy Volunteers, run by University of Groningen at 1 site in Netherlands.
Trial summary
This study investigates whether auditory feedback improves the performance of people training squats or kicking movement with a computer game that gives feedback on the user's performance. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Proprioception Knee, Healthy Volunteers
- What is being tested?
- Silent fish and bunny game and Sound supported fish and bunny game
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Apr 2025to 11 Apr 2025
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- Healthy based on self-report
Who cannot join
- Pregnancy based on self-report
- Orthopedic problems, musculoskeletal disorder, or prior surgery on the lower extremities based on self-report
- Abuse of drugs, growth hormones, anabolic steroids, or performance enhancing substances based on self-report
- Participants with a known plaster or metal allergy based on self-report
- Not being able to follow the instructions given in Dutch or English
- Not willing to wear shorts/ expose the skin of the legs for any reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Motor Control Enhancement Based on Augmented Feedback Exergame
This study investigates whether auditory feedback improves the performance of people training squats or kicking movement with a computer game that gives feedback on the user's performance.
During the study participants are wearing sensors that record the movement of their upper and lower leg and the muscle activity of the muscles used to perform squatting and kicking. At the beginning of the measurement participants will be asked to perform 10 squats, 10 half squats, and to hold some positions for a short period. Then participants will be allocated to group 1 or group 2 by a draw.
Read more
Group 1: plays the exergame without sound Group 2: plays the exergame with sound
Participants play four rounds of a squatting and four rounds of a kicking game. After playing the game they are again asked to perform 10 squats, 10 half squats, and to hold some positions for a short period. Furthermore, they fill a questionnaire in which they indicate whether they liked the game.
The researchers use the measurements taken prior and after the game to see whether participants improved in kicking and squatting. Furthermore they compare which group scores better in the game to see whether auditory feedback helps to understand the game story.
- Conditions
- Proprioception Knee, Healthy Volunteers
- Being tested
- Silent fish and bunny game, Sound supported fish and bunny game
- Keywords
- Home-based exergame, auditory feedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silent fish and bunny gameDevice
Participants play two levels of a computer game. In one level they need to squat at different levels to make a bunny jump and catch some carrots. In the other level they need to catch fiches by adjusting the extension of their leg.
Sound supported fish and bunny gameDevice
In the auditory feedback group sound is used to transfer the Knowledge of Results. The sound is linked to the joint position.
| Study group | Role | What they receive |
|---|---|---|
| Auditory feedback group | Experimental | Participants play the game with auditory feedback Receives: Device: Sound supported fish and bunny game |
| Control group | Active comparator | Participants play the game without auditory feedback Receives: Device: Silent fish and bunny game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee angle error
The knee angle is defined as the angle between the calibrated coordinate system of the mid-shank and that of the BF of the non-dominant leg measured by means of inertial measurement units. This value is compared to the desired knee angle.
Measured: Baseline and Day1
Secondary outcomes (4)
User experience questionnaire (UEQ)
User experience is assessed with the standardized user experience questionnaire (UEQ). The UEQ is a stnadardized 26 item questionnaire which assesses the dimensions Attractiveness, Perspicuity, Efficiency, Dependability, Stimulation and Novelty. For each question the participant answers on a 7 point Likert scale. The maximum number of points is 128. The minimum number of points is 26.
Measured: Day 1
Muscle activity and coordination
Electromyography data was accumulated from the major muscles in the leg. These were analyzed using NMF to see whether activation patterns are different depending on the presence of auditory feedback.
Measured: baseline and Day1
Motivation
Motivation of the participants during game play is assessed with the standardized Intrinsic Motivation Inventory (IMI) questionnaire. The version that is used within this study has 22 questions. The questions are answered on 7 point likert scales. The minimum score is 22. The maximum score is 154.
Measured: Day1
In game performance
In game performance is measured by comparing scores participants get in the game.
Measured: baseline and Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start4 Apr 2025
- Primary completion11 Apr 2025
- Study completion11 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Proprioception KneeStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141290
- Sponsor's protocol ID
- Motor_control_exergame
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang Y, Garcia Arias LF, Timmerman H, Cao M, Wilhelm E. Enhancing Knee Joint Proprioception in Healthy Adults Through Exergame Training With Augmented Feedback: Randomized Controlled Pilot Trial. JMIR Rehabil Assist Technol. 2026 Feb 26;13:e78525. doi: 10.2196/78525.
PubMed 41747255
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Control Enhancement Based on Augmented Feedback Exergame
- ClinicalTrials.gov ID
- NCT07141290
- Acronym / sponsor ID
- Motor_control_exergame
- Conditions
- Proprioception Knee, Healthy Volunteers
- Keywords
- Home-based exergame, auditory feedback
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of GroningenUniversity, hospital or other
- Study start
- 4 Apr 2025 (actual)
- Primary completion
- 11 Apr 2025 (actual)
- Study completion
- 11 Apr 2025 (actual)
- First posted
- 26 Aug 2025 (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.
This study investigates whether auditory feedback improves the performance of people training squats or kicking movement with a computer game that gives feedback on the user's performance.
During the study participants are wearing sensors that record the movement of their upper and lower leg and the muscle activity of the muscles used to perform squatting and kicking. At the beginning of the measurement participants will be asked to perform 10 squats, 10 half squats, and to hold some positions for a short period. Then participants will be allocated to group 1 or group 2 by a draw.
Group 1: plays the exergame without sound Group 2: plays the exergame with sound
Participants play four rounds of a squatting and four rounds of a kicking game. After playing the game they are again asked to perform 10 squats, 10 half squats, and to hold some positions for a short period. Furthermore, they fill a questionnaire in which they indicate whether they liked the game.
The researchers use the measurements taken prior and after the game to see whether participants improved in kicking and squatting. Furthermore they compare which group scores better in the game to see whether auditory feedback helps to understand the game story.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auditory feedback group | Experimental | Device: Sound supported fish and bunny gameParticipants play the game with auditory feedback |
| Control group | Active comparator | Device: Silent fish and bunny gameParticipants play the game without auditory feedback |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older
- Healthy based on self-report
Key exclusion criteria (6 listed)
- Pregnancy based on self-report
- Orthopedic problems, musculoskeletal disorder, or prior surgery on the lower extremities based on self-report
- Abuse of drugs, growth hormones, anabolic steroids, or performance enhancing substances based on self-report
- Participants with a known plaster or metal allergy based on self-report
- Not being able to follow the instructions given in Dutch or English
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 |
|---|---|---|
| Silent fish and bunny gameParticipants play two levels of a computer game. In one level they need to squat at different levels to make a bunny jump and catch some carrots. In the other level they need to catch fiches by adjusting the extension of their leg. | Device | Control group |
| Sound supported fish and bunny gameIn the auditory feedback group sound is used to transfer the Knowledge of Results. The sound is linked to the joint position. | Device | Auditory feedback group |
Primary outcome
Knee angle error
Time frame: Baseline and Day1
The knee angle is defined as the angle between the calibrated coordinate system of the mid-shank and that of the BF of the non-dominant leg measured by means of inertial measurement units. This value is compared to the desired knee angle.
4 secondary outcomes
User experience questionnaire (UEQ)
Time frame: Day 1
Muscle activity and coordination
Time frame: baseline and Day1
Motivation
Time frame: Day1
In game performance
Time frame: baseline and Day 1
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 Aug 2025.
- Derived from this study: PubMed 41747255Zhang Y, Garcia Arias LF, Timmerman H, Cao M, Wilhelm E. Enhancing Knee Joint Proprioception in Healthy Adults Through Exergame Training With Augmented Feedback: Randomized Controlled Pilot Trial. JMIR Rehabil Assist Technol. 2026 Feb 26;13:e78525. doi: 10.2196/78525.
- Individual participant dataSharing planned: No
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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 Early Phase 1 study testing Silent fish and bunny game and Sound supported fish and bunny game in people with Proprioception Knee and Healthy Volunteers, run by University of Groningen at 1 site in Netherlands.
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 2 inclusion and 6 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 Aug 2025. 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 Netherlands. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Knee angle error (time frame: Baseline and Day1). 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 NCT07141290, which also lists 1 linked publication.
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 Aug 2025.