StrokeNCT06516120
Kinematics of Movements Provoked by an Augmented Reality App
An observational study of Stroke and Healthy Aging, run by Sint Maartenskliniek at 1 site in Netherlands.
Trial summary
Introduction: Home-based rehabilitation has the potential to reduce healthcare costs. However, due to less supervision in the home situation, it is possible that movements are made incorrectly. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Healthy Aging
- What is being tested?
- RGS-app
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 28 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 May 2023to 1 Oct 2025
- Phase
- Observational
- 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
Study population: Stroke survivors will be recruited through a Rehabilitation physician at the Sint Maartenskliniek and if needed through social media. Healthy elderly will be recruited using social media.
Who may be able to join
- People who suffered from a stroke at least 2 months ago.
- Smartphone users
- Mild to moderate upper limb impairment (Medical Research Council Scale for Muscle Strength (MRC) ≥ 2)
- 60 years or older
- Smartphone users
Who cannot join
- Severe cognitive impairment
- Visual impairments (which cannot be corrected with glasses)
- Upper limb impairments not caused by the stroke
- Visual impairments (which cannot be corrected with glasses)
- Upper limb impairments which can affect smartphone use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kinematics of Upper Limb Movements Provoked by an Augmented Reality App in Comparison to Therapy Exercises.
Introduction: Home-based rehabilitation has the potential to reduce healthcare costs. However, due to less supervision in the home situation, it is possible that movements are made incorrectly. Therefore it is important to gain insight in which movements are made with a home-based rehabilitation system and what effects instructions could have on these movements. The current study investigated these movements made by the Rehabilitation Gaming System (RGS) app, this app uses augmented reality to provoke upper limb movements.
Methods: 16 healthy elderly and 16 stroke survivors participate in this study. Each participant was invited to the rehabilitation clinic for a one time measurement of 1.5 hours. During this measurement, four therapy exercises and four games on the RGS-app are performed. Each game should provoke a similar movement as one of the therapy exercises. Participants start with performing the therapy exercises for two minutes each. Thereafter they receive a video instruction on how to perform one of the games of the RGS-app, and they will play this game for 2 minutes. Thereafter the group is randomized into two conditions. The first group receives the same video instruction, while the second group receives a personalized live instruction based on the first two minutes of playing. After the new instruction, participants will play the game for two minutes again. This is repeated for all four games. Both the order of the therapy exercises and RGS-app games are randomized. During the study, participants wear Inertial Measurement Units (IMU's).
- Conditions
- Stroke, Healthy Aging
- Being tested
- RGS-app
- Keywords
- Home-based rehabilitation, Augmented reality, Upper limb
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RGS-appBehavioural
Participants use the RGS-app on a smartwatch once for 1.5 hours during the measurement. The RGS-app consists of augmented reality games to provoke upper limb movement.
| Study group | Role | What they receive |
|---|---|---|
| Healthy elderly | Group of participants who have no prior history of stroke Receives: Behavioral: RGS-app | |
| Stroke survivor | Group of participants who have been through a stroke Receives: Behavioral: RGS-app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average movement velocity
Average velocity of every 2-minute session. Velocity is measured at the hand relative to the sternum.
Measured: Measured when using the RGS-app during the one-time measurement of 1.5 hours
Secondary outcomes (4)
Peak velocity
The maximum velocity measured at the hand
Measured: Measured when using the RGS-app during the one-time measurement of 1.5 hours
Hand distance
Distance covered by the hand corrected by the sternum movements
Measured: Measured when using the RGS-app during the one-time measurement of 1.5 hours
Elbow Range of motion
Range of motion in degrees of the elbow joint (0 degrees being fully stretched)
Measured: Measured when using the RGS-app during the one-time measurement of 1.5 hours
Pelvis range of motion
Range of motion in degrees of the elbow joint (0 degrees meaning vertical)
Measured: Measured when using the RGS-app during the one-time measurement of 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start13 May 2023
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sint Maartenskliniek
- Sponsor type
- University, hospital or other
- Collaborators
- Eodyne Systems SL
- Responsible party
- Sponsor
- Investigators
- Noël Keijsers, Prof., Principal investigator, Donders Institute for Brain, Cognition and Behavior, Radboud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516120
- Sponsor's protocol ID
- 1103
- Status last verified
- Aug 2025
- First submitted
- 6 Mar 2024
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinematics of Upper Limb Movements Provoked by an Augmented Reality App in Comparison to Therapy Exercises.
- ClinicalTrials.gov ID
- NCT06516120
- Acronym / sponsor ID
- 1103
- Conditions
- Stroke, Healthy Aging
- Keywords
- Home-based rehabilitation, Augmented reality, Upper limb
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Sint MaartenskliniekUniversity, hospital or other
- Collaborators
- Eodyne Systems SL
- Study start
- 13 May 2023 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 23 Jul 2024 (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.
Introduction: Home-based rehabilitation has the potential to reduce healthcare costs. However, due to less supervision in the home situation, it is possible that movements are made incorrectly. Therefore it is important to gain insight in which movements are made with a home-based rehabilitation system and what effects instructions could have on these movements. The current study investigated these movements made by the Rehabilitation Gaming System (RGS) app, this app uses augmented reality to provoke upper limb movements.
Methods: 16 healthy elderly and 16 stroke survivors participate in this study. Each participant was invited to the rehabilitation clinic for a one time measurement of 1.5 hours. During this measurement, four therapy exercises and four games on the RGS-app are performed. Each game should provoke a similar movement as one of the therapy exercises. Participants start with performing the therapy exercises for two minutes each. Thereafter they receive a video instruction on how to perform one of the games of the RGS-app, and they will play this game for 2 minutes. Thereafter the group is randomized into two conditions. The first group receives the same video instruction, while the second group receives a personalized live instruction based on the first two minutes of playing. After the new instruction, participants will play the game for two minutes again. This is repeated for all four games. Both the order of the therapy exercises and RGS-app games are randomized. During the study, participants wear Inertial Measurement Units (IMU's).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy elderly | – | Behavioral: RGS-appGroup of participants who have no prior history of stroke |
| Stroke survivor | – | Behavioral: RGS-appGroup of participants who have been through a stroke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke survivors will be recruited through a Rehabilitation physician at the Sint Maartenskliniek and if needed through social media. Healthy elderly will be recruited using social media.
Key inclusion criteria (5 listed)
- People who suffered from a stroke at least 2 months ago.
- Smartphone users
- Mild to moderate upper limb impairment (Medical Research Council Scale for Muscle Strength (MRC) ≥ 2)
- 60 years or older
- Smartphone users
Key exclusion criteria (5 listed)
- Severe cognitive impairment
- Visual impairments (which cannot be corrected with glasses)
- Upper limb impairments not caused by the stroke
- Visual impairments (which cannot be corrected with glasses)
- Upper limb impairments which can affect smartphone use
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 |
|---|---|---|
| RGS-appParticipants use the RGS-app on a smartwatch once for 1.5 hours during the measurement. The RGS-app consists of augmented reality games to provoke upper limb movement. | Behavioural | Healthy elderly, Stroke survivor |
Primary outcome
Average movement velocity
Time frame: Measured when using the RGS-app during the one-time measurement of 1.5 hours
Average velocity of every 2-minute session. Velocity is measured at the hand relative to the sternum.
4 secondary outcomes
Peak velocity
Time frame: Measured when using the RGS-app during the one-time measurement of 1.5 hours
Hand distance
Time frame: Measured when using the RGS-app during the one-time measurement of 1.5 hours
Elbow Range of motion
Time frame: Measured when using the RGS-app during the one-time measurement of 1.5 hours
Pelvis range of motion
Time frame: Measured when using the RGS-app during the one-time measurement of 1.5 hours
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 7 May 2026.
- 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.
Noël Keijsers, Prof. principal investigator
Donders Institute for Brain, Cognition and Behavior, Radboud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Healthy Aging, run by Sint Maartenskliniek 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 5 inclusion and 5 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 7 May 2026. 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.
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?
Average movement velocity (time frame: Measured when using the RGS-app during the one-time measurement of 1.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2026.