- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06516120
Kinematics of Movements Provoked by an Augmented Reality App
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).
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Gelderland
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Ubbergen, Gelderland, Netherlands, 6574 NA
- Sint Maartenskliniek
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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.
Description
Inclusion Criteria stroke survivors:
- 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)
Exclusion Criteria stroke survivors:
- Severe cognitive impairment
- Visual impairments (which cannot be corrected with glasses)
- Upper limb impairments not caused by the stroke
Inclusion Criteria healthy elderly:
- 60 years or older
- Smartphone users
Exclusion Criteria healthy elderly:
- Visual impairments (which cannot be corrected with glasses)
- Upper limb impairments which can affect smartphone use
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Healthy elderly
Group of participants who have no prior history of stroke
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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.
|
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Stroke survivor
Group of participants who have been through a stroke
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average movement velocity
Time Frame: Measured when using the RGS-app during the one-time measurement of 1.5 hours
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Average velocity of every 2-minute session.
Velocity is measured at the hand relative to the sternum.
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Measured when using the RGS-app during the one-time measurement of 1.5 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Elbow Range of motion
Time Frame: Measured when using the RGS-app during the one-time measurement of 1.5 hours
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Range of motion in degrees of the elbow joint (0 degrees being fully stretched)
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Measured when using the RGS-app during the one-time measurement of 1.5 hours
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Pelvis range of motion
Time Frame: Measured when using the RGS-app during the one-time measurement of 1.5 hours
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Range of motion in degrees of the elbow joint (0 degrees meaning vertical)
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Measured when using the RGS-app during the one-time measurement of 1.5 hours
|
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Peak velocity
Time Frame: Measured when using the RGS-app during the one-time measurement of 1.5 hours
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The maximum velocity measured at the hand
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Measured when using the RGS-app during the one-time measurement of 1.5 hours
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Hand distance
Time Frame: Measured when using the RGS-app during the one-time measurement of 1.5 hours
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Distance covered by the hand corrected by the sternum movements
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Measured when using the RGS-app during the one-time measurement of 1.5 hours
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Noël Keijsers, Prof., Donders Institute for Brain, Cognition and Behavior, Radboud University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1103
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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