Clinical trial NCT06516120: Kinematics of Movements Provoked by an Augmented Reality App
Official title: Kinematics of Upper Limb Movements Provoked by an Augmented Reality App in Comparison to Therapy Exercises.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Healthy Aging
Keywords: Home-based rehabilitation
Augmented reality
Upper limb
Lead sponsor: Sint Maartenskliniek
Sponsor class: OTHER
Collaborators: name: Eodyne Systems SL
First posted: 2024-07-23
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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).


Eligibility criteria: 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 (Montreal Cognitive Assessment \< 19)
* 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

Primary outcomes:
measure: Average movement velocity
timeFrame: Measured when using the RGS-app during the one-time measurement of 1.5 hours
Secondary outcomes:
measure: Elbow mean angular velocity
timeFrame: Measured when using the RGS-app during the one-time measurement of 1.5 hours
measure: Pelvis mean angular velocity
timeFrame: Measured when using the RGS-app during the one-time measurement of 1.5 hours
measure: Elbow Range of motion
timeFrame: Measured when using the RGS-app during the one-time measurement of 1.5 hours
measure: Pelvis range of motion
timeFrame: Measured when using the RGS-app during the one-time measurement of 1.5 hours
Other outcomes:
Locations:
city: Ubbergen
country: Netherlands
facility: Sint Maartenskliniek
state: Gelderland
Study officials:
affiliation: Donders Institute for Brain, Cognition and Behavior, Radboud University
name: Noël Keijsers, Prof.
role: PRINCIPAL_INVESTIGATOR
References: