Kinematics of Movements Provoked by an Augmented Reality App

NCT ID: NCT06516120

Last Updated: 2024-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-13

Study Completion Date

2024-12-01

Brief Summary

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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).

Detailed Description

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Conditions

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Stroke Healthy Aging

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy elderly

Group of participants who have no prior history of stroke

RGS-app

Intervention Type BEHAVIORAL

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.

Stroke survivor

Group of participants who have been through a stroke

RGS-app

Intervention Type BEHAVIORAL

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.

Interventions

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RGS-app

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Severe cognitive impairment (Montreal Cognitive Assessment \< 19)
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eodyne Systems SL

INDUSTRY

Sponsor Role collaborator

Sint Maartenskliniek

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Noël Keijsers, Prof.

Role: PRINCIPAL_INVESTIGATOR

Donders Institute for Brain, Cognition and Behavior, Radboud University

Locations

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Sint Maartenskliniek

Ubbergen, Gelderland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Merle Matijsen, MSc

Role: CONTACT

Other Identifiers

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1103

Identifier Type: -

Identifier Source: org_study_id

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