Kinematics of Movements Provoked by an Augmented Reality App

NCT06516120 | Recruiting

• 1 other identifier: 1103
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

Stroke; Healthy Aging

Keywords

Home-based rehabilitation; Augmented reality; Upper limb

Outcome Measures

Primary Outcomes (1)

• Average movement velocity

  Average velocity of every 2-minute session. Velocity is measured at the hand relative to the sternum.

  Measured when using the RGS-app during the one-time measurement of 1.5 hours

Secondary Outcomes (4)

• Elbow mean angular velocity

  Measured when using the RGS-app during the one-time measurement of 1.5 hours

• Pelvis mean angular velocity

  Measured when using the RGS-app during the one-time measurement of 1.5 hours

• Elbow Range of motion

  Measured when using the RGS-app during the one-time measurement of 1.5 hours

• Pelvis range of motion

  Measured when using the RGS-app during the one-time measurement of 1.5 hours

Study Arms (2)

Healthy elderly

Group of participants who have no prior history of stroke

Behavioral: RGS-app

Stroke survivor

Group of participants who have been through a stroke

Behavioral: RGS-app

Interventions

RGS-app 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.

Healthy elderly; Stroke survivor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• Severe cognitive impairment (Montreal Cognitive Assessment \< 19)
• Visual impairments (which cannot be corrected with glasses)
• Upper limb impairments not caused by the stroke
• years or older
• Smartphone users
• Visual impairments (which cannot be corrected with glasses)
• Upper limb impairments which can affect smartphone use

Sponsors & Collaborators

• Sint Maartenskliniek: lead
• Eodyne Systems SL: collaborator

Study Sites (1)

Sint Maartenskliniek

Ubbergen, Gelderland, 6574 NA, Netherlands

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Noël Keijsers, Prof.

  Donders Institute for Brain, Cognition and Behavior, Radboud University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Merle Matijsen, MSc

CONTACT

m.matijsen@maartenskliniek.nl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: July 23, 2024
• Study Start: May 13, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)