Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06590987
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-02-05
Brief Title:
Cueing-assisted Personalised Augmented-Reality Exergaming for Parkinsons Rehabilitation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Project CAPARE Cueing-assisted Personalised Augmented-Reality Exergaming for Parkinsons Rehabilitation
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPARE
Brief Summary:
The goal of this clinical feasibility study is to examine the clinical feasibility of home-based gamified cueing-assisted personalized AR gait-and-balance exercises with Reality DTx in terms of safety efficacy and patient experience in people with Parkinsons disease
Participants will undergo a 8-week RealityDTx interventionThe intended use of the Reality DTx software is to provide visual and auditory cues to assist walking and modify gait and to provide gamified AR exercise programs to improve gait and balance in PD
The main study parameters of this study to evaluate clinical feasibility of home-based gamified cueing-assisted personalized AR gait-and-balance exercises with Reality DTx are safety eg adverse events side effects patient experience eg perceived effectiveness through Likert scale reporting and the effectiveness of Reality DTx gamified AR gait-and-balance exercise program on gait and balance outcome measures
Participants will undergo a 8-week RealityDTx interventionThe intended use of the Reality DTx software is to provide visual and auditory cues to assist walking and modify gait and to provide gamified AR exercise programs to improve gait and balance in PD
The main study parameters of this study to evaluate clinical feasibility of home-based gamified cueing-assisted personalized AR gait-and-balance exercises with Reality DTx are safety eg adverse events side effects patient experience eg perceived effectiveness through Likert scale reporting and the effectiveness of Reality DTx gamified AR gait-and-balance exercise program on gait and balance outcome measures
Detailed Description:
Rationale Reality DTx is a new product with two core modules -movement assistance and movement training- that applies the existing proven principles of sensory cueing and home-based exercise for people with Parkinsons disease PD onto augmented-reality AR headsets
Objective The primary objective of this study in people with PD is to examine the clinical feasibility in terms of safety adherence performance and user experience ie patient and physiotherapist and effectiveness of home-based gamified cueing-assisted personalized AR gait-and-balance exercises with Reality DTx
Study design This clinical feasibility study is a concealed two-arm Randomized Controlled Trial and consists of three in-clinic assessments After a baseline assessment of standard clinical tests participants will start with a 6-week usual care control period After 6 weeks participants undergo the midterm assessments Then participants will start with the 8-week Reality DTx intervention ie 2 weeks of practice in clinic and 6 weeks of training at home and will receive a final assessment hereafter A predefined two-armed block-randomisation will determine which participants will be allocated to the control group and which participants will be allocated to the intervention group
Study population People with PD who experience bothersome gait andor balance problems as indicated by the participant will participate in the clinical feasibility study n100
Intervention Reality DTx a class I CE marked medical device is a software application for AR headsets such as HoloLens 2 and Magic Leap 2 The intended use of the Reality DTx software is to provide visual and auditory cues to assist walking and modify gait and to provide gamified AR exercise programs to improve gait and balance in PD
Main study parametersendpoints The main study parameters of the clinical feasibility study to evaluate home-based gamified cueing-assisted personalized AR gait-and-balance exercises with Reality DTx are feasibility in terms of safety adherence performance and user experience and effectiveness in terms of gait-and-balance outcome measures of standard clinical tests
Nature and extent of the burden and risks associated with participation benefit and group relatedness The risks of this study are minimal and the burden on the participants is low to medium considering the clinical assessments and daily exercise and likely outweighs the benefits associated with physical activity promotion in people with PD in general such as slowing down the progression of motor symptoms and boosting their gait-and-balance skills through the offered home-based gamified AR exercises program as an addition to usual care
Objective The primary objective of this study in people with PD is to examine the clinical feasibility in terms of safety adherence performance and user experience ie patient and physiotherapist and effectiveness of home-based gamified cueing-assisted personalized AR gait-and-balance exercises with Reality DTx
Study design This clinical feasibility study is a concealed two-arm Randomized Controlled Trial and consists of three in-clinic assessments After a baseline assessment of standard clinical tests participants will start with a 6-week usual care control period After 6 weeks participants undergo the midterm assessments Then participants will start with the 8-week Reality DTx intervention ie 2 weeks of practice in clinic and 6 weeks of training at home and will receive a final assessment hereafter A predefined two-armed block-randomisation will determine which participants will be allocated to the control group and which participants will be allocated to the intervention group
Study population People with PD who experience bothersome gait andor balance problems as indicated by the participant will participate in the clinical feasibility study n100
Intervention Reality DTx a class I CE marked medical device is a software application for AR headsets such as HoloLens 2 and Magic Leap 2 The intended use of the Reality DTx software is to provide visual and auditory cues to assist walking and modify gait and to provide gamified AR exercise programs to improve gait and balance in PD
Main study parametersendpoints The main study parameters of the clinical feasibility study to evaluate home-based gamified cueing-assisted personalized AR gait-and-balance exercises with Reality DTx are feasibility in terms of safety adherence performance and user experience and effectiveness in terms of gait-and-balance outcome measures of standard clinical tests
Nature and extent of the burden and risks associated with participation benefit and group relatedness The risks of this study are minimal and the burden on the participants is low to medium considering the clinical assessments and daily exercise and likely outweighs the benefits associated with physical activity promotion in people with PD in general such as slowing down the progression of motor symptoms and boosting their gait-and-balance skills through the offered home-based gamified AR exercises program as an addition to usual care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None