Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373341
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-03-11
Brief Title:
Hand and Arm Rehabilitation Using VR
Sponsor:
Medical Centre Leeuwarden
Organization:
Medical Centre Leeuwarden
Study Overview
Official Title:
Rehabilitation of HAND and Arm Function Using a Meta QUEST-based Virtual Reality Game in ICU Patients
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HANDQUEST
Brief Summary:
Patients admitted to the ICU due to critical illness often experience physical mental cognitive or social issues Research indicates that inadequate physical recovery is associated with lower handgrip strength and hand function in ICU patients is lower compared to healthy individuals To address this a Virtual Reality VR exergame was developed to aid rehabilitation This study aims to investigate the effect of a 4-week VR-exergame intervention on handgrip strength hand and arm functionality balance mobility and support needs in ICU patients staying for 48 hours or longer It is a multicenter mixed-methods randomized controlled trial involving adult ICU patients The intervention involves a 4-week VR-exergame program Main study parameters include handgrip strength hand and arm functionality range of motion balance mobility and support needs The burden and risks associated with participation are minimal as VR-based exercises are deemed safe and voluntary Overall the study aims to assess the effect of incorporating VR-based rehabilitation into standard care for ICU patients
Detailed Description:
Rationale Patients admitted to the Intensive Care Unit ICU due to critical illness may experience new or increased physical mental cognitive or social problems Research from the MCL showed that patients with inadequate physical recovery after one year also have lower handgrip strength at discharge from the ICU and after three months In addition a recent study indicated that hand function after ICU admission is lower than in a healthy control group Early mobilisation focussing on regain of function is therefore essential in ICU patients Previously the MCL and 8D Games developed a Virtual Reality exergame that is safe and feasible to use as an addition to standard care mobilisation in the ICU ward Although the primary goal of the VR-exergame is to provide personalised and fun options in rehabilitation it may also have additional benefits when it comes to recovery after critical illness In addition the VR-exergame may be a feasible option for performing rehabilitation exercises after hospital discharge
Objective
Primary
To investigate the effect of a 4-week VR-exergame intervention on handgrip strength in patients staying in the ICU for 48 hours or longer compared to standard rehabilitation practices
Secondary
To investigate the longer term effect of a 4-week VR-exergame intervention on handgrip strength in patients staying in the ICU for 48 hours or longer compared to standard rehabilitation practices at 12 weeks after baseline
To investigate the effect of a 4-week VR-exergame intervention on hand and arm functionality in patients staying in the ICU for 48 hours or longer compared to standard rehabilitation practices
To investigate the effect of a 4-week VR-exergame intervention on balance and mobility in patients staying in the ICU for 48 hours or longer compared to standard rehabilitation practices
To identify support needs of patients staying in the ICU for 48 hours or longer related to the use of a VR-exergame in hospital and in the home situation
Study design Multicentre mixed-methods randomised controlled trial
Study population Adult ICU patients with a length of stay in ICU of at least 48 hours
Intervention 4-week VR-exergame intervention
Main study parametersendpoints Handgrip strength measured by handheld dynamometer hand and arm functionality by Stroke Upper Limb Capacity Scale and MRC score hand and wrist range of motion balance and mobility by Morton Mobility Index and support needs by observational field notes combined with a semi-structured interview
Nature and extent of the burden and risks associated with participation benefit and group relatedness VR-based exercises have been used previously in various patient groups including ICU-patients and are a safe addition to standard healthcare Participation with this training is voluntary and an addition to the standard care physical rehabilitation protocol Patients can stop the exercise at any moment in time without having to provide an explanation The exercise activity will be guided and supervised by a trained researcher Participation in the study measurements and semi-structured interview will require mental effort but can be conducted in the patients current living situation to limit burden Overall the expected extent of the burden and risks associated with using this healthcare innovation are limited
Objective
Primary
To investigate the effect of a 4-week VR-exergame intervention on handgrip strength in patients staying in the ICU for 48 hours or longer compared to standard rehabilitation practices
Secondary
To investigate the longer term effect of a 4-week VR-exergame intervention on handgrip strength in patients staying in the ICU for 48 hours or longer compared to standard rehabilitation practices at 12 weeks after baseline
To investigate the effect of a 4-week VR-exergame intervention on hand and arm functionality in patients staying in the ICU for 48 hours or longer compared to standard rehabilitation practices
To investigate the effect of a 4-week VR-exergame intervention on balance and mobility in patients staying in the ICU for 48 hours or longer compared to standard rehabilitation practices
To identify support needs of patients staying in the ICU for 48 hours or longer related to the use of a VR-exergame in hospital and in the home situation
Study design Multicentre mixed-methods randomised controlled trial
Study population Adult ICU patients with a length of stay in ICU of at least 48 hours
Intervention 4-week VR-exergame intervention
Main study parametersendpoints Handgrip strength measured by handheld dynamometer hand and arm functionality by Stroke Upper Limb Capacity Scale and MRC score hand and wrist range of motion balance and mobility by Morton Mobility Index and support needs by observational field notes combined with a semi-structured interview
Nature and extent of the burden and risks associated with participation benefit and group relatedness VR-based exercises have been used previously in various patient groups including ICU-patients and are a safe addition to standard healthcare Participation with this training is voluntary and an addition to the standard care physical rehabilitation protocol Patients can stop the exercise at any moment in time without having to provide an explanation The exercise activity will be guided and supervised by a trained researcher Participation in the study measurements and semi-structured interview will require mental effort but can be conducted in the patients current living situation to limit burden Overall the expected extent of the burden and risks associated with using this healthcare innovation are limited
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None