Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409598
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-05-07
Brief Title:
NOVEL Program for Stroke Telerehabilitation
Sponsor:
University of Exeter
Organization:
University of Exeter
Study Overview
Official Title:
Efficacy of NOn-immersive Virtual Reality Adapted Telerehabilitation Exercises for Upper Limb Function and Balance NOVEL Program in Stroke Patients A Mixed Method Pilot Feasibility Study
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
Strokes are estimated to be the third most common cause of death in the world and the second most common cause of disability Recently the incidence of stroke has increased due to population aging It is common for stroke survivors to experience a functional decline in their capacity to carry out daily activities as a consequence of their increasing dependence which ultimately affects motivation levels self-efficacy and quality of life Following a stroke people often experience problems with upper limb function Over half of people with upper limb impairments who have suffered a stroke continue to experience problems months or years afterward
A significant amount of rehabilitation is necessary to obtain meaningful recovery in the upper extremities and balance but such interventions are difficult to access
As a cutting-edge method of neurorehabilitation extended reality technology like virtual reality provides a more intensive simulation of functional activities than traditional physical therapy methods aerobic resistance flexibility exercises balance and coordination training and functional exercises The non-immersive type of VR can provide the patient with a safe experience so they can practice their exercises using gamification features integrated into the VR system while remaining aware of their surroundings
According to the most recently published studies there is promising evidence regarding the use of home-based exercises in stroke management especially after the Covid-19 pandemic However there is still a gap in identifying the evidence for using non-immersive home-based virtual reality exercises as telerehabilitation on the upper limb function and balance motor outcomes adherence and compliance with rehabilitation programs In addition no study have evaluated the validity and fidelity of the gamified features that can be added to the non-immersive VR exercises in terms of improving patient adherence and experience to their rehabilitation program Moreover the investigators still need rigorous qualitative studies to explore patient experiences after doing these exercises at home with remote monitoring from their rehabilitation team
A significant amount of rehabilitation is necessary to obtain meaningful recovery in the upper extremities and balance but such interventions are difficult to access
As a cutting-edge method of neurorehabilitation extended reality technology like virtual reality provides a more intensive simulation of functional activities than traditional physical therapy methods aerobic resistance flexibility exercises balance and coordination training and functional exercises The non-immersive type of VR can provide the patient with a safe experience so they can practice their exercises using gamification features integrated into the VR system while remaining aware of their surroundings
According to the most recently published studies there is promising evidence regarding the use of home-based exercises in stroke management especially after the Covid-19 pandemic However there is still a gap in identifying the evidence for using non-immersive home-based virtual reality exercises as telerehabilitation on the upper limb function and balance motor outcomes adherence and compliance with rehabilitation programs In addition no study have evaluated the validity and fidelity of the gamified features that can be added to the non-immersive VR exercises in terms of improving patient adherence and experience to their rehabilitation program Moreover the investigators still need rigorous qualitative studies to explore patient experiences after doing these exercises at home with remote monitoring from their rehabilitation team
Detailed Description:
Physical recovery from stroke requires very large numbers of high-quality repetitive task-directed movements conventionally delivered face-to-face by therapists and assistants Stroke is the single largest cause of complex disability in the UK NHS LTP Around 100000 people have a stroke in the UK each year and there are currently about 12 million UK stroke survivors The annual UK cost of formal social care for people with stroke in 2015 was estimated at 52 billion and is expected to more than triple by 2035 Strokes are estimated to be the third most common cause of death in the world and the second most common cause of disability Recently the incidence of stroke has increased due to population aging It is common for stroke survivors to experience a functional decline in their capacity to carry out daily activities as a consequence of their increasing dependence which ultimately affects motivation levels self-efficacy and quality of life
Following a stroke people often experience problems with upper limb function Over half of people with upper limb impairments who have suffered a stroke continue to experience problems months or years afterward A common symptom of these upper limb impairments is difficulty moving and coordinating the arms hands and fingers which may make it challenging to carry out daily tasks such as eating dressing and cleaning Enhancing arm function is therefore an essential component of rehabilitation An array of possible interventions have been developed including different exercises or training specialist equipment or techniques splints or the use of a drug to facilitate arm movement Botox injections
In stroke patients balance impairment is one of the biggest obstacles to independence Balance could be classified into static balance and dynamic balance Many peope with stroke experience reduced balance due to deficits in motor control Maintaining an upright posture to maintain balance requires good motor control poor postural control adversely affects balance In stroke patients decreased static and dynamic balance poses a significant risk for falls and limits their ability to perform daily tasks Therefore restoring functional balance is one of the main goals of stroke rehabilitation and restoring proper postural control is essential in order to be able to carry out daily living activities independently
A significant amount of rehabilitation is necessary to obtain meaningful recovery in the upper extremities and balance but such interventions are difficult to access Inpatient rehabilitation is generally only permitted for a short period of time and outpatient rehabilitation is limited in duration Accordingly home-based rehabilitation plays a crucial role in the rehabilitation continuum allowing continuous and sufficient rehabilitation over a prolonged period of time thereby improving function Home-based rehabilitation or self-training are also important considering patients mobility issues transportation problems or caregiver issues when trying to access rehabilitation facilities
Its virtual environment provides users with the opportunity to learn and practice their exercise in a highly motivating and adherence-enhancing environment utilizing motivational gamified elements music exercise scenarios visual or auditory feedback in order to provide a number of advantages for motivating behavior change The user experiences the virtual environment through visual and audio feedback using a head-mounted device flat screen or projection system It presents the opportunity for motor learning by testing the users ability to solve problems and master real-world skills in a virtual environment by giving feedback In considering all of the gamified features that are included in a rehabilitation program it is important to ensure that they achieve the objectives of the rehabilitation program in which they are incorporated validity
Based on the recent published literatures most of the studies that used different types of extended reality used devices utilised the Kinect camera or other devices that may not be affordable or easily accessible in terms of setting up to stroke survivors To create real-world scenarios the investigators have brought together the Exeter and Sao Paulo teams who have world-class expertise in developing VR software The investigators intend to use some non-immersive VR adapted exercise scenarios with many levels of difficulties designed to be suitable and safe for home-based rehabilitation The investigators have conducted a content validity and usability study with stroke survivors and physiotherapists aiming to refine these exercises to be more tailored and suitable to be delivered to stroke people at their homes Based on this study the investigators have found a good degree of agreement among the physiotherapist and stroke survivors regarding the suitability of these exercises for stroke home rehabilitation taking in consideration some suggestions to be more tailored according to patients abilities Based on these results the investigators have created our newly adapted NOVEL program taking in considerations some important key features to be implemented in the newly developed exercises
The overall aim of this mixed method feasibility RCT pilot study is to evaluate the feasibility and efficacy of a non-immersive VR home-based exercise program compared to a usual care among stroke survivors
Following a stroke people often experience problems with upper limb function Over half of people with upper limb impairments who have suffered a stroke continue to experience problems months or years afterward A common symptom of these upper limb impairments is difficulty moving and coordinating the arms hands and fingers which may make it challenging to carry out daily tasks such as eating dressing and cleaning Enhancing arm function is therefore an essential component of rehabilitation An array of possible interventions have been developed including different exercises or training specialist equipment or techniques splints or the use of a drug to facilitate arm movement Botox injections
In stroke patients balance impairment is one of the biggest obstacles to independence Balance could be classified into static balance and dynamic balance Many peope with stroke experience reduced balance due to deficits in motor control Maintaining an upright posture to maintain balance requires good motor control poor postural control adversely affects balance In stroke patients decreased static and dynamic balance poses a significant risk for falls and limits their ability to perform daily tasks Therefore restoring functional balance is one of the main goals of stroke rehabilitation and restoring proper postural control is essential in order to be able to carry out daily living activities independently
A significant amount of rehabilitation is necessary to obtain meaningful recovery in the upper extremities and balance but such interventions are difficult to access Inpatient rehabilitation is generally only permitted for a short period of time and outpatient rehabilitation is limited in duration Accordingly home-based rehabilitation plays a crucial role in the rehabilitation continuum allowing continuous and sufficient rehabilitation over a prolonged period of time thereby improving function Home-based rehabilitation or self-training are also important considering patients mobility issues transportation problems or caregiver issues when trying to access rehabilitation facilities
Its virtual environment provides users with the opportunity to learn and practice their exercise in a highly motivating and adherence-enhancing environment utilizing motivational gamified elements music exercise scenarios visual or auditory feedback in order to provide a number of advantages for motivating behavior change The user experiences the virtual environment through visual and audio feedback using a head-mounted device flat screen or projection system It presents the opportunity for motor learning by testing the users ability to solve problems and master real-world skills in a virtual environment by giving feedback In considering all of the gamified features that are included in a rehabilitation program it is important to ensure that they achieve the objectives of the rehabilitation program in which they are incorporated validity
Based on the recent published literatures most of the studies that used different types of extended reality used devices utilised the Kinect camera or other devices that may not be affordable or easily accessible in terms of setting up to stroke survivors To create real-world scenarios the investigators have brought together the Exeter and Sao Paulo teams who have world-class expertise in developing VR software The investigators intend to use some non-immersive VR adapted exercise scenarios with many levels of difficulties designed to be suitable and safe for home-based rehabilitation The investigators have conducted a content validity and usability study with stroke survivors and physiotherapists aiming to refine these exercises to be more tailored and suitable to be delivered to stroke people at their homes Based on this study the investigators have found a good degree of agreement among the physiotherapist and stroke survivors regarding the suitability of these exercises for stroke home rehabilitation taking in consideration some suggestions to be more tailored according to patients abilities Based on these results the investigators have created our newly adapted NOVEL program taking in considerations some important key features to be implemented in the newly developed exercises
The overall aim of this mixed method feasibility RCT pilot study is to evaluate the feasibility and efficacy of a non-immersive VR home-based exercise program compared to a usual care among stroke survivors
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