Clinical trial NCT06409598: NOVEL Program for Stroke Telerehabilitation
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Stroke
Keywords: virtual reality
Telerehabilitation
Qualitative
Feasibility
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2024-05-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 100,000 people have a stroke in the UK each year and there are currently about 1.2 million UK stroke survivors. The annual UK cost of formal social care for people with stroke in 2015 was estimated at £5.2 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 user's 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.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old.
* Having stroke for more than 6 months (early or late chronic stage).
* Not participating in any other rehabilitation study.
* Able to read in English.
* Has good internet connection at home, or can the investigator give them a sim card.
* Score ≤2 on the Modified Ashworth Scale.
* Any degree of upper limb impairment due to stroke (Fugl-Meyer Assessment (FMA)-UE score \<57).
* Having sufficient space at home.
* The participant should have a laptop, computer at their home, if they don't have any of that, the investigator can loan them a laptop.

Exclusion Criteria:

* Having severe arm, leg, or spine contractures, or deformities (MAS 3 or 4).
* Having any medical contraindications (seizure disorders, symptomatic shoulder subluxation, artificial cardiac pacemaker device, persistent shoulder pain (\> 5 on VAS scale as an average).
* To ensure patients had sufficient cognitive abilities to participate in training and evaluation and to provide informed consent, the investigators will exclude patients diagnosed with - serious aphasia (cannot read the instructions) or cognitive dysfunction (inability to understand and follow two-stage instructions given by the investigators.
* To avoid potential confounding effects associated with other treatments, patients with any history of virtual reality upper-limb training or who received a botulinum toxin injection within 16 weeks before enrolment will be excluded.
* Insufficient motor control to move the avatar on the screen.
* Concurrent enrolment in another investigational study.
* Pregnancy (self reported).

Primary outcomes:
measure: Proportion of eligible participants out of screened participants
timeFrame: During the screening process
measure: Proportion of ineligible participants out of screened patients
timeFrame: During the screening process
measure: Success rate of obtaining consent from those eligible participants
timeFrame: During the enrolment process
measure: Retention rate of the participants
timeFrame: Recorded at week 8 at the end of delivering the intervention.
measure: Adherence of the participants
timeFrame: Recorded at week 8 at the end of delivering the intervention.
measure: Total number of adverse events reported by the participants using their workbook.
timeFrame: Recorded at week 8 at the end of delivering the intervention.
Secondary outcomes:
measure: Change from baseline in upper limb function on Fugl-Meyer Assessment for Upper Extremity (FMA-UE) test at week 8.
timeFrame: Completed at baseline and 8 weeks after receiving the intervention or the usual care.
measure: Change from baseline in upper limb function on action research arm test (ARAT) at week 8.
timeFrame: Completed at baseline and 8 weeks after receiving the intervention or the usual care.
measure: Change from baseline in upper limb function on The Motor Activity Log test at week 8.
timeFrame: Completed at baseline and 8 weeks after receiving the intervention or the usual care.
measure: Change from baseline in balance confidence on Activities-Specific Balance Confidence(ABC) scale at week 8.
timeFrame: Completed at baseline and 8 weeks after receiving the intervention or the usual care.
measure: Change from baseline in trunk control on Trunk Impairment Scale (TIS) at week 8.
timeFrame: Completed at baseline and 8 weeks after receiving the intervention or the usual care.
measure: Change from baseline in balance on Berg Balance Scale (BBS) at week 8.
timeFrame: Completed at baseline and 8 weeks after receiving the intervention or the usual care.
measure: User experience on User experience questionnaire (UEQ) at week 8.
timeFrame: Completed at week 8 after receiving the intervention.
measure: Physical activity enjoyment on Physical activity enjoyment scale (PACES) at week 8.
timeFrame: Completed at week 8 after receiving the intervention.
measure: Change from baseline in quality of life on the EuroQol five-dimension scale (EQ-5D) at week 8.
timeFrame: Completed at baseline and 8 weeks after receiving the intervention or the usual care.
measure: Participant experience using semi-structured interviews at the end of receiving the intervention or the usual care.
timeFrame: completed after week 8.
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: University of Exeter
Study officials:
affiliation: University of Exeter
name: Helen Dawes
role: PRINCIPAL_INVESTIGATOR
References: