NOVEL Program for Stroke Telerehabilitation

NCT ID: NCT06409598

Last Updated: 2024-08-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2025-06-30

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.

Conditions

Chronic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Non-immersive virtual reality intervention

The experimental group will receive the NOVEL (NOn-immersive Virtual reality Exercises for for upper Limb function and balance) program. This adapted program consists of 4 different non-immersive home-based virtual reality exercise games tailored for upper limb and static balance training combined with motivational strategies (performance feedback, automated progression, exercise gamification) and previously used with non-stroke populations. A videoconferencing or phone call session will be done with the main researcher once per week (Asynchronous with the sessions) to check for any technical difficulties, monitor the progression of the exercises and the progression of the difficulty levels).

Dose of exercises: the participant will have to use the exercise platforms for a minimum of 1 hour per day for 5 days per week. The total period of the intervention will be 8 weeks.

Group Type: EXPERIMENTAL

Non-immersive virtual reality home-based exercise.

Intervention Type: OTHER

This intervention aims include some exercises in the form of games to facilitate and improve the upper limb functions and static balance from sitting and standing positions among chronic stroke survivors.

Usual care

Stroke survivors assigned to the control group will continue to receive their usual care in accordance with local policies and practices. Usually, there is no available formal rehabilitation protocol for stroke survivors in the chronic stage of their recovery , but they are considered for long-term management and secondary prevention. No attempt will be made to discourage the provision of additional care, to ensure that usual care is provided. As part of the usual care trial, patients' activity records will be monitored by the researcher, in order to record any stroke care that can be provided to the patients during the trial period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Non-immersive virtual reality home-based exercise.

This intervention aims include some exercises in the form of games to facilitate and improve the upper limb functions and static balance from sitting and standing positions among chronic stroke survivors.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: collaborator

University of Exeter

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helen Dawes

Role: PRINCIPAL_INVESTIGATOR

University of Exeter

Locations

University of Exeter

Exeter, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Hatem YM lazem, Msc

Role: CONTACT

hl756@exeter.ac.uk

+447436959585

Helen Dawes, PhD

Role: CONTACT

h.dawes@exeter.ac.uk

07934675772

Facility Contacts

Hatem Lazem

Role: primary

hl756@exeter.ac.uk

Suzy Wignall

Role: backup

s.wignall@exeter.ac.uk

Other Identifiers

Stroke Telerehabilitation

Identifier Type: -

Identifier Source: org_study_id