Trial of Virtual Reality Biofeedback in Patients With Motor Neglect From Chronic Pain or Cerebrovascular Disease
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Distance walked (machine-reported)
Study Overview
Brief Summary
Motor neglect describes a loss of function without a loss of strength, reflexes or sensation. Motor neglect has been described in patients with traumatic brain injury, stroke and chronic pain conditions, e.g. complex regional pain syndrome. These conditions affect hundreds of thousands of patients in the UK each year and motor neglect is a significant obstacle in their rehabilitation towards a good outcome. By focussing on improving motor neglect, outcomes including function and quality of life for these groups of patients may significantly improve.
Motor neglect is potentially reversible. Rehabilitation using repetition, feedback and motivation are beneficial for optimal outcome. Current protocols use face-to-face physical therapies which can not optimise intensity due to a lack of resources. Furthermore, engagement with exercise is recognised to be poor, in part, due to a lack of attention. Innovative technologies may well improve engagement. Furthermore, telemedicine, or remote delivery of healthcare, offer opportunities in resource management, which can be delivered through the use of such innovative technologies.
Virtual reality systems have been designed and utilised in rehabilitation in various conditions, e.g post-stroke, cerebral palsy and Parkinson's disease. Studies demonstrate improved function in both upper and lower limbs. Potentially more effective treatments for motor neglect utilising such technology are therefore available but need more formal evaluation.
This protocol describes a Phase II randomised controlled trial for both in-patients and out-patients requiring rehabilitation with motor neglect from neurological causes (stroke, traumatic brain injury) and chronic pain conditions (Complex Regional Pain Syndromes, chronic low back pain and referred leg pain (sciatica)). The intervention will be a novel interactive virtual reality system using established technology and tailored software used in conjunction with a treadmill. The control group will be the same screen showing random static images whilst on the treadmill. Rehabilitation for each group will be offered in 3-4 sessions per week for 2 weeks. Each session will last about 30 minutes supervised by a physiotherapist. Follow-up will be by questionnaire at weeks 2, 6 and 12 and by face-to-face consultation at weeks 2 and 12.
Detailed Description
To investigate whether a virtual reality biofeedback system in conjunction with a treadmill is safe and feasible for the rehabilitation of patients with motor neglect due to chronic pain conditions, traumatic brain injury and stroke compared to a control group of patients with these conditions whose rehabilitation consists of a non-virtual reality screen and treadmill.
To investigate whether a virtual reality biofeedback system in conjunction with a treadmill can improve outcome such as distance walked, pain, function, emotional well being and activity.
Study Design Randomised single-blind controlled trial
Setting The study will take place as part of the normal rehabilitation programmes at the single centre of Addenbrookes's Hospital, Cambridge University Hospitals NHS Foundation Trust. The treadmill gait task will be undertaken in the Clinical Movement Laboratory in Clinic 9 (Orthotics and Prosthetics Department).
Study population Subjects will be recruited from patients attending in-patient and out-patient rehabilitation programmes for chronic pain conditions or neurological conditions. Suitable candidates will be identified by the consultants or therapists involved in the programme. With consent, potential subjects will be referred to the researchers for screening.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Data collected by unblended participant and research assistant. Outcomes analysed by blinded team and statistician Objective machine outcomes are blinded
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients with a diagnosis of stroke (of any cause), traumatic brain injury or chronic pain condition of more than 3 months duration (e.g. back and referred leg pain; complex regional pain syndrome; fibromyalgia) who are undergoing an inpatient or out-patient rehabilitation programme
- •Motor neglect as assessed by standard clinical examination by a physiotherapist trained to detect such motor neglect (EV). This is defined as weakness and functional impairment without a loss of strength, reflexes or sensation.
Exclusion Criteria
- •Patients with active serious medical problems that might affect their ability to participate in the exercise protocol (e.g. ongoing sepsis; recent myocardial infarction)
- •Patients who are unable to use treadmill safely as judged by the screening physiotherapist (EV).
- •Patients who are unable to give informed consent, either through issues relating to competency or to language.
- •Patients with significant previous experience of virtual reality rehabilitation.
Arms & Interventions
Virtual Environment feedback
Subjects will be instructed to walk on a treadmill, moving at a constant speed, following a "virtual path" displayed on a flat screen in front of them. In this group, the gait task may involve avoiding virtual obstacles on the screen in the path or stepping on targets as determined by the therapist.
Intervention: Virtual Environment Biofeedback (Device)
Control
Subjects will be instructed to walk on a treadmill, moving at a constant speed. The flat screen will play random scenes from the virtual reality environment and thus control for attentional and non-movement related clues.
Intervention: Treadmill walking with no Virtual Environment Biofeedback (Device)
Outcomes
Primary Outcomes
Distance walked (machine-reported)
Time Frame: Week 2
Distance walked in 5 minutes at weeks 2 compared to baseline (% change)
Lower Extremity Functional Index
Time Frame: Week 24
Self-reported 20-question Functional Activity Questionnaire with minimal clinically important difference of 9 (range 0-80). Each question scored 0-4. Low scores indicate less function.
Lower Extremity Functional Index
Time Frame: Week 2
Self-reported 20-question Functional Activity Questionnaire with minimal clinically important difference of 9 (range 0-80). Each question scored 0-4. Low scores indicate less function.
Secondary Outcomes
- Machine-reported average stride length(Week 2)
- Machine-reported number of steps(Week 2)
- Brief Pain Inventory(Weeks 2,12,24)
- Human Activity Profile(Weeks 2,12,24)
- Hospital Anxiety and Depression Scale(Weeks 2,12,24)
- Neglect Like Symptom Questionnaire(Weeks 2,12,24)
- Machine-reported gait timing(Week 2)
- Satisfaction questionnaire(Weeks 2, 24)
- Machine-reported gait symmetry(Week 2)
Investigators
Dr Nicholas Shenker
Consultant Rheumatologist
Cambridge University Hospitals NHS Foundation Trust