Virtual Environment Rehabilitation for Patients With Motor Neglect Trial
Virtual Environment Rehabilitation for Patients With Motor Neglect Trial
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.
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.

 Inclusion criteria

 -  Patients with a diagnosis of stroke (of any cause), traumatic brain injury or a 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. 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.

 -  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.

 Sample size This will be calculated using standard models. It is unknown what the effect size
 will be. Alpha will be 0.05, Beta will be 0.2. It is likely that at least 20 patients will
 need to be recruited in each arm (40 in total). Estimating the likely recruitment target from
 the numbers of patients requiring inpatients rehabilitation at Addenbrooke's (n=400 per annum
 for stroke, traumatic brain injury, back pain and Complex Regional Pain Syndrome), this would
 require a 12-month window of recruitment, assuming approximately 10% successful enrolment
 (n=40).

 Withdrawal criteria Patients who wish to withdraw will be allowed to do so with out this
 affecting their rehabilitation.

 Randomisation Subjects will be randomised to either the study or control group using a
 concealed blind allocation. This will be performed by a group independent from the trial.

 Subjects will be allocated to the study:control groups on a 1:1 ratio using a random number
 generator (e.g. www.mathgoodies.com/calculators/random_no_custom.html) to determine the order
 of the couplets.

 The exception will be applied to the groups who are successfully screened (e.g. Back Pain
 Programme). For this purpose, the entire group will be randomised to either receiving control
 or intervention due to cross-contamination of the treatment effect within a single group
 receiving otherwise identical rehabilitation.

 Blinding Patients and therapists can not be blinded due to the nature of the research. Data
 analysis will be conducted by members of the trial research group who are blinded to whether
 an individual patient received the experimental or control arm. This will be achieved by the
 use of data stripped of any patient identifiable content and divided into the two groups.
 This task will be performed by the senior physiotherapist supervising the project. There
 should be no necessity to 'unblind' subjects from the study due to the lack of any clear
 serious side effects associated with the intervention.

 Intervention Patients will be randomly assigned to one of two groups: intervention or
 control.

 Both groups will walk on a treadmill as part of the task. Walking on the treadmill will be
 explained and demonstrated, and the subjects will have time to practice this task before this
 study commences. For extra safety, the subjects will be allowed to use the handlebars of the
 treadmill for extra support if they wish. The therapy assistant will stand next to the
 Emergency stop button and is fully trained in the use of the treadmill and Virtual
 Environment device.

 In both groups the walking cycles will be determined by their functional ability as assessed
 by the screening physiotherapist but the treadmill walking will not be longer than 5 minutes
 at each cycle. Every 30 seconds, the therapy assistant will ask whether the subject would
 like to change the speed of the treadmill and will make a decision based on his experience as
 to whether to increase the treadmill by 0.1 km/h or reduce / stop the treadmill as necessary.
 The next cycle will start at the speed at which the previous cycle finished. The next day's
 session will commence at baseline speed and increase or decrease as above. The subject will
 be required to complete five walking cycles and will have up to a 3 minute break between each
 cycle. The primary outcome will be the distance walked in the final 5-minute cycle of the
 session at Baseline, week 2 and at 24 weeks. This task will be performed 3 to 4 times per
 week for two weeks. The speed of each cycle will be set back to baseline for each day.

 Intervention group:
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.