Please select the outcome measures that correspond to the clinical trial below.
Title: Trial of Virtual Reality Biofeedback in Patients With Motor Neglect From Chronic Pain or Cerebrovascular Disease
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.


Options:
A: Distance walked (machine-reported) (Week 2); Lower Extremity Functional Index (Week 2); Lower Extremity Functional Index (Week 24)
B: Behavioural Inattention Test (BIT) (Change in BIT score between the baseline sessions average and score measured at week 11)
C: Change in the result of Fugl-Meyer assessment for UE motor function (baseline, endpoint (6 weeks) and follow up (18 weeks)); Change in the result of Modified Ashworth scale (MAS) (baseline, endpoint (6 weeks) and follow up (18 weeks)); Change in the result of Box and blocks test (baseline, endpoint (6 weeks) and follow up (18 weeks)); Change in the result of Semmes-Weinstein monofilament (SWM) test (baseline, endpoint (6 weeks) and follow up (18 weeks)); Change in the result of Motor Activity Log (baseline, endpoint (6 weeks) and follow up (18 weeks))
D: Neglect symptom severity (neuropsychological test performance) (Intra-individual difference of the outcome's change during 3 weeks Intervention versus 3 weeks Control phase, i.e. (T3 on Day 21 - T2 on Day 1) - (T5 on Day 42 - T4 on Day 22)); Neglect-related functional disability (Intra-individual difference of the outcome's change during 3 weeks Intervention versus 3 weeks Control phase, i.e. (T3 on Day 21 - T2 on Day 1) - (T5 on Day 42 - T4 on Day 22))

Answer: A