Virtual Environment Rehabilitation for Patients With Motor Neglect Trial

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.

Conditions

• Complex Regional Pain Syndromes
• Fibromyalgia
• Stroke
• Traumatic Brain Injury
• Osteoarthritis
• Back Pain
• Sciatica

Interventions

DEVICE

Virtual Environment Biofeedback

Treadmill walking. Modified available technology for gait capture. Tailored software for virtual environment rendering and immersive qualities

DEVICE

Treadmill walking with no Virtual Environment Biofeedback

Treadmill walking. Flat screen / no virtual environment to act as attentional control.

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust

  lead OTHER

Principal Investigators

• Nicholas GN Shenker, MD · Cambridge University Hospitals NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-05-01

Primary Completion

2021-07-01

Completion

2021-11-01

Countries

• United Kingdom

Study Locations