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Virtual Environment Rehabilitation for Patients With Motor Neglect Trial (VERMONT)

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ClinicalTrials.gov Identifier: NCT03887962
Recruitment Status : Enrolling by invitation
First Posted : March 25, 2019
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Nicholas Shenker, Cambridge University Hospitals NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Complex Regional Pain Syndromes Fibromyalgia Stroke Traumatic Brain Injury Osteoarthritis Back Pain Sciatica Device: Virtual Environment Biofeedback Device: Treadmill walking with no Virtual Environment Biofeedback Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised single-blind controlled trial
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
Primary Purpose: Treatment
Official Title: Trial of Virtual Reality Biofeedback in Patients With Motor Neglect From Chronic Pain or Cerebrovascular Disease
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Device: Virtual Environment Biofeedback
Treadmill walking. Modified available technology for gait capture. Tailored software for virtual environment rendering and immersive qualities
Other Name: Real time biofeedback

Active Comparator: 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.
Device: Treadmill walking with no Virtual Environment Biofeedback
Treadmill walking. Flat screen / no virtual environment to act as attentional control.
Other Name: Control group




Primary Outcome Measures :
  1. Distance walked (machine-reported) [ Time Frame: Week 2 ]
    Distance walked in 5 minutes at weeks 2 compared to baseline (% change)

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Brief Pain Inventory [ Time Frame: Weeks 2,12,24 ]
    Self-reported questionnaire - mean score (11-point analogue scale). High scores indicate more pain. % change from baseline will be calculated

  2. Human Activity Profile [ Time Frame: Weeks 2,12,24 ]
    Self-reported questionnaire (0-94 points). Low scores indicate loss of function.

  3. Hospital Anxiety and Depression Scale [ Time Frame: Weeks 2,12,24 ]
    Self-reported questionnaire (0-21 on each dimension of Anxiety and Depression). High scores indicate high Anxiety or Depression

  4. Neglect Like Symptom Questionnaire [ Time Frame: Weeks 2,12,24 ]
    Self-reported questionnaire (1-6). High scores indicate more Neglect-like symptoms

  5. Satisfaction questionnaire [ Time Frame: Weeks 2, 24 ]
    Self-reported questionnaire. 0-5 score. High scores indicate high satisfaction

  6. Machine-reported average stride length [ Time Frame: Week 2 ]
    Average stride length (cm)

  7. Machine-reported number of steps [ Time Frame: Week 2 ]
    Number of steps (whole number)

  8. Machine-reported gait symmetry [ Time Frame: Week 2 ]
    Asymmetry (left-right split presented in numerical form)

  9. Machine-reported gait timing [ Time Frame: Week 2 ]
    Timing (Proportion of gait with planted foot and raised foot measured as %).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03887962


Locations
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United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Nicholas GN Shenker, MD Cambridge University Hospitals NHS Foundation Trust

Publications:

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Responsible Party: Dr Nicholas Shenker, Consultant Rheumatologist, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03887962     History of Changes
Other Study ID Numbers: A092932
17/LO/0299 ( Other Identifier: UK Research Ethics Committee )
74696 ( Other Identifier: IRAS )
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Nicholas Shenker, Cambridge University Hospitals NHS Foundation Trust:
Motor Neglect
Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Fibromyalgia
Brain Injuries
Brain Injuries, Traumatic
Sciatica
Back Pain
Musculoskeletal Diseases
Rheumatic Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Muscular Diseases
Neuromuscular Diseases
Autonomic Nervous System Diseases
Peripheral Nervous System Diseases
Sciatic Neuropathy
Mononeuropathies
Neuralgia