Virtual Environment Rehabilitation for Patients With Motor Neglect Trial (VERMONT)
Primary Purpose
Complex Regional Pain Syndromes, Fibromyalgia, Stroke
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Virtual Environment Biofeedback
Treadmill walking with no Virtual Environment Biofeedback
Sponsored by
About this trial
This is an interventional treatment trial for Complex Regional Pain Syndromes focused on measuring Motor Neglect
Eligibility 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.
Sites / Locations
- Cambridge University Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Virtual Environment feedback
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Distance walked (machine-reported)
Distance walked in 5 minutes at weeks 2 compared to baseline (% change)
Lower Extremity Functional Index
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
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
Brief Pain Inventory
Self-reported questionnaire - mean score (11-point analogue scale). High scores indicate more pain. % change from baseline will be calculated
Human Activity Profile
Self-reported questionnaire (0-94 points). Low scores indicate loss of function.
Hospital Anxiety and Depression Scale
Self-reported questionnaire (0-21 on each dimension of Anxiety and Depression). High scores indicate high Anxiety or Depression
Neglect Like Symptom Questionnaire
Self-reported questionnaire (1-6). High scores indicate more Neglect-like symptoms
Satisfaction questionnaire
Self-reported questionnaire. 0-5 score. High scores indicate high satisfaction
Machine-reported average stride length
Average stride length (cm)
Machine-reported number of steps
Number of steps (whole number)
Machine-reported gait symmetry
Asymmetry (left-right split presented in numerical form)
Machine-reported gait timing
Timing (Proportion of gait with planted foot and raised foot measured as %).
Full Information
NCT ID
NCT03887962
First Posted
March 19, 2019
Last Updated
January 12, 2021
Sponsor
Cambridge University Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT03887962
Brief Title
Virtual Environment Rehabilitation for Patients With Motor Neglect Trial
Acronym
VERMONT
Official Title
Trial of Virtual Reality Biofeedback in Patients With Motor Neglect From Chronic Pain or Cerebrovascular Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
November 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cambridge University Hospitals NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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:
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndromes, Fibromyalgia, Stroke, Traumatic Brain Injury, Osteoarthritis, Back Pain, Sciatica
Keywords
Motor Neglect
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised single-blind controlled trial
Masking
Outcomes Assessor
Masking Description
Data collected by unblended participant and research assistant. Outcomes analysed by blinded team and statistician Objective machine outcomes are blinded
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual Environment feedback
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Virtual Environment Biofeedback
Other Intervention Name(s)
Real time biofeedback
Intervention Description
Treadmill walking. Modified available technology for gait capture. Tailored software for virtual environment rendering and immersive qualities
Intervention Type
Device
Intervention Name(s)
Treadmill walking with no Virtual Environment Biofeedback
Other Intervention Name(s)
Control group
Intervention Description
Treadmill walking. Flat screen / no virtual environment to act as attentional control.
Primary Outcome Measure Information:
Title
Distance walked (machine-reported)
Description
Distance walked in 5 minutes at weeks 2 compared to baseline (% change)
Time Frame
Week 2
Title
Lower Extremity Functional Index
Description
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.
Time Frame
Week 2
Title
Lower Extremity Functional Index
Description
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.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Brief Pain Inventory
Description
Self-reported questionnaire - mean score (11-point analogue scale). High scores indicate more pain. % change from baseline will be calculated
Time Frame
Weeks 2,12,24
Title
Human Activity Profile
Description
Self-reported questionnaire (0-94 points). Low scores indicate loss of function.
Time Frame
Weeks 2,12,24
Title
Hospital Anxiety and Depression Scale
Description
Self-reported questionnaire (0-21 on each dimension of Anxiety and Depression). High scores indicate high Anxiety or Depression
Time Frame
Weeks 2,12,24
Title
Neglect Like Symptom Questionnaire
Description
Self-reported questionnaire (1-6). High scores indicate more Neglect-like symptoms
Time Frame
Weeks 2,12,24
Title
Satisfaction questionnaire
Description
Self-reported questionnaire. 0-5 score. High scores indicate high satisfaction
Time Frame
Weeks 2, 24
Title
Machine-reported average stride length
Description
Average stride length (cm)
Time Frame
Week 2
Title
Machine-reported number of steps
Description
Number of steps (whole number)
Time Frame
Week 2
Title
Machine-reported gait symmetry
Description
Asymmetry (left-right split presented in numerical form)
Time Frame
Week 2
Title
Machine-reported gait timing
Description
Timing (Proportion of gait with planted foot and raised foot measured as %).
Time Frame
Week 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas GN Shenker, MD
Organizational Affiliation
Cambridge University Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17351691
Citation
Acerra NE, Souvlis T, Moseley GL. Stroke, complex regional pain syndrome and phantom limb pain: can commonalities direct future management? J Rehabil Med. 2007 Mar;39(2):109-14. doi: 10.2340/16501977-0027.
Results Reference
background
PubMed Identifier
17271420
Citation
Adamovich SV, Merians AS, Boian R, Tremaine M, Burdea GS, Recce M, Poizner H. A virtual reality based exercise system for hand rehabilitation post-stroke: transfer to function. Conf Proc IEEE Eng Med Biol Soc. 2004;2004:4936-9. doi: 10.1109/IEMBS.2004.1404364.
Results Reference
background
PubMed Identifier
18689607
Citation
Deutsch JE, Borbely M, Filler J, Huhn K, Guarrera-Bowlby P. Use of a low-cost, commercially available gaming console (Wii) for rehabilitation of an adolescent with cerebral palsy. Phys Ther. 2008 Oct;88(10):1196-207. doi: 10.2522/ptj.20080062. Epub 2008 Aug 8.
Results Reference
background
PubMed Identifier
9132689
Citation
Flor H, Braun C, Elbert T, Birbaumer N. Extensive reorganization of primary somatosensory cortex in chronic back pain patients. Neurosci Lett. 1997 Mar 7;224(1):5-8. doi: 10.1016/s0304-3940(97)13441-3.
Results Reference
background
PubMed Identifier
15971970
Citation
Holden MK. Virtual environments for motor rehabilitation: review. Cyberpsychol Behav. 2005 Jun;8(3):187-211; discussion 212-9. doi: 10.1089/cpb.2005.8.187.
Results Reference
background
PubMed Identifier
12511859
Citation
Husain M, Rorden C. Non-spatially lateralized mechanisms in hemispatial neglect. Nat Rev Neurosci. 2003 Jan;4(1):26-36. doi: 10.1038/nrn1005. No abstract available.
Results Reference
background
PubMed Identifier
20189810
Citation
Mirelman A, Patritti BL, Bonato P, Deutsch JE. Effects of virtual reality training on gait biomechanics of individuals post-stroke. Gait Posture. 2010 Apr;31(4):433-7. doi: 10.1016/j.gaitpost.2010.01.016. Epub 2010 Mar 1.
Results Reference
background
PubMed Identifier
21474804
Citation
Saposnik G, Levin M; Outcome Research Canada (SORCan) Working Group. Virtual reality in stroke rehabilitation: a meta-analysis and implications for clinicians. Stroke. 2011 May;42(5):1380-6. doi: 10.1161/STROKEAHA.110.605451. Epub 2011 Apr 7.
Results Reference
background
PubMed Identifier
20202141
Citation
Sato K, Fukumori S, Matsusaki T, Maruo T, Ishikawa S, Nishie H, Takata K, Mizuhara H, Mizobuchi S, Nakatsuka H, Matsumi M, Gofuku A, Yokoyama M, Morita K. Nonimmersive virtual reality mirror visual feedback therapy and its application for the treatment of complex regional pain syndrome: an open-label pilot study. Pain Med. 2010 Apr;11(4):622-9. doi: 10.1111/j.1526-4637.2010.00819.x. Epub 2010 Mar 1.
Results Reference
background
PubMed Identifier
22654062
Citation
van den Brand R, Heutschi J, Barraud Q, DiGiovanna J, Bartholdi K, Huerlimann M, Friedli L, Vollenweider I, Moraud EM, Duis S, Dominici N, Micera S, Musienko P, Courtine G. Restoring voluntary control of locomotion after paralyzing spinal cord injury. Science. 2012 Jun 1;336(6085):1182-5. doi: 10.1126/science.1217416.
Results Reference
background
PubMed Identifier
20103405
Citation
Walker ML, Ringleb SI, Maihafer GC, Walker R, Crouch JR, Van Lunen B, Morrison S. Virtual reality-enhanced partial body weight-supported treadmill training poststroke: feasibility and effectiveness in 6 subjects. Arch Phys Med Rehabil. 2010 Jan;91(1):115-22. doi: 10.1016/j.apmr.2009.09.009.
Results Reference
background
PubMed Identifier
34196963
Citation
Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.
Results Reference
derived
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Virtual Environment Rehabilitation for Patients With Motor Neglect Trial
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