Pilot Study of EMG-Directed Virtual-Reality Experience Training for Motor Stroke Rehabilitation

NCT05253989 | Unknown

• 1 other identifier: 21CX6751
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

Brief Summary

Novel approaches are needed for the management of stroke patients, as current practice relies on the presence of a qualified professional, of which there are severe shortages. Rehabilitation technologies provide a unique solution to this problem. Recent technological advances in EMG signal processing mean that researchers are now able to decompose EMG recordings of the residual muscle activity of stroke survivors. This information can be used to detect biomarkers of a patient's functional status, allowing an objective measure of function to be obtained. This information could be used to predict patient recovery and decide on the best course of treatment. Furthermore, this technology can be used to predict attempted patient movements, which could be used to drive a virtual reality interface that gives feedback on movement attempts. This could be delivered through a gaming interface, creating an enjoyable and motivational rehabilitation technology for stroke patients, and providing a treatment option for the most severe patients. Synchronizing patients' attempted movements with electrical stimulation of the desired muscle groups may further enhance neuroplasticity and rehabilitation outcomes. Advances in electronics have made it so electrical stimulation systems are wearable, portable and comfortable, commonplace in rehabilitation clinics and accessible to the general public (https://www.surge.co.uk/). In order to verify the clinical validity of such an approach, there is a need to conduct a large scale trial (6 months). The purpose of this study will be to assess the clinical validity of a gaming-based intervention driven by EMG activity in promoting long-term functional recovery. The study will also be assessing the capability of an AI algorithm to predict long-term recovery based on biomarkers detected in the early EMG signals. The team wishes to conduct a large scale trial to learn from the past mistakes of rehabilitation technologies, which were insufficiently powered to result in statistically significant outcomes, especially given the heterogeneous nature of the stroke population. The impact of such an intervention could be revolutionary for stroke patients. It would provide a treatment option for severe stroke patients, where none currently exists. It also ensures that rehabilitation could be commenced within the most time-critical period (the earliest weeks following stroke). Such an intervention would integrate easily into existing care practice and relieve some of the pressure on the NHS. The long-term impact would be to significantly improve the lives of stroke survivors and substantially reduce the burden on the NHS. Furthermore, the implications of this technology would go beyond stroke rehabilitation, and could be used in any patient with any form of paralysis. In order to test and validate this, the study team are also looking to include a small proportion of spinal cord injury patients in the protocol. The rationale being two-fold: they provide an alternative recruitment pool, with a simpler injury that does not also cause cognitive impairments, meaning they will be easier to collect data from and draw meaningful conclusions, in addition, it will help support that this technology can be useful in different patient groups and provide insight for future research directions. Spinal cord injury was chosen as a second condition, as like stroke it is one of the largest causes of paralysis, but tends to affect a younger patient population, which will allow us to compare the efficacy of this treatment approach in different age groups.

Conditions

Stroke; Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• The Fugl Meyer Upper Extremity Assessment

  The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226.

  Taken at 6 months post enrollment

Secondary Outcomes (6)

• Action Arm Research Test (ARAT)

  Taken at 6 months post enrollment

• Functional Independence Measure (FIM)

  Taken at 6 months post enrollment

• Modified Rankin Score (mRS)

  Taken at 6 months post enrollment

• Hospital Anxiety and Depression Score (HADS)

  Taken at 6 months post enrollment

• Faces Pain Rating Score (F-PRS)

  Taken at 6 months post enrollment

Other Outcomes (2)

• TMS asessments

  Taken at 6 months post enrollment

• Electroencephalography Assessments (EEG) with sEMG assessments

  Taken at 6 months post enrollment

Study Arms (3)

Control

NO INTERVENTION

Regular assessments as outlined in the outcomes assessment section. No other change from standard of care.

VR Intervention Group

ACTIVE COMPARATOR

Regular assessments as outlined in the outcomes assessment section. Regular VR training sessions.

Device: VR Intervention

VR Intervention + FES Group

ACTIVE COMPARATOR

Regular assessments as outlined in the outcomes assessment section. Regular VR training sessions, with FES stimulation.

Device: VR Intervention; Device: FES

Interventions

VR Intervention DEVICE

VR Device that allows a patient to play games based on the EMG activity in the upper limb.

VR Intervention + FES Group; VR Intervention Group

FES DEVICE

Functional Electrical Stimulation used to increase motor excitability whilst engaging in VR rehabilitation

VR Intervention + FES Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 or over
• Cognitive status that would permit for use /supported use of intervention device and engagement in protocol related trainings/assessment. To be indicated by treating clinician at point of screening, formal capacity assessment to be conducted as appropriate. Refer to easy read patient information sheet (PIS) and training materials to support all patients presenting with specific cognitive and/or communication needs. (patients with cognitive impairment will not be excluded as this would limit the heterogeneity of the sample and generalizability of the findings, given the prevalence of cognitive impairment in stroke patients.)
• Stroke diagnosis (can be first or subsequent stroke, unilateral haemorrhagic or ischemic) 2 weeks max post stroke at time of recruitment.
• Can communicate in English, that is, sufficient for completion of intervention and outcome measures. A speech and language therapist (SLT) will be consulted if necessary to ensure all reasonable accommodations are made to support participation.
• UL motor deficit post stroke (bilateral/unilateral) (according to National Institutes of Health Stroke Score (NIHSS) item 5), distal UL power \<1 /5 on the Oxford Rating Scale (Medical Research Council Manual Muscle Testing scale).

You may not qualify if:

• Patients already enrolled an interventional neuro rehabilitation trial.
• Patients enrolled in clinical trials that contraindicate co-enrolment.
• Patients presenting with unstable medical conditions/medical contraindications as determined by treating medical consultant (these patients may be approached at a later date should their condition improve).
• Those registered blind/with uncompensated/uncorrected visual deficits, including severe neglect that prevents them from being able to focus on visually provided feedback.
• Behavioural/affective dysfunction which could influence the ability of the person to engage with the research protocol and/or pose risk to the participating researchers (in circumstances such as follow-up community visits).
• Other concomitant neurological disorders affecting upper extremity motor function (Multiple Sclerosis, Spinal Cord Injury, Brachial Plexus or Radial Nerve Injury).
• Unremitting arm, wrist or hand pain at rest (Numeric Pain Rating Scale \> 4).
• Consumption of caffeine 2 hours prior to assessment (assessment will be postponed to a later time).
• Pre-existing UL impairment with known and significant disruption to range of motion, motor or functional performance (fracture, arthritic changes, other known musculoskeletal problems). Or pre-modified Rankin Score \> 2.
• Skin condition apparent on the ventral UE such that might place participant at risk of irritation in the context of repeated physical contact (such as that associated with the intervention).
• Subsequent MRI that fails to confirm stroke
• Chronic stroke patients whose stroke occurred in excess of 2.5 years ago
• Patients whose cognitive impairment prevents them from following instructions
• Intervention Group Only: Patients with uncontrolled photosensitive epilepsy/Other neurological symptoms that may be exacerbated by required focus on LED screen/moving object on screen).
• Pregnancy

Sponsors & Collaborators

• Imperial College London: lead

MeSH Terms

Conditions

Stroke; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Spinal Cord Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Paul Bentley

  Charing Cross Hospital: Neurology Consultant

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Bentley

CONTACT

02033111184; p.bentley@imperial.ac.uk

Megan Hutchings

CONTACT

07305992813; m.hutchings19@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Control Group comprises 28 patients. Receive no intervention, but do receive regular assessments. Control Group patients can then decide to be involved in one of the intervention arms. Intervention Groups are split evenly between FES and non-FES. Non-FES group receives VR intervention (VR training for rehabilitation). FES group receives the same, but with the addition of FES during the intervention.

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 24, 2022
• Study Start: May 1, 2022
• Primary Completion: March 31, 2024
• Study Completion: October 30, 2024
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share