Status:
UNKNOWN
Pilot Study of EMG-Directed Virtual-Reality Experience Training for Motor Stroke Rehabilitation
Lead Sponsor:
Imperial College London
Conditions:
Stroke
Spinal Cord Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
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 technolog...
Detailed Description
Study Design: Main Study: An interventional study conducted in both acute stroke patients and chronic stroke patients, as well as spinal cord injury patients, to validate the use of a virtual-reality...
Eligibility Criteria
Inclusion
- 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).
- Sub Study Only: The Sub Study will use identical inclusion criteria to the main study, except for the degree of motor impairment, where patients with UL distal power up to 3/5 will be accepted.
Exclusion
- 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
- Patients will be excluded from the TMS assessment if they meet any of the following additional criteria:
- Epilepsy episodes or previous convulsion or a seizure episodes
- Fainting spell or syncope in the past, it should be described on which occasion(s)
- Head trauma diagnosed as a concussion or associated with loss of consciousness
- Hearing problems or ringing in the ears
- Cochlear implants
- Metal in the brain, skull or elsewhere in the body
- Implanted neurostimulator
- Cardiac pacemaker or intracardiac lines
- Medication infusion device
- Taking medications that can interfere with neural function
- History of migraines
- Previous neurologic, musculoskeletal or mental illnesses
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2024
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT05253989
Start Date
May 1 2022
End Date
October 30 2024
Last Update
April 25 2022
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