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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Cerebrovascular diseasesInjuries to unspecified part of trunk, limb or body region
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Design: An interventional study conducted in both acute stroke patients and chronic stroke patients,to validate the use of technology-based rehabilitation therapy. Data from the control group (not receiving additional therapy as usual care) and the intervention group data will be collected (approximately 29 patients each). We will also complete a sub study using a similar design and recruitment number as the EMG-based intervention where we include functional electrical stimulation and robotics.
Aims: To validate the use of an EMG-based virtual reality interface for use in the rehabilitation of stroke patients. To determine if there are biomarkers present in the EMG data that can be used to predict and inform on patient recovery. Generating experimental evidence on how to optimise rehabilitation,according to cognitive load,motor task and force generation.
Outcome Measures: The primary end point outcome will be the Fugl Meyer Upper Extremity Assessment (FM-UE) at 3 months,controlled for baseline. Additional outcome measures will include: The Action Arm Research Test (ARAT),Functional Independence Measure (FIM),Modified Rankin Scale (mRS),Hospital Anxiety and Depression Scale (HADS),Faces Pain Rating Scale (FPRS),Stanford Fatigue Visual Numeric Scale (SFVNS),Patient Questionnaires (see Appendix),Device Recordings (EMG data,game performance metrics,exercise time).
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Type: Device;Rehabilitation;
You can take part if:
You may not be able to take part 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 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 Pregnancy 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 Sub Study Only: Participants will be excluded from FES therapy if they meet any of the main study exclusion criteria and/or the following additional criteria: Cannot attend the hospital for their assessment and therapy sessions No therapist available to supervise the patient Active implantable devices (e.g. pace maker),or metal implants within the stimulated area Cancer or wounds in the electrode application area No hand or wrist motion is witnessed when electrical stimulation is applied to the forearm (e.g. severe atrophy) Peripheral nerve damage (e.g.,Polyneuropathy) Unremitting arm,wrist or hand pain at rest or during FES (Numeric Pain Rating Scale > 4)
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by Imperial College of Science, Technology and Medicine and funded by NIHR Imperial Biomedical Research Centre; Medical Research Council (MRC); Innovate UK; Wellcome Trust; .
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for Trial ID: CPMS 62804
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