Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2025-12-24 @ 3:41 PM
NCT ID:
NCT04475692
Eligibility Criteria:
Inclusion Criteria:
* 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/if appropriate. Easy read patient information sheet (PIS) and training materials will be implemented to support patients presenting with specific cognitive and/or communication needs.
* Stroke diagnosis (can be first or subsequent stroke, unilateral haemorrhagic or ischemic) 4 weeks max post stroke at time of recruitment.
* Can communicate in English, that is, sufficient for completion of intervention and outcome measures. It is advisable that a decision to include or exclude those with significant expressive or receptive communication impairment should be made following consultation with the treating speech and language therapist (SLT) 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) or voluntary finger extension of the thumb and/or two or more fingers of the affected hand (to 10° or more). The presence of sensory impairment (including neglect syndrome) or movement disorder (apraxia) is not a contraindication to enrolment as long as there is a concurrent motor deficit (as described above).
Exclusion Criteria:
* 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).
* Patients with uncontrolled photosensitive epilepsy/Other neurological symptoms that may be exacerbated by required focus on light emitting diode (LED) screen/moving object on screen).
* Those registered blind/with uncompensated/uncorrected visual deficits.
* 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 pain at rest.
* Pre-existing UL impairment with known and significant disruption to range of motion, motor or functional performance (fracture, arthritic changes, other known musculoskeletal problems).
* 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04475692
Study Brief:
Protocol Section:
NCT04475692