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 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT02878759
Eligibility Criteria:
Inclusion Criteria:
* First clinical stroke (ischaemic or haemorrhagic) diagnosed by brain imaging CT or MRI
* Age 21 years to 85 years, both males and females.
* \< 90 days of stroke on admission to rehabilitation
* Presence of either motor and /or sensory deficit detected by clinical examination.
* Ability to understand simple instructions.
* Ability to give own consent.
* Ability to sit supported in a chair for 60 minutes with appropriate rest breaks.
Exclusion Criteria:
* Non stroke -related causes of motor/sensory deficits
* Tetraplegia or tetraparesis
* Known diagnosis of cervical myelopathy, lower motor neuron weakness (Post polio, brachial plexopathy, peripheral neuropathy (Diabetic, carpel tunnel syndrome, B12 deficiency)
* Concomitant orthopaedic condition limiting wrist range of motion: active arm/wrist fractures, fixed contractures of the wrist joint, wrist joint arthritis, wrist fusion.
* Arm or wrist joint pain (Visual Analogue scale VAS \>5/10) or instability
* Severe hemispatial neglect.
* Significant wrist spasticity with modified Ashworth Scale score 2 and above.
* Life expectancy \<6 months, end stage renal or liver disease, terminal cancer.
* Pregnancy and lactation in female patients.
* Postural hypotension on sitting up
* Active skin conditions over wrist joint area which could be worsened by robotic fit (e.g. severe eczema, burns)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
85 Years
Study:
NCT02878759
Study Brief:
Protocol Section:
NCT02878759