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 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT06406569
Eligibility Criteria:
Inclusion Criteria:
1. Clinical stroke (ischaemic or haemorrhagic) confirmed by admitting doctors and CT, CT angiography or MRI brain imaging
2. Age 21 to 80 years, both males and females
3. At least 28 days post-stroke
4. Upper limb motor impairment of Fugl-Meyer Assessment (FMA) scale 20 to 50
5. Montreal Cognitive Assessment (MoCA) \> 21/30
6. Ability to sit supported and continuously for 60 minutes
7. Stable home abode with enough space to place technologies
8. Has a carer/next of kin to supervise home-based exercises
Exclusion Criteria:
1. Functional impairment of the upper limb due to other pathologies
2. Medical conditions incompatible with research participation: uncontrolled medical illnesses (hypertension or diabetes, ischaemic heart disease, congestive heart failure, bronchial asthma, severe /untreated depression, agitation, end stage renal/liver/heart/lung failure, unresolved cancers)
3. Anticipated life expectancy of less than 6 months
4. Pacemakers and other active implants
5. Active seizures within 3 months
6. Local factors potentially worsened by intensive technology-aided upper-limb therapy and computer-based training:
* Spasticity - modified Ashworth Scale MAS \> 2 of any upper limb muscle groups
* Severe pain in affected arm - Visual Analogue Scale for pain VAS \> 5/10
* Skin wounds
7. Cognitive impairment precluding study participation
8. Severe visual impairment or visual neglect affecting ability to use technologies
9. History of dementia, depression or behavioural problems
10. Pregnant or lactating females will not be allowed to participate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT06406569
Study Brief:
Protocol Section:
NCT06406569