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:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT05729633
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of stroke as evidenced by CT/MRI findings
2. First-ever stroke (ischaemic or haemorrhagic)
3. Upper limb weakness and an FMA-UE score of 16-53 (severe to moderate: 16-34. moderate to mild: 35-53)12,13
4. Cognitively intact to follow instructions
5. Medically stable to participate
6. Consent given
7. Age 21 and above (investigating adult stroke patients)
Exclusion Criteria:
1. Fractures or other musculoskeletal issues that render the use of the robotic device unsuitable
2. Involvement in another concurrent upper limb study
3. Wounds that do not allow donning of the device
4. Severe spasticity
5. Cognitive impairment (MMSE ≤20)
6. Inability to follow instructions
7. Severe osteoporosis
8. Infectious diseases
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
99 Years
Study:
NCT05729633
Study Brief:
Protocol Section:
NCT05729633