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 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT05849532
Eligibility Criteria:
Inclusion Criteria:
1. Age group: 18-90 years.
2. Presence of unilateral hemiparesis.
3. Onset of stroke (\> 6 months).
4. Ability to walk independently with or without an assistive device for at least 300 ft.
5. Can understand and communicate in English and can verbalize discomfort or pain in English
6. Use of smartphone on a daily basis
7. Availability of internet/Wi-Fi at home
Exclusion Criteria:
1. Body weight more than 250 lbs.
2. Heel bone density measurement using an ultrasound device. Individuals classified as osteoporotic (i.e., with a T-score \< -2) will be excluded.
3. Cognitive impairment (Montreal Cognitive assessment score \<26/30)
4. Verbal Aphasia (i.e \<71% score on Mississippi Aphasia Screening)
5. Severe depression (\> 15 points on geriatric depression scale)
6. Any neurological condition other than stroke.
7. Uncontrolled and/or untreated hypertension/hypotension, uncontrolled and/or untreated diabetes and any musculoskeletal, neuromuscular or systemic diagnosis .
8. Recent major surgery (\< 6 months) or hospitalization (\< 3 months).
9. Deep venous thrombosis.
10. Past or current history of any type of active cancer
11. Peripheral nerve injury or neuropathy in the affected limb with motor disability.
12. Uncontrolled high blood pressure/angina.
13. Skin condition not tolerant with FES therapy.
14. Past or current history of uncontrolled/controlled epilepsy or any other types of seizure disorders
15. Botox treatment within the last 5 months.
16. Pacemaker users.
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT05849532
Study Brief:
Protocol Section:
NCT05849532