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 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT03205527
Eligibility Criteria:
Inclusion Criteria:
* Subjects will have to be ambulatory (with or without assistive device) with self-reported chronic (\> 6 months) stroke-induced hemiparesis confirmed by participants' physician and medically cleared. Evidence of unilateral brain lesion confirmed by an imaging study (e.g. CT or MRI).
* Subjects with no other acute and significant neurological, cardiopulmonary, musculoskeletal or systemic diagnosis or have undergone a recent major surgery (\<6 months) or hospitalization (\<3 months) and not on any sedative drugs
* Ability to walk at least 10m with or without assistive device which includes use of ankle orthosis or functional electrical stimulation devices (which is equivalent to having a score of\> 4, dependent supervision on Functional Ambulatory category scale)
Exclusion Criteria:
* Severe osteoporosis (Ultrasound score \< -2)
* Cognitive impairment (Mini Mental State Exam score\<25)
* Aphasia (\<71% on Mississippi Aphasia Screening Test)
* Severe depression ( \> 15 on Geriatric Depression Scale)
* Severe obesity (BMI \>35Kilogram/m2)
* Complains of shortness of breath, or uncontrolled pain (\> 3/10 on VAS), or if pulse oxygen drops \<92% on the 6 minute walk test (for endurance)
* Uncontrolled hypertension (resting systolic blood pressure \> 165 mmHg and/or diastolic blood pressure \> 110mmHg)
* Resting heart rate \> 85% of age-predicted maximal heart rate
* Resting oxygen saturation \<95%
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT03205527
Study Brief:
Protocol Section:
NCT03205527