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 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
NCT ID:
NCT02114450
Eligibility Criteria:
Inclusion Criteria:
* Sub-acute or chronic stroke i.e., interval of at least 3 months or interval of at least 6 months from stroke to time of enrollment, respectively;
* Cognitive ability to assimilate and participate actively in the treatment protocol (Mini Mental State Examination score \> 24 points, out of a total 30 indicating normal cognitive ability);
* Modified Rankin scale scores 2-4 (Mild-Moderate functional disability post-stroke);
* Modified Ashworth Scale of Spasticity score \<= 2 (ranges from 0-4 with 4 reflecting maximum spasticity);
* Have no skin integrity issues;
* Sufficient passive range of motion at the hip (at least 90 deg flexion, 15-20 deg extension), knee (90 deg flexion, complete extension) and ankle (15 deg dorsiflexion, 15 deg plantarflexion);
* Have no contraindications to standing or walking; able to stand with assistive device for at least 5 minutes, and able to walk with assistive device for 10 m.
Exclusion Criteria:
* Severe cognitive and/or visual deficit;
* Hemineglect (determined based on medical record or initial clinical assessment);
* Severe sensory deficit;
* Joint contractures of any extremity that limits normal range of motion during ambulation with assistive devices;
* Skin lesions that may hinder or prevent the application of exoskeleton;
* Uncontrolled angina;
* Severe chronic obstructive pulmonary disease;
* Other medical contraindications; any medical co-morbidities that would prevent standard rehabilitation.
Inclusion criteria for healthy, able-bodied participants:
* Able to understand and sign the consent form
* Age 18-75 years
Exclusion criteria for healthy, able-bodied participants:
\- History of neurological, neuromuscular or physical disability.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02114450
Study Brief:
Protocol Section:
NCT02114450