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 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT06233734
Eligibility Criteria:
Inclusion criteria:
1. Independently mobile (with or without an aid) prior to the stroke
2. FAC (Functional Ambulation Category) score of 0-2 at baseline
3. Cardiovascularly stable as determined by the medical team (heart and blood pressure is stable)
4. Able to tolerate being upright for at least 30 minutes and participate in active therapy
Exclusion criteria:
1. If participants have any contraindications related to Lokomat use, as per the manufacturers (Hocoma) guidance. The contraindications in full can be found on the HOCOMA website (https://www.hocoma.com/legal- notes/#lokomatpro\_lokomatnanos). The most relevant contraindications are:
* Any known diagnosis of low bone mineral density - Over 2 metres tall
* Over 135kg
* Non-consolidated fractures
* Any medical condition preventing active rehabilitation (e.g., respiratory disease, pregnancy, neuropsychological conditions)
* Fixed joint contractures that limit the range of motion of the orthosis - Upper leg length of less than 35cm and more than 47cm
* Any condition or situation which prohibits the proper adjustment of the harness and/or orthosis (e.g., pregnancy, colostomy bags, skin lesions that cannot be protected appropriately).
2. If patients do not have the capacity to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06233734
Study Brief:
Protocol Section:
NCT06233734