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 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT03906656
Eligibility Criteria:
Inclusion Criteria:
* Patient has been tested with the Trial Tool (DTO) and demonstrated the potential to utilize the C-Brace successfully
* Patient has a BBS score \< 45
* Lower limb functional impairment according to CE label wording
* Prior active and compliant use of unilateral or bilateral KAFO or SCO in the past 3 months prior to enrollment in the study
* Patient meets minimum physical requirements to be fitted with a C-Brace, such as muscle status, joint mobility, leg axis and proper control of the orthosis must be guaranteed.
* The User must fulfill the physical and mental requirements for perceiving optical/acoustic signals and/or mechanical vibrations
* The existing muscle strength of the hip extensors and flexors must permit the controlled swing-through of the limb (compensation using the hip is possible).
* Patient´s commitment to use C-Brace 2 at least 1-2 hours per day 5 days per week-
* Patient is ≥ 18 years old
* Patient is willing and able to independently provide informed consent.
* Person is willing to comply with study procedures
Exclusion Criteria:
* Patient who is not able to follow the entire study visits or is unwilling/unable to follow the instructions
* Patient was not able to use DTO
* Patient who is not using an orthosis at least 1 to 2 hours/ day for 5 days per week
* Patient with body weight \> 125 kg (includes body weight and heaviest object (weight) carried)
* Patient with Orthoprosthesis
* Patient with flexion contracture in the knee and/or hip joint in excess of 10°
* Patient with uncontrolled moderate to severe spasticity (relative contraindication moderate spasticity)
* Leg length discrepancy in excess of 15 cm
* Patient with unstable neurological or cardiovascular/pulmonary disease, cancer
* Pregnancy
* Patient using a C-Brace
* Patient with known vertigo or with history of falls unrelated to orthosis use or unrelated to motor disability
* Patient who has never been fitted an orthosis before
* Patient is not able to answer the self-administered questionnaires independently; for patients with upper extremity impairment is it allowed to verbally answer the questions.
* Patient participating already in a study during this study´s duration
* Patient participated in earlier C-Brace studies
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03906656
Study Brief:
Protocol Section:
NCT03906656