Clinical Trial Comparing C-Brace to Knee Ankle Foot Orthosis (KAFO)/Stance Control Orthosis (SCO)

Multinational Randomized Controlled Cross-over Trial Comparing C -Brace to Conventional Knee Ankle Foot Orthoses With Respect to Balance, Fall Risk and Activities of Daily Living

Prospective, international, multi-center, open-labeled, randomized, controlled cross-over trial to evaluate effectiveness and benefits in patients with lower limb impairment in activities of daily living comparing the C-Brace microprocessor-controlled stance and swing orthosis to standard of care use of knee ankle foot orthosis/stance control orthoses

After obtaining informed consent, patients will be screened. For subjects fulfilling inclusion/exclusion criteria, a first baseline assessment will be conducted. Within one to two days, a second set of baseline data will be collected for performance measures. Subjects will then be randomly assigned to be fitted with C-Brace or to continue wearing the current KAFO/SCO. After fitting, an accommodation period follows that will last up to 14 days prior to the initial home use. The first follow-up data collection will occur after three months of the initial home use period. Afterwards, the patients will cross over to KAFO/SCO or C-Brace, respectively. The participants who were fitted with C-Brace will cross over to KAFO/SCO and vice versa. Another accommodation phase will be offered for both C-Brace and KAFO/SCO wearers to ensure that subjects can properly use both devices before the cross-over home use period. The second follow-up data collection will occur after 3-months of the cross-over home use period. At the end of the study, the patients can choose to keep the C-Brace for up to 24 months until reimbursement or to return to their original KAFO/SCO.

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