clinical trial comparing c-brace to knee ankle foot orthosis (kafo)/stance control orthosis (sco)

Conditions: Pareses, Lower Extremity

Summary: 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.

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