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

Otto Bock Healthcare (Ottobock)

Status

Completed

Conditions

Pareses, Lower Extremity

Treatments

Device: C-Brace

Device: KAFO/SCO

Study type

Interventional

Funder types

Industry

Identifiers

NCT03906656

PS00120016A-001

Details and patient eligibility

About

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

Full description

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.

Enrollment

149 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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