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

Completed · Not applicable

Conditions studied: Pareses, Lower Extremity

In brief

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

Key facts

Study ID: NCT03906656
Run by: Otto Bock Healthcare Products GmbH
People needed: 149
Starts: 2019-03-11
Expected to finish: 2022-08-23
Last updated by the study team: 2024-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Hanger Clinic — Sarasota, Florida, United States
Scheck & Siress — Chicago, Illinois, United States
Hanger Clinic — Houston, Texas, United States
Hanger Clinic — Seattle, Washington, United States
Orthopädisches Spital Speising Speisingerstraße 109 — Vienna, Austria
BeMoveD - Berlin Movement Diagnostics — Berlin, Deutschland, Germany
Katholisches Klinikum Koblenz-Montabaur — Koblenz, Rhineland-Palatinate, Germany
Johannesbad Raupennest GmbH & Co. KG — Altenberg, Germany
Zentrum für Healthcare Technology der Privaten Hochschule Göttingen — Göttingen, Germany
BG Klinikum Hamburg gGmbH Zentrum für Rehabilitationsmedizin — Hamburg, Germany
Universitätsklinikum Heidelberg, Zentrum für Orthopädie, Unfallchirurgie und Paraplegiologie — Heidelberg, Germany
Pohlig GmbH — Traunstein, Germany
Adelante Kenniscentrum — Hoensbroek, Limburg, Netherlands

Full record on ClinicalTrials.gov

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