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

NCT ID: NCT03906656

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-11
• Study Completion Date: 2022-08-23

Brief 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

Detailed 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.

Conditions

Pareses, Lower Extremity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

KAFO/SCO

Home use of 3 months with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)

Group Type: ACTIVE_COMPARATOR

KAFO/SCO

Intervention Type: DEVICE

Current knee ankle foot orthosis that the subject was wearing at baseline

C-Brace

Home use of 3 months with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.

Group Type: EXPERIMENTAL

C-Brace

Intervention Type: DEVICE

The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.

Interventions

C-Brace

The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.

Intervention Type: DEVICE

KAFO/SCO

Current knee ankle foot orthosis that the subject was wearing at baseline

Intervention Type: DEVICE

Other Intervention Names

Microprocessor-controlled Stance and Swing Orthosis (MP-SSCO); Locked KAFO, Posterior offset KAFO, Stance Control Orthosis

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otto Bock Healthcare Products GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank Braatz, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Zentrum für Healthcare Technology der Privaten Hochschule Göttingen

Locations

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

Countries

United States; Austria; Germany; Netherlands

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PS00120016A-001

Identifier Type: -

Identifier Source: org_study_id