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

NCT03906656 | Completed Results

• 1 other identifier: PS00120016A-001
• Study Type: interventional
• Target: 149
• Locations: 4 countries
• Sites: 13

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

Conditions

Pareses, Lower Extremity

Outcome Measures

Primary Outcomes (1)

• Primary Efficacy: Berg Balance Scale (BBS)

  The Berg Balance Scale is a 14-item scale designed to measure static and dynamic balance in adults in a clinical setting. The range in score for the BBS is 0 to 56, with higher scores indicating better balance. Points for each item are deducted if the time or distance requirements are not met, the patient's performance requires supervision, or the patient requires assistance from support or examiner.

  Baseline, 3 months after initial home use period, and 3 months after cross-over home use period

Secondary Outcomes (14)

• Activity-specific Balance Confidence (ABC) Scale

  Baseline, 3 months after initial home use period, and 3 months after cross-over home use period

• Dynamic Gait Index (DGI)

  Baseline, 3 months after initial home use period, and 3 months after cross-over home use period

• 6-minute Walk Test

  Baseline, 3 months after initial home use period, and 3 months after cross-over home use period

• Stair Assessment Index (SAI) - Down

  Baseline, 3 months after initial home use period, and 3 months after cross-over home use period

• Frequency of Falling

  Baseline, 3 months after initial home use period, and 3 months after cross-over home use period

Study Arms (2)

KAFO/SCO

ACTIVE COMPARATOR

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

Device: KAFO/SCO

C-Brace

EXPERIMENTAL

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

Device: C-Brace

Interventions

C-Brace 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.

Also known as: Microprocessor-controlled Stance and Swing Orthosis (MP-SSCO)

C-Brace

KAFO/SCO DEVICE

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

Also known as: Locked KAFO, Posterior offset KAFO, Stance Control Orthosis

KAFO/SCO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Otto Bock Healthcare Products GmbH: lead

Study Sites (13)

Hanger Clinic

Sarasota, Florida, 34233, United States

Location

Scheck & Siress

Chicago, Illinois, 60657, United States

Location

Hanger Clinic

Houston, Texas, 77025, United States

Location

Hanger Clinic

Seattle, Washington, 98116, United States

Location

Orthopädisches Spital Speising Speisingerstraße 109

Vienna, Austria

Location

BeMoveD - Berlin Movement Diagnostics

Berlin, Deutschland, 10117, Germany

Location

Katholisches Klinikum Koblenz-Montabaur

Koblenz, Rhineland-Palatinate, 56073, Germany

Location

Johannesbad Raupennest GmbH & Co. KG

Altenberg, 01773, Germany

Location

Zentrum für Healthcare Technology der Privaten Hochschule Göttingen

Göttingen, 37073, Germany

Location

BG Klinikum Hamburg gGmbH Zentrum für Rehabilitationsmedizin

Hamburg, 21033, Germany

Location

Universitätsklinikum Heidelberg, Zentrum für Orthopädie, Unfallchirurgie und Paraplegiologie

Heidelberg, 69118, Germany

Location

Pohlig GmbH

Traunstein, 83278, Germany

Location

Adelante Kenniscentrum

Hoensbroek, Limburg, 6432 CC, Netherlands

Location

MeSH Terms

Conditions

Paresis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study was affected by the COVID pandemic. Home-use periods interrupted by the pandemic were restarted, and the study was re-opened for enrollment of another 59 subjects. Neither the subjects nor investigators were blinded for interventions. Only subjects with impaired balance (BBS\<45) were included. It is unclear whether the amount of device training was sufficient.

Results Point of Contact

• Title: Russ Lundstrom
• Organization: Ottobock

russ.lundstrom@ottobock.com

6127182025

Study Officials

• Frank Braatz, Dr. med.

  Zentrum für Healthcare Technology der Privaten Hochschule Göttingen

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective international multi-center, open-labeled randomized, controlled cross-over trial

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 8, 2019
• Study Start: March 11, 2019
• Primary Completion: August 23, 2022
• Study Completion: August 23, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); AU (1); DE (7); NL (1)