C-BRACE Versus SCO in Community Ambulators

Mobility and Quality of Life in Community Ambulators With Knee Locking Deficiency Using a Microprocessor Controlled Knee Ankle Foot Orthosis and a Stance Control Orthosis: Randomized Crossover Trial

The purpose of this multicentric study is to assess the impact of C-BRACE on mobility, endurance, confidence, participation, satisfaction, psychosocial adjustment and quality of life in community ambulators using a Stance Control Orthosis.

Study Overview

• Status: Completed
• Conditions: Lower Limb; Pareses
• Intervention / Treatment: Device: C-BRACE; Device: SCO

Detailed Description

During two months of inclusion period, the investigators invite all patients matching with inclusion criteria for an enrolment visit, collect written consent and record general patient information. The eCRF (electronic Case Report Form) assigns the enrolled patient into one group for the trial (C-BRACE/SCO or SCO/C-BRACE), in a randomized order. The assessments are performed after 2 month follow-up period with each orthosis with a minimal wash-out period of 2 weeks.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aurélie LACROIX; Phone Number: +33786295203; Email: aurelie.lacroix@ottobock.com
• Study Contact Backup: Name: Benoit PONSAN; Phone Number: +33605572244; Email: benoit.ponsan@ottobock.com

Study Locations

• France
  • Argonay, France
    • CRF Korian Le Mont Veyrier
  • Berck, France
    • Centre Jacques Calvé Fondation Hopale
    • Principal Investigator: Frédéric CHARLATE, Dr. med.
  • Clamart, France
    • HIA Percy
    • Principal Investigator: Léo BORRINI, Dr. med.
  • Concarneau, France
    • Pôle de Réadaptation de Cornouaille
    • Principal Investigator: Claire DELBROUCK, Dr. med.
  • Dieppe, France
    • Centre Hospitalier Dieppe
    • Principal Investigator: Anaïs BEAUCHER, Dr. med.
  • Garches, France
    • Hôpital Raymond-Poincaré
    • Principal Investigator: François GENET, Prof.
  • Marseille, France
    • Hia Laveran
    • Principal Investigator: Laurent THEFENNE, Prof. med.
  • Nancy, France
    • IRR Louis Pierquin
    • Principal Investigator: Isabelle LOIRET, Dr. med.
  • Paris, France
    • CRRF La Chataigneraie
    • Principal Investigator: Rania BELMAHFOUD, Dr. med.
  • Paris, France
    • CRRF Léopold Bellan
    • Principal Investigator: Frédéric DE LUCAS VASQUEZ, Dr. med.
  • Perpignan, France
    • Centre Bouffard Vercelli
    • Principal Investigator: Vincent MOIZIARD, Dr. med.
  • Saint-Herblain, France
    • CRRF La Tourmaline
    • Principal Investigator: Guillaume BOKOBZA, Dr. med.
  • Salies-de-Béarn, France
    • CRF Salies de Béarn
    • Principal Investigator: Caroline NAVARRE, Dr. med.
  • Thionville, France
    • LADAPT Thionis
    • Principal Investigator: Isabelle NOIZETTE, Dr. med.
  • Toulouse, France
    • CHU Rangueil
    • Principal Investigator: Virgile PINELLI, Dr. med.
  • Valenton, France
    • IRMA Institut Robert Merle d'Aubigné
    • Principal Investigator: Brice LAVRARD, Dr. med.
• Germany
  • Göttingen, Germany
    • PFH Private Hochschule Göttingen
    • Principal Investigator: Frank Braatz, Prof.
  • Koblenz, Germany
    • Katholisches Klinikum Koblenz-Montabaur
    • Principal Investigator: Axel RUETZ, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• person with knee locking deficiency
• person using a SCO (Stance Control Orthosis) for at least three months, walking with a swing phase on a flat ground, without walking aid or with one cane or one crutch.
• person having the ability to walk at 3km/h (measured with 10 meters walk test) with the SCO in unlocked mode.
• person with a stable stance phase on the contralateral side

Exclusion Criteria:

• person with deficient or unstable contralateral knee, including person using a Knee-Ankle Foot Orthosis on the contralateral limb
• person walking using two canes, two crutches, one or two underarm crutches or a walker
• person with health condition not compatible with the study protocol
• person under 18 years old
• person unwilling / unable to follow the entire study protocol / instructions
• person who did not give her written consent to participate to the study or unable to personally give her consent
• person with knee and/or hip flexion contracture >10°
• person with genu varum / valgum > 10° (not reducible)
• person with moderate to severe spasticity
• person with leg length discrepancy > 15cm
• person who necessitate the use of an orthoprosthesis
• person with body weight > 125kg
• person with unstable trunk in standing position
• person with cognitive impairments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: C-BRACE/SCO; The patient is first fitted during 2 months with the C-BRACE orthosis, them, after 2 weeks wash-out period, the patient is fitted with its Stance Controlled Orthosis (SCO).	Device: C-BRACE; The C-BRACE is a custom made Knee-Ankle-Foot-Orthosis with a microprocessor-controlled hydraulic knee-joint articulation. The C-BRACE technology offers to a patient with knee locking deficiencies the following advantages: approximation of the physiological gait pattern, stability while standing and walking, adaptation to various surfaces, inclines, gait situations and walking speeds.; Device: SCO; The SCO is a custom made Knee-Ankle-Foot-Orthosis with a knee-joint locked during stance phase and released during swing phase.
Other: SCO/C-BRACE; The patient is using its Stance controlled orthosis (SCO) during 2 months, then, after 2 weeks wash-out period, the patient is fitted with the C-BRACE orthosis.	Device: C-BRACE; The C-BRACE is a custom made Knee-Ankle-Foot-Orthosis with a microprocessor-controlled hydraulic knee-joint articulation. The C-BRACE technology offers to a patient with knee locking deficiencies the following advantages: approximation of the physiological gait pattern, stability while standing and walking, adaptation to various surfaces, inclines, gait situations and walking speeds.; Device: SCO; The SCO is a custom made Knee-Ankle-Foot-Orthosis with a knee-joint locked during stance phase and released during swing phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PLUS-M™ - Mobility	12-items Self-reported measure of mobility as the ability to move intentionally and independently from one place to another.	2-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 minutes walk test	Distance walked in 6 minutes	2-months
ABC-s Activities-specific Balance Confidence - simplified	15-items self-reported measure of the perceived balance confidence an individual has while completing various ambulatory activities on 4-levels scale.	2-months
PSFS - Patient Specific Functional Scale	Patients will be asked to identify three activities that they are having difficulty or are unable to perform because of their condition. Patients will then be asked to rate their ability to perform each activity on a numerical scale ('0' being unable to perform the activity, and '10' being able to full perform the activity).	2-months
PIADS - Psychosocial Impact of Assistive Devices Scale	26-items questionnaire that assess the effects of an assistive device on functional independence, well-being and quality of life from the person's disability's point of view. Each item is noted on a 7-points Likert scale going from -3 (maximum negative impact) to +3 (maximum positive impact).	2-months
EQ-5D-5L - Quality of Life	Self-reported measure of health status composed of 5 dimensions: mobility, ability to self-care, ability to undertake usual activities, pain and discomfort, anxiety and depression. Each dimension is rated on a 5-point scale.	2-months
QUEST 2.0 - Satisfaction	12-items self-reported measure on patient's satisfaction regarding the technology of the device and the services around the device. It allows the patient to express himself on the 3 most important criteria to him.	2-months

Collaborators and Investigators

• Sponsor: Otto Bock France SNC
• Collaborators: EVAMED
• Investigators: Study Chair: François GENET, Prof. med, CHU Raymond Poincaré Garches France; Study Chair: Frank BRAATZ, Prof. med, PFH Private Hochschule Göttingen Germany; Study Chair: Axel RUETZ, Dr. med., Katholisches Klinikum Koblenz-Montabaur Germany

Publications and helpful links

General Publications

• Deems-Dluhy S, Hoppe-Ludwig S, Mummidisetty CK, Semik P, Heinemann AW, Jayaraman A. Microprocessor Controlled Knee Ankle Foot Orthosis (KAFO) vs Stance Control vs Locked KAFO: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 Feb;102(2):233-244. doi: 10.1016/j.apmr.2020.08.013. Epub 2020 Sep 22.
• Karatzios C, Loiret I, Luthi F, Leger B, Le Carre J, Saubade M, Muff G, Benaim C. Transcultural adaptation and validation of a French version of the Prosthetic Limb Users Survey of Mobility 12-item Short-Form (PLUS-M/FC-12) in active amputees. Ann Phys Rehabil Med. 2019 May;62(3):142-148. doi: 10.1016/j.rehab.2019.02.006. Epub 2019 Apr 6.
• Chatman AB, Hyams SP, Neel JM, Binkley JM, Stratford PW, Schomberg A, Stabler M. The Patient-Specific Functional Scale: measurement properties in patients with knee dysfunction. Phys Ther. 1997 Aug;77(8):820-9. doi: 10.1093/ptj/77.8.820.
• Demers L, Monette M, Descent M, Jutai J, Wolfson C. The Psychosocial Impact of Assistive Devices Scale (PIADS): translation and preliminary psychometric evaluation of a Canadian-French version. Qual Life Res. 2002 Sep;11(6):583-92. doi: 10.1023/a:1016397412708.
• Middleton A, Fritz SL, Lusardi M. Walking speed: the functional vital sign. J Aging Phys Act. 2015 Apr;23(2):314-22. doi: 10.1123/japa.2013-0236. Epub 2014 May 2.
• Probsting E, Kannenberg A, Zacharias B. Safety and walking ability of KAFO users with the C-Brace(R) Orthotronic Mobility System, a new microprocessor stance and swing control orthosis. Prosthet Orthot Int. 2017 Feb;41(1):65-77. doi: 10.1177/0309364616637954. Epub 2016 Jul 10.
• Schmalz T, Probsting E, Auberger R, Siewert G. A functional comparison of conventional knee-ankle-foot orthoses and a microprocessor-controlled leg orthosis system based on biomechanical parameters. Prosthet Orthot Int. 2016 Apr;40(2):277-86. doi: 10.1177/0309364614546524. Epub 2014 Sep 23.
• Filiatrault J, Gauvin L, Fournier M, Parisien M, Robitaille Y, Laforest S, Corriveau H, Richard L. Evidence of the psychometric qualities of a simplified version of the Activities-specific Balance Confidence scale for community-dwelling seniors. Arch Phys Med Rehabil. 2007 May;88(5):664-72. doi: 10.1016/j.apmr.2007.02.003.
• Andrade LF, Ludwig K, Goni JMR, Oppe M, de Pouvourville G. A French Value Set for the EQ-5D-5L. Pharmacoeconomics. 2020 Apr;38(4):413-425. doi: 10.1007/s40273-019-00876-4.

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2022
• Primary Completion (Actual): April 17, 2023
• Study Completion (Actual): April 17, 2023

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: April 15, 2022
• First Posted (Actual): April 18, 2022

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Knee-ankle-foot orthosis; KAFO
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paresis
• Other Study ID Numbers: BP-11-PT007; 2022-A00116-37 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No