Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2022-04-19
2023-04-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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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).
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.
SCO
The SCO is a custom made Knee-Ankle-Foot-Orthosis with a knee-joint locked during stance phase and released during swing phase.
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.
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.
SCO
The SCO is a custom made Knee-Ankle-Foot-Orthosis with a knee-joint locked during stance phase and released during swing phase.
Interventions
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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.
SCO
The SCO is a custom made Knee-Ankle-Foot-Orthosis with a knee-joint locked during stance phase and released during swing phase.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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EVAMED
OTHER
Otto Bock France SNC
INDUSTRY
Responsible Party
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Principal Investigators
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François GENET, Prof. med
Role: STUDY_CHAIR
CHU Raymond Poincaré Garches France
Frank BRAATZ, Prof. med
Role: STUDY_CHAIR
PFH Private Hochschule Göttingen Germany
Axel RUETZ, Dr. med.
Role: STUDY_CHAIR
Katholisches Klinikum Koblenz-Montabaur Germany
Locations
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CRF Korian Le Mont Veyrier
Argonay, , France
Centre Jacques Calvé Fondation Hopale
Berck, , France
HIA Percy
Clamart, , France
Pôle de Réadaptation de Cornouaille
Concarneau, , France
Centre Hospitalier Dieppe
Dieppe, , France
Hôpital Raymond-Poincaré
Garches, , France
Hia Laveran
Marseille, , France
IRR Louis Pierquin
Nancy, , France
CRRF La Chataigneraie
Paris, , France
CRRF Léopold Bellan
Paris, , France
Centre Bouffard Vercelli
Perpignan, , France
CRRF La Tourmaline
Saint-Herblain, , France
CRF Salies de Béarn
Salies-de-Béarn, , France
LADAPT Thionis
Thionville, , France
Chu Rangueil
Toulouse, , France
IRMA Institut Robert Merle d'Aubigné
Valenton, , France
PFH Private Hochschule Göttingen
Göttingen, , Germany
Katholisches Klinikum Koblenz-Montabaur
Koblenz, , Germany
Countries
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References
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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.
Other Identifiers
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2022-A00116-37
Identifier Type: OTHER
Identifier Source: secondary_id
BP-11-PT007
Identifier Type: -
Identifier Source: org_study_id
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