Clinical trial NCT05332509: C-BRACE Versus SCO in Community Ambulators
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Limb
Pareses
Keywords: Knee-ankle-foot orthosis
KAFO
Lead sponsor: Otto Bock France SNC
Sponsor class: INDUSTRY
Collaborators: name: EVAMED
First posted: 2022-04-18
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: PLUS-M™ - Mobility
timeFrame: 2-months
Secondary outcomes:
measure: 6 minutes walk test
timeFrame: 2-months
measure: ABC-s Activities-specific Balance Confidence - simplified
timeFrame: 2-months
measure: PSFS - Patient Specific Functional Scale
timeFrame: 2-months
measure: PIADS - Psychosocial Impact of Assistive Devices Scale
timeFrame: 2-months
measure: EQ-5D-5L - Quality of Life
timeFrame: 2-months
measure: QUEST 2.0 - Satisfaction
timeFrame: 2-months
Other outcomes:
Locations:
city: Argonay
country: France
facility: CRF Korian Le Mont Veyrier
city: Berck
country: France
facility: Centre Jacques Calvé Fondation Hopale
city: Clamart
country: France
facility: HIA Percy
city: Concarneau
country: France
facility: Pôle de Réadaptation de Cornouaille
city: Dieppe
country: France
facility: Centre Hospitalier Dieppe
city: Garches
country: France
facility: Hôpital Raymond-Poincaré
city: Marseille
country: France
facility: Hia Laveran
city: Nancy
country: France
facility: IRR Louis Pierquin
city: Paris
country: France
facility: CRRF La Chataigneraie
city: Paris
country: France
facility: CRRF Léopold Bellan
city: Perpignan
country: France
facility: Centre Bouffard Vercelli
city: Saint-Herblain
country: France
facility: CRRF La Tourmaline
city: Salies-de-Béarn
country: France
facility: CRF Salies de Béarn
city: Thionville
country: France
facility: LADAPT Thionis
city: Toulouse
country: France
facility: Chu Rangueil
city: Valenton
country: France
facility: IRMA Institut Robert Merle d'Aubigné
city: Göttingen
country: Germany
facility: PFH Private Hochschule Göttingen
city: Koblenz
country: Germany
facility: Katholisches Klinikum Koblenz-Montabaur
Study officials:
affiliation: CHU Raymond Poincaré Garches France
name: François GENET, Prof. med
role: STUDY_CHAIR
affiliation: PFH Private Hochschule Göttingen Germany
name: Frank BRAATZ, Prof. med
role: STUDY_CHAIR
affiliation: Katholisches Klinikum Koblenz-Montabaur Germany
name: Axel RUETZ, Dr. med.
role: STUDY_CHAIR
References:
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.