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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A00116-37 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| EVAMED | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C-BRACE/SCO | Experimental | 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). |
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| SCO/C-BRACE | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C-BRACE | Device | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRF Korian Le Mont Veyrier | Argonay | France | ||||
| Centre Jacques Calvé Fondation Hopale |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32976844 | Background | 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. | |
| 30965157 | Background |
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| ID | Term |
|---|---|
| D010291 | Paresis |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| SCO | Device | The SCO is a custom made Knee-Ankle-Foot-Orthosis with a knee-joint locked during stance phase and released during swing phase. |
|
| 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 |
| 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 |
| 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. |
| 9256870 | Background | 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. |
| 12206579 | Background | 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. |
| 24812254 | Background | 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. |
| 27151648 | Background | 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. |
| 25249381 | Background | 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. |
| 17466738 | Background | 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. |
| 31912325 | Background | 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. |