C-BRACE Versus SCO in Community Ambulators

Lower Limb Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05332509
• Other study ID #: BP-11-PT007
• Secondary ID: 2022-A00116-37
• Status: Completed
• Phase: N/A
• Start date: April 19, 2022
• Est. completion date: April 17, 2023

Study information

• Verified date: June 2023
• Source: Otto Bock France SNC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 17, 2023
• Est. primary completion date: April 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lower Limb
• Pareses
• Paresis

Intervention

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.
• SCO
The SCO is a custom made Knee-Ankle-Foot-Orthosis with a knee-joint locked during stance phase and released during swing phase.

Locations

Country	Name	City	State
France	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
Germany	PFH Private Hochschule Göttingen	Göttingen
Germany	Katholisches Klinikum Koblenz-Montabaur	Koblenz

Sponsors (2)

Lead Sponsor	Collaborator
Otto Bock France SNC	EVAMED

Countries where clinical trial is conducted

France,  Germany, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 minutes walk test	Distance walked in 6 minutes	2-months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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