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C-BRACE Versus SCO in Community Ambulators

Primary Purpose

Lower Limb, Pareses

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
C-BRACE
SCO
Sponsored by
Otto Bock France SNC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lower Limb focused on measuring Knee-ankle-foot orthosis, KAFO

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CRF Korian Le Mont Veyrier
  • Centre Jacques Calvé Fondation Hopale
  • HIA Percy
  • Pôle de Réadaptation de Cornouaille
  • Centre Hospitalier Dieppe
  • Hôpital Raymond-Poincaré
  • Hia Laveran
  • IRR Louis Pierquin
  • CRRF La Chataigneraie
  • CRRF Léopold Bellan
  • Centre Bouffard Vercelli
  • CRRF La Tourmaline
  • CRF Salies de Béarn
  • LADAPT Thionis
  • Chu Rangueil
  • IRMA Institut Robert Merle d'Aubigné
  • PFH Private Hochschule Göttingen
  • Katholisches Klinikum Koblenz-Montabaur

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

C-BRACE/SCO

SCO/C-BRACE

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

PLUS-M™ - Mobility
12-items Self-reported measure of mobility as the ability to move intentionally and independently from one place to another.

Secondary Outcome Measures

6 minutes walk test
Distance walked in 6 minutes
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.
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).
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).
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.
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.

Full Information

First Posted
April 11, 2022
Last Updated
June 22, 2023
Sponsor
Otto Bock France SNC
Collaborators
EVAMED
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1. Study Identification

Unique Protocol Identification Number
NCT05332509
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 19, 2022 (Actual)
Primary Completion Date
April 17, 2023 (Actual)
Study Completion Date
April 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otto Bock France SNC
Collaborators
EVAMED

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Limb, Pareses
Keywords
Knee-ankle-foot orthosis, KAFO

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
C-BRACE/SCO
Arm Type
Experimental
Arm Description
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).
Arm Title
SCO/C-BRACE
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
C-BRACE
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
SCO
Intervention Description
The SCO is a custom made Knee-Ankle-Foot-Orthosis with a knee-joint locked during stance phase and released during swing phase.
Primary Outcome Measure Information:
Title
PLUS-M™ - Mobility
Description
12-items Self-reported measure of mobility as the ability to move intentionally and independently from one place to another.
Time Frame
2-months
Secondary Outcome Measure Information:
Title
6 minutes walk test
Description
Distance walked in 6 minutes
Time Frame
2-months
Title
ABC-s Activities-specific Balance Confidence - simplified
Description
15-items self-reported measure of the perceived balance confidence an individual has while completing various ambulatory activities on 4-levels scale.
Time Frame
2-months
Title
PSFS - Patient Specific Functional Scale
Description
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).
Time Frame
2-months
Title
PIADS - Psychosocial Impact of Assistive Devices Scale
Description
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).
Time Frame
2-months
Title
EQ-5D-5L - Quality of Life
Description
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.
Time Frame
2-months
Title
QUEST 2.0 - Satisfaction
Description
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.
Time Frame
2-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François GENET, Prof. med
Organizational Affiliation
CHU Raymond Poincaré Garches France
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Frank BRAATZ, Prof. med
Organizational Affiliation
PFH Private Hochschule Göttingen Germany
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Axel RUETZ, Dr. med.
Organizational Affiliation
Katholisches Klinikum Koblenz-Montabaur Germany
Official's Role
Study Chair
Facility Information:
Facility Name
CRF Korian Le Mont Veyrier
City
Argonay
Country
France
Facility Name
Centre Jacques Calvé Fondation Hopale
City
Berck
Country
France
Facility Name
HIA Percy
City
Clamart
Country
France
Facility Name
Pôle de Réadaptation de Cornouaille
City
Concarneau
Country
France
Facility Name
Centre Hospitalier Dieppe
City
Dieppe
Country
France
Facility Name
Hôpital Raymond-Poincaré
City
Garches
Country
France
Facility Name
Hia Laveran
City
Marseille
Country
France
Facility Name
IRR Louis Pierquin
City
Nancy
Country
France
Facility Name
CRRF La Chataigneraie
City
Paris
Country
France
Facility Name
CRRF Léopold Bellan
City
Paris
Country
France
Facility Name
Centre Bouffard Vercelli
City
Perpignan
Country
France
Facility Name
CRRF La Tourmaline
City
Saint-Herblain
Country
France
Facility Name
CRF Salies de Béarn
City
Salies-de-Béarn
Country
France
Facility Name
LADAPT Thionis
City
Thionville
Country
France
Facility Name
Chu Rangueil
City
Toulouse
Country
France
Facility Name
IRMA Institut Robert Merle d'Aubigné
City
Valenton
Country
France
Facility Name
PFH Private Hochschule Göttingen
City
Göttingen
Country
Germany
Facility Name
Katholisches Klinikum Koblenz-Montabaur
City
Koblenz
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32976844
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.
Results Reference
background
PubMed Identifier
30965157
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.
Results Reference
background
PubMed Identifier
9256870
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.
Results Reference
background
PubMed Identifier
12206579
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.
Results Reference
background
PubMed Identifier
24812254
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.
Results Reference
background
PubMed Identifier
27151648
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.
Results Reference
background
PubMed Identifier
25249381
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.
Results Reference
background
PubMed Identifier
17466738
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.
Results Reference
background
PubMed Identifier
31912325
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.
Results Reference
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C-BRACE Versus SCO in Community Ambulators

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