NCT05332509

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
2 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 18, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

April 19, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2023

Completed
Last Updated

June 23, 2023

Status Verified

June 1, 2023

Enrollment Period

12 months

First QC Date

April 11, 2022

Last Update Submit

June 22, 2023

Conditions

Lower LimbPareses

Keywords

Knee-ankle-foot orthosisKAFO

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 6 minutes walk test

    2-months

  • ABC-s Activities-specific Balance Confidence - simplified

    2-months

  • PSFS - Patient Specific Functional Scale

    2-months

  • PIADS - Psychosocial Impact of Assistive Devices Scale

    2-months

  • EQ-5D-5L - Quality of Life

    2-months

  • +1 more secondary outcomes

Study Arms (2)

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).

Device: C-BRACEDevice: SCO

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.

Device: C-BRACEDevice: SCO

Interventions

C-BRACEDEVICE

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.

C-BRACE/SCOSCO/C-BRACE
SCODEVICE

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

C-BRACE/SCOSCO/C-BRACE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

CRF Korian Le Mont Veyrier

Argonay, France

Location

Centre Jacques Calvé Fondation Hopale

Berck, France

Location

HIA Percy

Clamart, France

Location

Pôle de Réadaptation de Cornouaille

Concarneau, France

Location

Centre Hospitalier Dieppe

Dieppe, France

Location

Hôpital Raymond-Poincaré

Garches, France

Location

Hia Laveran

Marseille, France

Location

IRR Louis Pierquin

Nancy, France

Location

CRRF La Chataigneraie

Paris, France

Location

CRRF Léopold Bellan

Paris, France

Location

Centre Bouffard Vercelli

Perpignan, France

Location

CRRF La Tourmaline

Saint-Herblain, France

Location

CRF Salies de Béarn

Salies-de-Béarn, France

Location

LADAPT Thionis

Thionville, France

Location

Chu Rangueil

Toulouse, France

Location

IRMA Institut Robert Merle d'Aubigné

Valenton, France

Location

PFH Private Hochschule Göttingen

Göttingen, Germany

Location

Katholisches Klinikum Koblenz-Montabaur

Koblenz, Germany

Location

Related Publications (9)

  • 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.

    PMID: 32976844BACKGROUND

  • 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.

    PMID: 30965157BACKGROUND

  • 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.

    PMID: 9256870BACKGROUND

  • 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.

    PMID: 12206579BACKGROUND

  • 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.

    PMID: 24812254BACKGROUND

  • 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.

    PMID: 27151648BACKGROUND

  • 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.

    PMID: 25249381BACKGROUND

  • 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.

    PMID: 17466738BACKGROUND

  • 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.

    PMID: 31912325BACKGROUND

MeSH Terms

Conditions

Paresis

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2022

First Posted

April 18, 2022

Study Start

April 19, 2022

Primary Completion

April 17, 2023

Study Completion

April 17, 2023

Last Updated

June 23, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(16)DE(2)