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Lower LimbNCT05332509

C-BRACE Versus SCO in Community Ambulators

A study testing C-BRACE and SCO in people with Lower Limb and Pareses, run by Otto Bock France SNC at 18 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lower Limb, Pareses
What is being tested?
C-BRACE and SCO
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
18 sitesin 2 countries
Study dates
19 Apr 2022to 17 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

18 sites in 2 countries.

18 sites in 2 countries

France16 sites

  • CRF Korian Le Mont Veyrier

    Argonay

  • Centre Jacques Calvé Fondation Hopale

    Berck

  • HIA Percy

    Clamart

  • Pôle de Réadaptation de Cornouaille

    Concarneau

  • Centre Hospitalier Dieppe

    Dieppe

  • Hôpital Raymond-Poincaré

    Garches

  • Hia Laveran

    Marseille

  • IRR Louis Pierquin

    Nancy

  • CRRF La Chataigneraie

    Paris

  • CRRF Léopold Bellan

    Paris

  • Centre Bouffard Vercelli

    Perpignan

  • CRRF La Tourmaline

    Saint-Herblain

  • CRF Salies de Béarn

    Salies-de-Béarn

  • LADAPT Thionis

    Thionville

  • Chu Rangueil

    Toulouse

  • IRMA Institut Robert Merle d'Aubigné

    Valenton

Other trials in France

Germany2 sites

  • PFH Private Hochschule Göttingen

    Göttingen

  • Katholisches Klinikum Koblenz-Montabaur

    Koblenz

Other trials in Germany

About this study

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

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.

Read the 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.

Conditions
Lower Limb, Pareses
Being tested
C-BRACE, SCO
Keywords
Knee-ankle-foot orthosis, KAFO
Medical subject headings
Paresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • SCODevice

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

Study groups in NCT05332509
Study groupRoleWhat they receive
C-BRACE/SCOExperimentalThe 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).
Receives: Device: C-BRACE; Device: SCO
SCO/C-BRACEOtherThe 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.
Receives: Device: C-BRACE; Device: SCO

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PLUS-M™ - Mobility

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

    Measured: 2-months

Secondary outcomes (6)

  1. 6 minutes walk test

    Distance walked in 6 minutes

    Measured: 2-months

  2. 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.

    Measured: 2-months

  3. 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).

    Measured: 2-months

  4. 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).

    Measured: 2-months

  5. 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.

    Measured: 2-months

  6. 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.

    Measured: 2-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2022
  2. Study start19 Apr 2022
  3. Primary completion17 Apr 2023
  4. Study completion17 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05332509
Sponsor's protocol ID
BP-11-PT007
Other IDs
2022-A00116-37
Status last verified
Jun 2023
First submitted
11 Apr 2022
Last updated
23 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32976844

  • 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.

    PubMed 30965157

  • 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.

    PubMed 9256870

  • 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.

    PubMed 12206579

  • 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.

    PubMed 24812254

  • 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.

    PubMed 27151648

  • 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.

    PubMed 25249381

  • 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.

    PubMed 17466738

  • 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.

    PubMed 31912325

Questions about this trial

What is this clinical trial studying?

A study testing C-BRACE and SCO in people with Lower Limb and Pareses, run by Otto Bock France SNC at 18 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PLUS-M™ - Mobility (time frame: 2-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05332509, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.

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