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Completed

NCT Number: NCT05332509

C-BRACE Versus SCO in Community Ambulators

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.

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Key information

Conditions

Lower Limb Nervous System Diseases Neurologic Manifestations Pareses Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CRF Korian Le Mont Veyrier, Argonay, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. PLUS-M™ - Mobility

    Time frame: 2-months

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

Secondary outcomes

  1. 6 minutes walk test

    Time frame: 2-months

    Distance walked in 6 minutes

  2. ABC-s Activities-specific Balance Confidence - simplified

    Time frame: 2-months

    15-items self-reported measure of the perceived balance confidence an individual has while completing various ambulatory activities on 4-levels scale.

  3. PSFS - Patient Specific Functional Scale

    Time frame: 2-months

    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).

  4. PIADS - Psychosocial Impact of Assistive Devices Scale

    Time frame: 2-months

    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).

  5. EQ-5D-5L - Quality of Life

    Time frame: 2-months

    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.

  6. QUEST 2.0 - Satisfaction

    Time frame: 2-months

    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.

Sponsors and collaborators

Lead sponsor

Otto Bock France SNC

Industry

Collaborators

  • EVAMED

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 18, 2022
Registry last updated
Jun 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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