C-BRACE Versus SCO in Community Ambulators
- Conditions
- ParesesLower Limb
- Interventions
- Device: C-BRACEDevice: SCO
- Registration Number
- NCT05332509
- Lead Sponsor
- Otto Bock France SNC
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description C-BRACE/SCO C-BRACE 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). SCO/C-BRACE 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. C-BRACE/SCO SCO 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). SCO/C-BRACE C-BRACE 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.
- Primary Outcome Measures
Name Time Method PLUS-M™ - Mobility 2-months 12-items Self-reported measure of mobility as the ability to move intentionally and independently from one place to another.
- Secondary Outcome Measures
Name Time Method ABC-s Activities-specific Balance Confidence - simplified 2-months 15-items self-reported measure of the perceived balance confidence an individual has while completing various ambulatory activities on 4-levels scale.
6 minutes walk test 2-months Distance walked in 6 minutes
PSFS - Patient Specific Functional Scale 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).
PIADS - Psychosocial Impact of Assistive Devices Scale 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).
EQ-5D-5L - Quality of Life 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.
QUEST 2.0 - Satisfaction 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.
Trial Locations
- Locations (18)
Hia Laveran
🇫🇷Marseille, France
CRRF La Chataigneraie
🇫🇷Paris, France
CRRF Léopold Bellan
🇫🇷Paris, France
Centre Bouffard Vercelli
🇫🇷Perpignan, France
Chu Rangueil
🇫🇷Toulouse, France
Katholisches Klinikum Koblenz-Montabaur
🇩🇪Koblenz, Germany
CRRF La Tourmaline
🇫🇷Saint-Herblain, France
CRF Korian Le Mont Veyrier
🇫🇷Argonay, France
Centre Jacques Calvé Fondation Hopale
🇫🇷Berck, France
Hôpital Raymond-Poincaré
🇫🇷Garches, France
Pôle de Réadaptation de Cornouaille
🇫🇷Concarneau, France
Centre Hospitalier Dieppe
🇫🇷Dieppe, France
HIA Percy
🇫🇷Clamart, France
IRR Louis Pierquin
🇫🇷Nancy, France
PFH Private Hochschule Göttingen
🇩🇪Göttingen, Germany
CRF Salies de Béarn
🇫🇷Salies-de-Béarn, France
LADAPT Thionis
🇫🇷Thionville, France
IRMA Institut Robert Merle d'Aubigné
🇫🇷Valenton, France