C-BRACE Versus SCO in Community Ambulators

Otto Bock France SNC38 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Lower Limb Pareses

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.

SCODEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (18)

CRF Korian Le Mont Veyrier

Argonay, France

Centre Jacques Calvé Fondation Hopale

Berck, France

HIA Percy

Clamart, France

Outcomes

Primary Outcomes

PLUS-M™ - Mobility

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 Outcomes

6 minutes walk test

Distance walked in 6 minutes

Time frame: 2-months

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.

Time frame: 2-months

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).

Time frame: 2-months

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).

Time frame: 2-months

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.

Time frame: 2-months

Data from ClinicalTrials.gov

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