C-BRACE Versus SCO in Community Ambulators

Study Overview
=================
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.

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

Conditions
-----------------
Lower Limb, Pareses

Intervention / Treatment
-----------------
* Device: C-BRACE
* Device: SCO


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C-BRACE/SCO<br>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-BRACE<br>* 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.<br>Device: SCO<br>* The SCO is a custom made Knee-Ankle-Foot-Orthosis with a knee-joint locked during stance phase and released during swing phase.<br>|
| Other: SCO/C-BRACE<br>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-BRACE<br>* 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.<br>Device: SCO<br>* The SCO is a custom made Knee-Ankle-Foot-Orthosis with a knee-joint locked during stance phase and released during swing phase.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minutes walk test | Distance walked in 6 minutes | 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. | 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). | 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). | 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. | 2-months | 
| 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. | 2-months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knee-ankle-foot orthosis, KAFO