An interventional study of C-BRACE and SCO in Lower Limb and Pareses, sponsored by Otto Bock France SNC. Completed at 18 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-23.
Sponsored by Otto Bock France SNC · Not applicable, Interventional, and Other
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.
519 studies on the registry are indexed under Paresis; 111 are open to participants now.
This study's enrollment of 38 is close to the median of 36 across 448 interventional studies indexed under Paresis.
Browse Paresis studies →Otto Bock France SNC is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Device: 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.
Device: C-BRACE · Device: SCO
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.
The SCO is a custom made Knee-Ankle-Foot-Orthosis with a knee-joint locked during stance phase and released during swing phase.
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
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
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.
Time frame: 2-months
Plan to share: No
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Otto Bock France SNC