NCT05332509

C-BRACE Versus SCO in Community Ambulators

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Otto Bock France SNC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lower Limb
• Pareses

Interventions

Type	Name	Description
DEVICE	C-BRACE	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.
DEVICE	SCO	The SCO is a custom made Knee-Ankle-Foot-Orthosis with a knee-joint locked during stance phase and released during swing phase.

Timeline

• Start date: 2022-04-19
• Primary completion: 2023-04-17
• Completion: 2023-04-17
• First posted: 2022-04-18
• Last updated: 2023-06-23

Locations

18 sites across 2 countries: France, Germany