At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multinational Randomized Controlled Cross-over Trial Comparing C -Brace to Conventional Knee Ankle Foot Orthoses With Respect to Balance, Fall Risk and Activities of Daily Living
In Brief
A clinical study evaluating C-Brace and KAFO/SCO for Pareses, Lower Extremity. Completed, enrolled 149 participants across 13 sites in 4 countries.
Detailed Summary
Prospective, international, multi-center, open-labeled, randomized, controlled cross-over trial to evaluate effectiveness and benefits in patients with lower limb impairment in activities of daily living comparing the C-Brace microprocessor-controlled stance and swing orthosis to standard of care use of knee ankle foot orthosis/stance control orthoses
Study Details
Timeline
Interventions
The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.
Current knee ankle foot orthosis that the subject was wearing at baseline