C-Brace Prospective Registry

Conditions

• Lower Extremity
• Pareses

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• C-Brace — DEVICE
  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.

Study Details

To gather prospective safety and effectiveness data for the C-Brace System following the standard of care.

Key Dates

Start date

Apr 30, 2015

Status verified

Apr 2025

Primary completion

Apr 30, 2026

Completion

Apr 30, 2026

Study Design

Enrollment

250 participants (estimated)

Primary Outcome Measure

Primary Efficacy: Timed Walk Test [ Time Frame: Change in walking speed with the C-Brace measured either by a 25-ft or 10-m walk test compared to baseline measurements when assessed 12 months after initial fitting ]

Central Contacts

• Russell L Lundstrom, MS
  512-806-2606
  [email protected]
• Barbara Pobatschnig, MSc
  +43 1 5233786-720
  [email protected]

Locations (70)

Find similar trials in Harrison, AR

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