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C-BRACE Versus SCO in Community Ambulators

NCT05332509 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2023-06-23

No results posted yet for this study

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.

Conditions

  • Lower Limb
  • Pareses

Interventions

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.

Sponsors & Collaborators

  • EVAMED

    collaborator OTHER

  • Otto Bock France SNC

    lead INDUSTRY

Principal Investigators

  • François GENET, Prof. med · CHU Raymond Poincaré Garches France

  • Frank BRAATZ, Prof. med · PFH Private Hochschule Göttingen Germany

  • Axel RUETZ, Dr. med. · Katholisches Klinikum Koblenz-Montabaur Germany

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-19
Primary Completion
2023-04-17
Completion
2023-04-17

Countries

  • France
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05332509 on ClinicalTrials.gov