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Comparing Functional Outcomes in Individuals Using Micro-processor Controlled Orthosis Versus Stance Control Orthosis

NCT02089880 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-05-01

No results posted yet for this study

Summary

The study will specifically evaluate the potential of the C-Brace to improve the functional mobility and quality of life in individuals with lower extremity impairments due to neurologic or neuromuscular disease, orthopedic disease or trauma, as compared to the stance control orthosis.

Conditions

  • Spinal Cord Injuries
  • Poliomyelitis
  • Post-polio Syndrome
  • Arthritis
  • Lower Motor Neurone Lesion

Interventions

DEVICE

C-brace

The participant will receive 6 sessions of training over a one month period in using the C-brace in all levels of functional gait. The participant will then continue use of the C-brace for one month following training. The C-Brace from Otto Bock is an orthosis that controls throughout stance and swing phases of gait with a micro-processor (MP) controlled knee.

DEVICE

Stance control orthosis

The participant will receive 6 sessions of training over a one month period in using his current stance control knee-ankle-foot orthosis (SCO) in all levels of functional gait. The participant will then continue use of the SCO for one month following training. The SCO controls the knee by maintaining it straight and extended during the stance phase of gait.

Sponsors & Collaborators

  • Otto Bock Healthcare Products GmbH

    collaborator INDUSTRY

  • Shirley Ryan AbilityLab

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT02089880 on ClinicalTrials.gov