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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of the NEUROSWING Orthosis on Walking Speed in a Population With Dorsal and/or Plantar Flexor Deficits, With a View to a Reimbursement Application

NCT07108088

Stroke Multiple Sclerosis Cerebral Palsy +1 more

NOT_YET_RECRUITING NA

C-BRACE Versus SCO in Community Ambulators

NCT05332509

Lower Limb Pareses

COMPLETED NA

Clinical Trial Comparing C-Brace to Knee Ankle Foot Orthosis (KAFO)/Stance Control Orthosis (SCO)

NCT03906656

Pareses, Lower Extremity

COMPLETED NA

Evaluation of the Effect of an Ankle Foot Orthoses for Ambulatory Function

NCT01336517

Hemiplegia, Spastic

COMPLETED

Microprocessor Knees in Early Rehabilitation

NCT03433300

Amputation

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

C-brace then stance control orthosis

Group Type EXPERIMENTAL

C-brace

Intervention Type DEVICE

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.

Stance control orthosis

Intervention Type DEVICE

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.

Stance control orthosis then C-brace

Group Type EXPERIMENTAL

C-brace

Intervention Type DEVICE

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.

Stance control orthosis

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

C-Brace by Ottobock

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Lower extremity functional impairment due to neurologic or neuromuscular disease, orthopedic disease or trauma.
* Prior active and compliant use of unilateral Knee-ankle-foot orthosis (KAFO) or Stance control orthosis (SCO).
* Age 18 - 80 years.
* Demonstrate a reciprocal gait pattern using the SCO and C-Brace trial tools.
* Cognitive ability to understand and the willingness to sign a written informed consent.
* Subjects must be able to demonstrate the ability to turn the global positioning sensor (GPS) and Actigraph units on and off and sufficient memory ability to wear the devices each day during use of the orthoses.

Exclusion Criteria

* Passive ankle range of motion (PROM) of the lower extremity requiring the knee-ankle-foot orthosis (KAFO) of less than 2 degrees.
* Body weight \>275 pounds.
* Unstable neurological or cardiovascular/pulmonary disease, cancer.
* Knee flexion contracture resulting in the inability to actively use C-Brace or SCO.
* Participating in physical therapy currently or within 1 month of starting protocol, specific to orthotic use and gait training.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No