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

NCT02089880 | Active Not Recruiting

• 1 other identifier: 85951
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Six minute walk test (6MWT)

  The test measures the distance that the patient can walk on a flat, hard surface, indoors, in a period of 6 minutes. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. This test will be administered while wearing a mask to measure oxygen consumption.

  Change from baseline in 6MWT using device 1 at 8 weeks and using device 2 at 16 weeks.

Secondary Outcomes (10)

• Muscle strength

  Change from baseline in muscle strength after device 1 use at 8 weeks and after device 2 use at 16 weeks.

• Passive and active range of motion

  Change from baseline in range of motion after device 1 use at 8 weeks and after device 2 use at 16 weeks.

• 10 meter walk test

  Change from baseline in gait speed using device 1 at 8 weeks and using device 2 at 16 weeks.

• Hill Assessment Index

  Change from baseline in hill descent using device 1 at 8 weeks and using device 2 at 16 weeks.

• Stair Assessment Index

  Change from baseline in stair descent using device 1 at 8 weeks and using device 2 at 16 weeks.

Other Outcomes (6)

• Modified Falls Efficacy Scale

  Change from baseline in Modified Falls Efficacy Scale after device 1 use at 8 weeks and after device 2 use at 16 weeks.

• Orthotics and Prosthetics User Survey

  Change from baseline in Orthotics and Prosthetics User Survey after device 1 use at 8 weeks and after device 2 use at 16 weeks.

• World Health Organization Quality of Life, brief form (WHOQOL-BREF)

  Change from baseline in WHOQOL-BREF after device 1 use at 8 weeks and after device 2 use at 16 weeks.

Study Arms (2)

C-brace then stance control orthosis

EXPERIMENTAL

Device: C-brace; Device: Stance control orthosis

Stance control orthosis then C-brace

EXPERIMENTAL

Device: C-brace; Device: Stance control orthosis

Interventions

C-brace 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.

Also known as: C-Brace by Ottobock

C-brace then stance control orthosis; Stance control orthosis then C-brace

Stance control orthosis 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.

C-brace then stance control orthosis; Stance control orthosis then C-brace

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• Otto Bock Healthcare Products GmbH: collaborator

Study Sites (1)

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Deems-Dluhy S, Hoppe-Ludwig S, Mummidisetty CK, Semik P, Heinemann AW, Jayaraman A. Microprocessor Controlled Knee Ankle Foot Orthosis (KAFO) vs Stance Control vs Locked KAFO: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 Feb;102(2):233-244. doi: 10.1016/j.apmr.2020.08.013. Epub 2020 Sep 22.

  PMID: 32976844 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Poliomyelitis; Postpoliomyelitis Syndrome; Arthritis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neurodegenerative Diseases; Joint Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: March 18, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

US (1)