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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Rehabilitation Institute of Chicago
Sponsor:
Collaborator:
Otto Bock Healthcare Products GmbH
Information provided by (Responsible Party):
Arun Jayaraman, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier:
NCT02089880
First received: February 26, 2014
Last updated: March 15, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Spinal Cord Injuries
Poliomyelitis
Post-polio Syndrome
Arthritis
Lower Motor Neurone Lesion
Device: C-brace
Device: Stance control orthosis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Micro-processor Controlled Knee-Ankle-Foot Orthosis (C-Brace) Versus Stance-control Knee-Ankle-Foot Orthosis (SCO): Functional Outcomes in Individuals With Lower Extremity Impairment

Resource links provided by NLM:


Further study details as provided by Rehabilitation Institute of Chicago:

Primary Outcome Measures:
  • Six minute walk test (6MWT) [ Time Frame: Change from baseline in 6MWT using device 1 at 8 weeks and using device 2 at 16 weeks. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Muscle strength [ Time Frame: Change from baseline in muscle strength after device 1 use at 8 weeks and after device 2 use at 16 weeks. ] [ Designated as safety issue: No ]
    Muscle strength with be assessed using a hand held dynamometer for muscle strength testing of the lower limb.

  • Passive and active range of motion [ Time Frame: Change from baseline in range of motion after device 1 use at 8 weeks and after device 2 use at 16 weeks. ] [ Designated as safety issue: No ]
  • 10 meter walk test [ Time Frame: Change from baseline in gait speed using device 1 at 8 weeks and using device 2 at 16 weeks. ] [ Designated as safety issue: No ]
    This test will examine the patient's gait speed. Patients will be directed to walk at their preferred maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 sec). The test will be recorded 2 times, with adequate rest in between. The average of the 2 times should be recorded.

  • Hill Assessment Index [ Time Frame: Change from baseline in hill descent using device 1 at 8 weeks and using device 2 at 16 weeks. ] [ Designated as safety issue: Yes ]
    The Hill Assessment Index is a 12 point ordinal scale used to assess different gait patterns during ascent or descent of slopes. It was developed to detect differences in function with different knee units for transfemoral prosthetics.

  • Stair Assessment Index [ Time Frame: Change from baseline in stair descent using device 1 at 8 weeks and using device 2 at 16 weeks. ] [ Designated as safety issue: Yes ]
    The Stair Assessment Index is a 14 point ordinal scale originally used to assess functional abilities during ascent and descent of stairs.

  • Cross Walk Blinking Signal Test [ Time Frame: Change from baseline in the Cross Walk Blinking Signal Test using device 1 at 8 weeks and using device 2 at 16 weeks. ] [ Designated as safety issue: Yes ]
    The cross walk blinking signal test will measure how long it takes a participant to cross a designated street. The street that is designated for the street is 2 lanes and has ramps from the sidewalk to the street. The distance measured will be from the end of the ramp or edge of the curb on either side of the street.

  • GAITRite Data Capture [ Time Frame: Change from baseline in gait parameters using device 1 at 8 weeks and using device 2 at 16 weeks. ] [ Designated as safety issue: No ]
    The GAITRite system automates measuring temporal and spatial gait parameters via an electronic walkway connected to a computer. The GAITRite electronic walkway contains sensor pads encapsulated in a carpet to collect gait information. The system can be laid over any flat surface. The GAITRite electronic walkway for the study shall be a minimum of 14 feet long. The GAITRite data capture was chosen as measurement of the patient's overall gait quality. Patients will be asked to walk at a self-selected speed across the GAITRite electronic walkway.

  • Berg Balance Scale [ Time Frame: Change from baseline in Berg Balance Scale score using device 1 at 8 weeks and using device 2 at 16 weeks. ] [ Designated as safety issue: Yes ]
    The Berg Balance Scale is a 14-item scale designed to measure balance in adults in a clinical setting. When scoring, the lowest response category that applies should be recorded. In each item, points should be deducted if the time or distance requirements are not met, the subject's performance requires supervision, or the subject requires assistance from support or examiner.

  • Functional Gait Assessment [ Time Frame: Change from baseline in Functional Gait Assessment scores using device 1 at 8 weeks and using device 2 at 16 weeks. ] [ Designated as safety issue: Yes ]
    The Functional Gait Assessment is a 10 item test used to assess postural stability during walking tasks. It has a maximum score of 30 with each item being scored 0-3. It may be performed with or without an assistive device; however, individuals lose a point on all items requiring a device.

  • 5 times sit to stand test [ Time Frame: Change from baseline in 5 times sit to stand test using device 1 at 8 weeks and using device 2 at 16 weeks. ] [ Designated as safety issue: No ]
    The 5 Time Sit to Stand Test is a measure of functional lower limb strength during transitional movement. The individual sits in a standard height chair (43-45 cm) and is instructed to stand up and sit down 5 times as quickly as possible.


Other Outcome Measures:
  • Modified Falls Efficacy Scale [ Time Frame: Change from baseline in Modified Falls Efficacy Scale after device 1 use at 8 weeks and after device 2 use at 16 weeks. ] [ Designated as safety issue: Yes ]
    The Modified Falls Efficacy Scale is self-report questionnaire consisting of 14 items which is designed to measure fear of falling in the elderly. It assesses an individual's perception of balance during activities of daily living by asking "how confident are you that you can do the following activities without falling."

  • Orthotics and Prosthetics User Survey [ Time Frame: Change from baseline in Orthotics and Prosthetics User Survey after device 1 use at 8 weeks and after device 2 use at 16 weeks. ] [ Designated as safety issue: No ]
    The Orthotic and Prosthetics User Survey is a self-report questionnaire which is designed to evaluate the outcome of orthotic and prosthetic services. We will administer three of the five domains: lower limb functional measure, health-related quality of life and satisfaction with device.

  • World Health Organization Quality of Life, brief form (WHOQOL-BREF) [ Time Frame: Change from baseline in WHOQOL-BREF after device 1 use at 8 weeks and after device 2 use at 16 weeks. ] [ Designated as safety issue: No ]
    The WHOQOL-BREF is a self-report questionnaire that measures an individual's perceived quality of life. It contains four domains which cover physical health, psychological health, social relationships, and environment. Scores range from 0-100 with 100 indicating a higher quality of life.

  • Global Positioning System (GPS) [ Time Frame: Change from baseline measurement after device 1 training at 8 weeks and after device 2 training at 16 weeks. ] [ Designated as safety issue: No ]
    GPS will be used to measure community mobility during the home use period, at baseline and after training with each device.

  • Actigraph [ Time Frame: Change from baseline measurement after device 1 training at 8 weeks and after device 2 training at 16 weeks. ] [ Designated as safety issue: No ]
    The Actigraph is a small accelerometer worn on a belt which can identify performance of functional activities during use.

  • Metria Sensor A wireless wearable sensor used in conjunction with the Actigraph to measure activity and monitor vitals and energy use during functional activities. [ Time Frame: Change from baseline measurement after device 1 training at 8 weeks and after device 2 training at 16 weeks. ] [ Designated as safety issue: No ]
    The Metria Sensor is a wireless wearable sensor used in conjunction with the Actigraph to measure activity and monitor vitals and energy use during functional activities.


Estimated Enrollment: 24
Study Start Date: February 2014
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: C-brace then stance control orthosis 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.
Other Name: C-Brace by Ottobock
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.
Experimental: Stance control orthosis then C-brace 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.
Other Name: C-Brace by Ottobock
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Lower extremity functional impairment due to neurologic or neuromuscular disease, orthopedic disease or trauma.
  • Prior active and compliant use of unilateral SCO.
  • Age 18 - 80 years.
  • Demonstrate a reciprocal gait pattern using current SCO.
  • 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.
  • Participating in physical therapy currently or within 1 month of starting protocol, specific to orthotic use and gait training.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02089880

Contacts
Contact: Arun Jayaraman, PT, PhD 312-238-6875 ajayaraman@ricres.org
Contact: Lori McGee Koch 312-238-2091 lmkoch@ricres.org

Locations
United States, Illinois
Rehabilitation Institute of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Lori McGee Koch    312-238-2091    lmkoch@ricres.org   
Contact: McGee Koch         
Principal Investigator: Arun Jayaraman, PT, PhD         
Sponsors and Collaborators
Rehabilitation Institute of Chicago
Otto Bock Healthcare Products GmbH
  More Information

No publications provided

Responsible Party: Arun Jayaraman, Research Scientist, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier: NCT02089880     History of Changes
Other Study ID Numbers: 85951
Study First Received: February 26, 2014
Last Updated: March 15, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Poliomyelitis
Postpoliomyelitis Syndrome
Spinal Cord Injuries
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Enterovirus Infections
Muscular Diseases
Muscular Disorders, Atrophic
Musculoskeletal Diseases
Myelitis
Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Picornaviridae Infections
RNA Virus Infections
Spinal Cord Diseases
Trauma, Nervous System
Virus Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014