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

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Device: C-brace
* Device: Stance control orthosis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C-brace then stance control orthosis<br> | Device: C-brace<br>* 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.<br>* Other names: C-Brace by Ottobock;Device: Stance control orthosis<br>* 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.<br>|
| Experimental: Stance control orthosis then C-brace<br> | Device: C-brace<br>* 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.<br>* Other names: C-Brace by Ottobock;Device: Stance control orthosis<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength | Muscle strength with be assessed using a hand held dynamometer for muscle strength testing of the lower limb. | 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 | 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. | Change from baseline in gait speed using device 1 at 8 weeks and using device 2 at 16 weeks. | 
| Hill Assessment Index | 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. | Change from baseline in hill descent using device 1 at 8 weeks and using device 2 at 16 weeks. | 
| Stair Assessment Index | The Stair Assessment Index is a 14 point ordinal scale originally used to assess functional abilities during ascent and descent of stairs. | Change from baseline in stair descent using device 1 at 8 weeks and using device 2 at 16 weeks. | 
| Cross Walk Blinking Signal Test | 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. | Change from baseline in the Cross Walk Blinking Signal Test using device 1 at 8 weeks and using device 2 at 16 weeks. | 
| GAITRite Data Capture | 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. | Change from baseline in gait parameters using device 1 at 8 weeks and using device 2 at 16 weeks. | 
| Berg Balance Scale | 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. | Change from baseline in Berg Balance Scale score using device 1 at 8 weeks and using device 2 at 16 weeks. | 
| Functional Gait Assessment | 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. | Change from baseline in Functional Gait Assessment scores using device 1 at 8 weeks and using device 2 at 16 weeks. | 
| 5 times sit to stand test | 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. | Change from baseline in 5 times sit to stand test using device 1 at 8 weeks and using device 2 at 16 weeks. |