An interventional study of C-brace and Stance control orthosis in Spinal Cord Injuries, Poliomyelitis and Post-polio Syndrome, sponsored by Shirley Ryan AbilityLab. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-01.
Sponsored by Shirley Ryan AbilityLab · Not applicable, Interventional, and Supportive care
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.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 24 is close to the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Shirley Ryan AbilityLab is the lead sponsor of 180 studies on the registry; 44 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 4 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: C-brace · Device: Stance control orthosis
Device: C-brace · Device: Stance control orthosis
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
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.
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.
Time frame: Change from baseline in 6MWT using device 1 at 8 weeks and using device 2 at 16 weeks.
Muscle strength
Muscle strength with be assessed using a hand held dynamometer for muscle strength testing of the lower limb.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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.
Modified Falls Efficacy Scale
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."
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.
Orthotics and Prosthetics User Survey
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.
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.
World Health Organization Quality of Life, brief form (WHOQOL-BREF)
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.
Time frame: Change from baseline in WHOQOL-BREF after device 1 use at 8 weeks and after device 2 use at 16 weeks.
Global Positioning System (GPS)
GPS will be used to measure community mobility during the home use period, at baseline and after training with each device.
Time frame: Change from baseline measurement after device 1 training at 8 weeks and after device 2 training at 16 weeks.
Actigraph
The Actigraph is a small accelerometer worn on a belt which can identify performance of functional activities during use.
Time frame: Change from baseline measurement after device 1 training at 8 weeks and after device 2 training at 16 weeks.
Metria Sensor A wireless wearable sensor used in conjunction with the Actigraph to measure activity and monitor vitals and energy use during functional activities.
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.
Time frame: Change from baseline measurement after device 1 training at 8 weeks and after device 2 training at 16 weeks.
This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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