Clinical trial NCT02089880: Comparing Functional Outcomes in Individuals Using Micro-processor Controlled Orthosis Versus Stance Control Orthosis
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Poliomyelitis
Post-polio Syndrome
Arthritis
Lower Motor Neurone Lesion
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: Otto Bock Healthcare Products GmbH
First posted: 2014-03-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Six minute walk test (6MWT)
timeFrame: Change from baseline in 6MWT using device 1 at 8 weeks and using device 2 at 16 weeks.
Secondary outcomes:
measure: Muscle strength
timeFrame: Change from baseline in muscle strength after device 1 use at 8 weeks and after device 2 use at 16 weeks.
measure: Passive and active range of motion
timeFrame: Change from baseline in range of motion after device 1 use at 8 weeks and after device 2 use at 16 weeks.
measure: 10 meter walk test
timeFrame: Change from baseline in gait speed using device 1 at 8 weeks and using device 2 at 16 weeks.
measure: Hill Assessment Index
timeFrame: Change from baseline in hill descent using device 1 at 8 weeks and using device 2 at 16 weeks.
measure: Stair Assessment Index
timeFrame: Change from baseline in stair descent using device 1 at 8 weeks and using device 2 at 16 weeks.
measure: Cross Walk Blinking Signal Test
timeFrame: Change from baseline in the Cross Walk Blinking Signal Test using device 1 at 8 weeks and using device 2 at 16 weeks.
measure: GAITRite Data Capture
timeFrame: Change from baseline in gait parameters using device 1 at 8 weeks and using device 2 at 16 weeks.
measure: Berg Balance Scale
timeFrame: Change from baseline in Berg Balance Scale score using device 1 at 8 weeks and using device 2 at 16 weeks.
measure: Functional Gait Assessment
timeFrame: Change from baseline in Functional Gait Assessment scores using device 1 at 8 weeks and using device 2 at 16 weeks.
measure: 5 times sit to stand test
timeFrame: Change from baseline in 5 times sit to stand test using device 1 at 8 weeks and using device 2 at 16 weeks.
Other outcomes:
measure: Modified Falls Efficacy Scale
timeFrame: Change from baseline in Modified Falls Efficacy Scale after device 1 use at 8 weeks and after device 2 use at 16 weeks.
measure: Orthotics and Prosthetics User Survey
timeFrame: Change from baseline in Orthotics and Prosthetics User Survey after device 1 use at 8 weeks and after device 2 use at 16 weeks.
measure: World Health Organization Quality of Life, brief form (WHOQOL-BREF)
timeFrame: Change from baseline in WHOQOL-BREF after device 1 use at 8 weeks and after device 2 use at 16 weeks.
measure: Global Positioning System (GPS)
timeFrame: Change from baseline measurement after device 1 training at 8 weeks and after device 2 training at 16 weeks.
measure: Actigraph
timeFrame: Change from baseline measurement after device 1 training at 8 weeks and after device 2 training at 16 weeks.
measure: Metria Sensor A wireless wearable sensor used in conjunction with the Actigraph to measure activity and monitor vitals and energy use during functional activities.
timeFrame: Change from baseline measurement after device 1 training at 8 weeks and after device 2 training at 16 weeks.
Locations:
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
Study officials:
References:
citation: 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.