Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
30 participants
INTERVENTIONAL
2019-04-16
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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C-Brace II Group
Subjects will be assigned a C-Brace II orthotic for use.
C-Brace II
Participant will complete 3-6 orthoses sessions to complete clinical evaluations and fittings conducted by certified orthotists.
Participant will receive 10-20, one hour training sessions over 1-2 months in the lab. These sessions include tuning the device and system tweaks in accordance to needs/preferences of participant, vitals signs, skin checks, pain, and exertion levels. Sessions involve training with the device, which includes putting on / taking off the device, transfer training, gait training, and balance and fall prevention.
Up to 20 sessions will be conducted until minimum safety guidelines are reached during a minimum of at least 3 training sessions in a row.
Participant will take the assigned device home to use for a 3-month period. Participant will be given an activity monitor to wear at all times except showering and instructed how to charge the device and use it. Participant will return for testing at 3, 6 and 12 months after receiving the brace for testing.
Traditional Group
Subjects will continue with their own KAFO (non C-Brace II) use.
Traditional Care KAFO intervention
Participant will continue with use of their own KAFO. Participant will receive 10-20, one hour training sessions over 1-2 months in the lab, if Patient is not already receiving care in a therapy setting. These sessions include tuning the device and system tweaks in accordance to needs/preferences of participant, vitals signs, skin checks, pain, and exertion levels. Sessions involve training with the device, which includes putting on / taking off the device, transfer training, gait training, and balance and fall prevention. Up to 20 sessions will be conducted until minimum safety guidelines are reached during a minimum of at least 3 training sessions in a row. Participant will continue with the assigned device home to use for a 3-month period. Participant will be given an activity monitor to wear at all times except showering and instructed how to charge the device and use it. Participant will return for testing at 3, 6 and 12 months after receiving the brace for testing.
Interventions
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C-Brace II
Participant will complete 3-6 orthoses sessions to complete clinical evaluations and fittings conducted by certified orthotists.
Participant will receive 10-20, one hour training sessions over 1-2 months in the lab. These sessions include tuning the device and system tweaks in accordance to needs/preferences of participant, vitals signs, skin checks, pain, and exertion levels. Sessions involve training with the device, which includes putting on / taking off the device, transfer training, gait training, and balance and fall prevention.
Up to 20 sessions will be conducted until minimum safety guidelines are reached during a minimum of at least 3 training sessions in a row.
Participant will take the assigned device home to use for a 3-month period. Participant will be given an activity monitor to wear at all times except showering and instructed how to charge the device and use it. Participant will return for testing at 3, 6 and 12 months after receiving the brace for testing.
Traditional Care KAFO intervention
Participant will continue with use of their own KAFO. Participant will receive 10-20, one hour training sessions over 1-2 months in the lab, if Patient is not already receiving care in a therapy setting. These sessions include tuning the device and system tweaks in accordance to needs/preferences of participant, vitals signs, skin checks, pain, and exertion levels. Sessions involve training with the device, which includes putting on / taking off the device, transfer training, gait training, and balance and fall prevention. Up to 20 sessions will be conducted until minimum safety guidelines are reached during a minimum of at least 3 training sessions in a row. Participant will continue with the assigned device home to use for a 3-month period. Participant will be given an activity monitor to wear at all times except showering and instructed how to charge the device and use it. Participant will return for testing at 3, 6 and 12 months after receiving the brace for testing.
Eligibility Criteria
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Inclusion Criteria
* 18-80 years
* Must be able to demonstrate the ability to charge assigned sensors during 3-month home trial period on and off and sufficient memory ability to wear the devices each day during use of the orthoses.
* Requires orthotic bracing for lower extremity instability, including the knee joint, unilaterally or bilaterally
Exclusion Criteria
* Cognitive impairments that limit study participation
* Body weight over 275 lbs
* Flexion contracture in the knee and/or hip joint in excess of 10 degrees
* Non-correctable knee varus/valgus in excess of 10 degrees
* Moderate to severe spasticity
* Leg length discrepancy in excess of 6" (15.24 cm)
* Inability to stabilize the trunk with or without assistive devices (crutches, cane, etc.)
* Inability to successfully use C-Brace trial tool in advancement of leg/s.
18 Years
80 Years
ALL
No
Sponsors
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Otto Bock Healthcare Products GmbH
INDUSTRY
Shirley Ryan AbilityLab
OTHER
Responsible Party
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Arun Jayaraman, PT, PhD
Research Scientist
Locations
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Shirley Ryan AbilityLab
Chicago, Illinois, United States
Countries
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Other Identifiers
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STU00208781
Identifier Type: -
Identifier Source: org_study_id