Smart brace aims to help spinal cord injury patients walk farther
NCT ID NCT03930056
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares a high-tech, computer-controlled knee-ankle-foot brace (C-Brace) to traditional braces in 30 people with spinal cord injury. Participants will train with the device for up to 20 sessions and then use it at home for 3 months. The main goal is to see if the smart brace helps them walk longer distances in 6 minutes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- C-Brace II (micro-processor controlled knee-ankle-foot orthosis)
- What this could lead to
- If it works, this could show that a smart brace helps people with spinal cord injury walk farther and more safely than traditional braces.
- What could go wrong
- This is a small, early-stage study with only 30 participants, so results may not apply to everyone. The device may not improve walking enough to justify its cost or complexity.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2019
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
All participants: Inclusion Criteria: * Be within 3-24 months post spinal cord injury diagnosis * 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. Exclusion Criteria: * Unstable neurological, cardiovascular, or cancer diagnoses. * Cognitive impairments that limit study participation In addition to the above inclusion criteria, the following criteria must be met to be designated into the study interventional tract (C-Brace II): Inclusion criteria: * Requires orthotic bracing for lower extremity instability, including the knee joint, unilaterally or bilaterally Exclusion criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Shirley Ryan AbilityLab
Chicago, Illinois, 60611, United States
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Other studies related to the condition(s) this trial covers.
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