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Smart brace aims to help spinal cord injury patients walk farther

NCT ID NCT03930056

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2019

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • Shirley Ryan AbilityLab

    Chicago, Illinois, 60611, United States

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