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Robotic legs may help rebuild bone in people with spinal cord injury

NCT ID NCT02533713

Disease control Sponsor: Craig Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests whether regular walking with a robotic exoskeleton can improve bone health and quality of life in people with spinal cord injury. Participants will train three times a week for 26 weeks, aiming for an hour of continuous walking each session. Researchers will measure changes in bone stiffness and volume at the knee, as well as mood, to see if the device offers benefits beyond standard care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Exoskeleton-assisted gait training, a wearable robotic device that enables walking, performed three times a week for 26 weeks under the guidance of a physical therapist.
What this could lead to
If it works, this could point toward a way to slow or reverse bone loss and improve mood and quality of life for people with spinal cord injury who cannot walk.
What could go wrong
This is a small, early-stage trial, and results may not apply to everyone. The training is demanding, and there is a risk of falls or skin issues from the device.

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

61 people

The number who actually took part.

Started

Jun 2017

Finished

Dec 2021

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 years and older

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.

Inclusion Criteria: * 3 years or more after injury * Motor complete SCI (AIS A and B) or AIS C or D who are non-ambulatory * SCI C07-T12 * 155-191 centimeters tall * Weigh less than 113 kilograms * Have a Modified Ashworth Scale (MAS) score of less than 3 in both lower extremities * Have sufficient upper body strength to complete sit to sit transfers * Women of childbearing potential must agree to use contraceptive measures during participation in the study. They also will be required to have a negative pregnancy test (urine or serum) before receiving an imaging studies. Exclusion Criteria: * Current enrollment in another clinical trial * Pregnancy * Orthostatic hypotension with symptomatic fall in blood pressure \>30 mmHg when upright * An active grade 2 or greater pressure ulcer that can be worsened by walking in the device * Lower extremity contractures that interfere with the ability to wear the device * An unhealed limb or pelvic bone fracture history of other neurological disease (e.g. stroke, peripheral neuropathy, myopathy) * Active treatment for epilepsy or thyroid disorders * Current use of medications potentially affecting bone health (bisphosphonates, androgenic steroids, estrogenic steroids, lithium, glucocorticoid use for more than 3 months) * Women with osteoporosis detected at baseline DXA testing due to the high rate of study-related fractures observed in this group * Subjects with MRI-incompatible implants, pumps, or neurostimulators may be enrolled but will not undergo MRI studies

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Conditions

The condition(s) this trial relates to.

osteoporosis spinal cord injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteoporosis

Contacts and locations

Locations

  • Craig Hospital

    Englewood, Colorado, 80113, United States

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