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Hands-free robot suit lets people with spinal cord injury walk and do daily tasks

NCT ID NCT06814015

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a hands-free, self-balancing exoskeleton designed to help people with spinal cord injury walk and perform everyday activities. The trial will enroll 24 participants who will train with the device over several sessions. Researchers will measure how quickly they can walk and how well they complete daily tasks like moving around a kitchen or living room.

What this could mean

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

Active substance
Hands-free, self-balancing personal exoskeleton (device)
What this could lead to
If successful, this exoskeleton could offer a practical way for people with spinal cord injury to walk and perform daily activities without using their hands.
What could go wrong
This is an early-stage study with only 24 participants, so results may not apply to everyone. The device requires training and may not work for all injury levels.

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 24 people

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

Started

Mar 2025

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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

Accepted

You do not need to have the condition being studied to take part.

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.

SCI user inclusion Criteria: * Any gender, age 18 years or older; * Motor complete or incomplete SCI with lesions at or above T6; * ≥ 6 months post SCI; * Able and willing to attend 9 to 10 visits1 to the center, including sessions of training and assessments of one-to-three hours duration; * Able to read, understand, and provide informed consent; * Living in the US and speaks English. SCI user exclusion Criteria: * Diagnosis of neurological injury other than SCI; * Progressive condition that would be expected to result in changing neurological status; * Severe concurrent medical disease, illness or condition judged to be contraindicated by the site physician; * Unhealed or unstable traumatic or high impact lower extremity fracture of any duration that is, in the clinical judgement of the study physician, exclusionary for standing and walking; * Knee (proximal tibia and/or distal femur) BMD \<0.60 gm/cm2; * Total hip BMD T-scores \< -3.5; * Fragility, minimal trauma, or low impact fracture of the lower extremity since SCI; * Untreatable severe spasticity judged to be contraindicated by the site physician; * Untreated/uncontrolled hypertension, as judged to be contraindicated by the site physician; * Unresolved orthostatic hypotension (change from baseline seated BP to a fall in 20mmHg SBP and/or fall in 10mmHG DBP and symptoms when standing), or as judged to be contraindicated by the site physician; * Open or unhealed skin pressure sores, abrasions, or bruises at any of the contact points of the exoskeleton; * Morphological contraindications to the use of the device; * Uncorrectable leg length discrepancy over 2 cm (about 0.79 in) when using additional correction tools; * Unable to effectively operate the device with a hand-control interface, due to functional and/or cognitive impairment, evaluated based on the ability to manipulate the joystick in all direction, press and identify buttons on the hand control interface. * Improper fitting in the device; * Psychopathology documentation in the medical record that may conflict with study objectives; * Pregnancy or women who plan to become pregnant during the study period; * Concurrent participation in another interventional trial; * History of uncontrolled autonomic dysreflexia; * Presence colostomy and/or urostomy; * Ventilator use at the time of the exoskeleton use; * Insufficient strength and performance capability (the ability to transfer into/out of the device or perform other training tasks with assistance). Companion inclusion Criteria: * Any gender, age 18 years or older; * Willingness to attend 9 to 10 visits to the center, including sessions of training and assessments of one-to-three hours duration with the SCI user; * Able to read, understand and provide informed consent; * Living in the US and speaks English. Companion exclusion Criteria: * Inability to communicate with an assistant due to cognitive and language disorders; * Any disease, concomitant injury, or condition that interferes with the performance or interpretation of the protocol- specified assessments; * Insufficient strength and performance capability, evidenced by the ability to hold and retain the device in case of unbalance/fall; * Insufficient availability to complete the study; * Concurrent participation in another interventional trial.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Kessler Foundation

    RECRUITING

    West Orange, New Jersey, 07052, United States

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