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Robotic suits tested to boost life quality after spinal injury

NCT ID NCT05811884

Symptom relief Sponsor: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether using a powered exoskeleton to walk can improve quality of life for people with spinal cord injury. Eighteen participants will either use the device at home or in a clinic over 24 months. Researchers will measure changes in well-being and compare costs of both approaches.

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 18 people

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

Expected to start

Jan 2030

An estimate. Start dates often move.

Expected to finish

Feb 2033

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 65 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.

Inclusion Criteria: * Assisted by Inail; * Age between 18 and 65 years; * Body weight lower than 113 Kg; * Level of spinal lesion T4 and higher; * Integrity of upper limbs (strength and range of motion assessed by a clinical operator); * Abbreviated Injury Scale (AIS) score A or B; * Number of months after lesion higher than 6; * Anthropometry in conformity with the declarations of exoskeleton's manufacturers. Exclusion Criteria: * Use of the powered exoskeleton in the last 6 months (in this case a wash-out phase is required); * Use of colostomy bag; * The subject is pregnant/ nursing; * Presence of cognitive impairments; * Presence of severe neurologic lesions in addition to SCI (sclerosis, cerebral palsy or trauma,…); * Severe comorbidities; * Uncontrolled hypertension or orthostatic hypotension; * Uncontrolled autonomic dysreflexia; * Problems at the skeletal system: T-score of femoral neck lower than -3 (DEXA examination is required), bone mineral density of proximal tibia or distal femur lower than 0.6 g/cm2, presence of non-recovered fractures, ectopic ossification, unstable spine; * Kinesiologic impairments of the lower limbs: Ashworth spasticity of hamstrings, quadriceps, gastrocnemius muscles (right/ left) lower than 4, uncontrolled clonic spasm, pathologic contractures: non conformity of the range of motion of ankle/ knee/ hip with the requisites for use of powered exoskeletons for ambulation, presence of pressure lesions, dysmetria: femurs higher than 1.5 cm/ tibias higher than 2 cm; * Kinesiologic impairments of the upper limbs: limitations at the joints, weakness of shoulder/ elbow/ hand (manual evaluation by a clinician), no autonomy in transfers; * Weak control of the trunk; * Inability to stand for at least 30 minutes; * Presence of joint prostheses in upper and lower limbs; * Use of drugs that may affect cognition and coordination while using the exoskeleton.

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Conditions

The condition(s) this trial relates to.

spinal cord injury

As listed by the trial registrant

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

Spinal cord injuries

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Centro Protesi Inail

    Budrio, Bologna, 40054, Italy

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