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New rehab approach aims to help amputees walk and feel better

NCT ID NCT06471855

Knowledge-focused Sponsor: Istituti Clinici Scientifici Maugeri SpA Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 70 people who have lost a lower limb due to diabetes or vascular disease. It looks at how they adjust physically and emotionally over time. Some participants will receive a standard rehab program, while others will also use technology-based exercises. The goal is to see if the new approach improves mobility, independence, and quality of life.

What this could mean

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

Active substance
Multidisciplinary conventional and technology-based rehabilitation
What this could lead to
If successful, this could point toward better rehabilitation programs that improve mobility, independence, and emotional well-being for people with lower limb amputations.
What could go wrong
This is an early-stage study with only 70 participants, so results may not apply to everyone. The technology-based rehab may not be more effective than standard care.

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 70 people

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

Started

Jun 2023

Expected to finish

Jun 2027

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

Up 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.

Inclusion Criteria: * Risk of amputation or Lower limb amputation or prothesis use for vascular disease and diabetes type 2 Exclusion Criteria: * more than 80 years older * severe clinical condition (ie, chronic heart failure \[New York Heart Association Classification-IV - NYHA-IV\], ischemic heart disease \[Canadian Cardiovascular Society Classification-IV - CCS-IV\], neoplastic disease, acute respiratory disease); * non-Italian education * severe visual-perceptive deficits * severe cognitive impairment (MMSE ≤ 26 Foderaro et al, 2022); * severe mental health condition or psychiatric disorder compromising participation in the study; * absence or withdrawal of the informed consent to participate.

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As listed by the trial registrant

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

Lower limb amputation Prosthesis user

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

  • Istituti Clinici Scientifici Maugeri, IRCCS

    RECRUITING

    Pavia, PV, 27100, Italy

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