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New prosthetic grows with kids: no more frequent replacements?

NCT ID NCT05230004

Symptom relief Sponsor: University of Pennsylvania Source: ClinicalTrials.gov ↗

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This study is testing a new type of prosthetic leg for children aged 3 to 18 that can be easily adjusted as they grow. The device is designed to be fitted in a single session and adjusted by the wearer. Researchers will measure comfort, socket pressure, walking speed, and quality of life during lab tests and a two-month home trial.

What this could mean

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

Active substance
iFIT adjustable modular prosthesis
What this could lead to
If successful, this could provide a more comfortable, easy-to-adjust prosthetic for growing children, reducing the need for frequent replacements.
What could go wrong
This is a small early-stage trial with only 28 participants, so results may not apply to all children. The device may not work as well in real-world use or for all types of limb loss.

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

35 people

The number who actually took part.

Started

Aug 2022

Finished

Jun 2026

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

3 to 18 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: * Four months post-amputation * Subjects who have lost a limb due to any cause: trauma, congenital limb loss, dysvascular causes (peripheral vascular disease and diabetes), or malignancy will all be eligible for inclusion. * Intact, protective sensation in their residual limbs. Exclusion Criteria: * open skin lesions * excessive pain in the residual limb (phantom pain, residual limb pain, or neuroma) * neurological disorders (e.g., stroke, severe polyneuropathy) causing weakness in the contralateral leg or marked gait impairment * inability to follow instructions for trial

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Conditions

The condition(s) this trial relates to.

childhood acute lymphoblastic leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

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

Limb deficiencies Pediatric ALL

Contacts and locations

Locations

  • Penn Medicine Rittenhouse

    Philadelphia, Pennsylvania, 19146, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.