Clinical trial Recruiting at 1 site Interventional Ages 18 to 65

Evaluating brain and technology interaction after below-knee amputation

Official title: Human-Prosthetic Interaction: Brain & Technology After Lower-Limb Loss

Run by Vrije Universiteit Brussel · NCT05818410 · Data updated 2026-11-12

This study is testing how a new passive prosthetic ankle helps people who have had a leg amputated improve their walking and brain function compared to those without amputations.

Quick facts

Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment60 (estimated)
SponsorVrije Universiteit Brussel
Academic / other
Locations1 site (Brussels)
StatusRecruiting
StartedJanuary 16, 2024
Main results expectedDecember 2028
Study endsDecember 2028
Registry record updatedFebruary 24, 2025
Trial IDNCT05818410 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals with unilateral transtibial (below knee) amputation who are healthy and classified as K3-4 on the Medicare Functional Classification.

Probably not a fit

Patients with neurological diseases, upper limb or bilateral amputations, osseointegration, metal implants, or diabetes may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of a passive prosthetic ankle, Lunaris®, on brain neuroplasticity and functional performance in individuals with unilateral lower limb amputation. Participants will undergo MRI scans and functional performance tests at the University Hospital Brussels, comparing their outcomes with able-bodied individuals. The trial includes a rehabilitation phase where participants will learn to walk with either the Lunaris® or a conventional SACH foot® prosthesis, followed by an intervention period where they will use the assigned prosthetic device in daily activities.

Why it matters

Potential benefit: If successful, this study could enhance rehabilitation outcomes and quality of life for patients with lower limb amputations.

How similar studies have gone: While the approach of evaluating neuroplasticity in relation to prosthetic devices is innovative, similar studies have shown promising results in enhancing rehabilitation outcomes.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Unilateral transtibial (below knee) amputation
* Healthy subject
* Medicare Functional Classification Level: K3-4

Exclusion Criteria:

* Any neurological disease
* Upper limb or bilateral amputation
* Osso-integration
* Metal implants
* Diabetes

Where it's running

  • Vrije Universiteit Brussel
    Brussels, Belgium
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.