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 type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Vrije Universiteit Brussel Academic / other |
| Locations | 1 site (Brussels) |
| Status | Recruiting |
| Started | January 16, 2024 |
| Main results expected | December 2028 |
| Study ends | December 2028 |
| Registry record updated | February 24, 2025 |
| Trial ID | NCT05818410 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
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Vrije Universiteit Brussel
Brussels, Belgium Recruiting
Study contacts
- Principal investigator: Kevin De Pauw — Vrije Universiteit Brussel
- Study coordinator: Kevin De Pauw
- Email: Kevin.De.Pauw@vub.be
- Phone: +32 (0)2 629 27 53
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Try the Caesar take-home foot for everyday use and running
This trial tests whether people with below‑knee amputations who are interested in running can use the bimodal Caesar foot at home for two months to see if it improves mobility and daily activity.
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Improving balance and control for below-knee amputees using advanced prosthetics
This study tests if using advanced powered prosthetic ankles controlled by muscle signals can help people with below-knee amputations improve their balance and movement compared to regular prosthetics.
-
Improving walking skills for lower limb prosthesis users on uneven terrain
This study tests a walking program for people using lower limb prostheses to see if training on uneven surfaces helps them walk better and feel more confident.
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A new system to assess prosthetic socket fit for lower limb amputees
This study is testing a new pressure sensing pad to see if it can help lower limb amputees get a better and more comfortable fit for their prosthetic sockets.
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Automatically adjusting prosthetic socket for below-knee amputees
This study is testing a new type of prosthetic socket that automatically adjusts to fit better for people with below-knee amputations, making it more comfortable and reducing the risk of pain or skin problems.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.