Evaluating brain and technology interaction after below-knee amputation
Human-Prosthetic Interaction: Brain & Technology After Lower-Limb Loss
NA · Vrije Universiteit Brussel · NCT05818410
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Vrije Universiteit Brussel (other) |
| Locations | 1 site (Brussels) |
| Trial ID | NCT05818410 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with neurological diseases, upper limb or bilateral amputations, osseointegration, metal implants, or diabetes may not benefit from this study.
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 performed: While the approach of evaluating neuroplasticity in relation to prosthetic devices is innovative, similar studies have shown promising results in enhancing rehabilitation outcomes.
Eligibility criteria
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 this trial is running
Brussels
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lower Limb Amputation Below Knee