Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID05818410

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

Led by Vrije Universiteit Brussel · Updated on 2025-02-24

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying brain neuroplasticity and functional performance in people who have lost one lower limb below the knee. The study compares the effects of using a passive prosthetic ankle (Lunaris) with a conventional prosthetic foot (SACH foot) and also includes a control group of able-bodied individuals for comparison. The goal is to understand how different prosthetic devices influence brain changes and movement patterns after amputation. Participants with lower limb amputation will begin the study at the start of their rehabilitation. They will receive either the Lunaris prosthetic foot or the SACH foot and learn to walk with it over 12 weeks. During this time, those with the SACH foot may try other new prosthetic devices as part of usual care. Able-bodied participants will undergo MRI scans and functional performance tests on two separate days. After the 12-week learning phase, participants with amputation will continue to use their assigned prosthesis for an additional 12 weeks while performing daily activities, with final assessments at week 24. All participants will undergo MRI brain scans and perform functional tests at baseline and after the intervention period to measure changes in brain neuroplasticity and physical performance. Participants with amputation will also complete questionnaires about their quality of life and satisfaction with their prosthetic devices. The study includes four test days for participants with amputation and two days for able-bodied individuals. This approach helps researchers monitor brain and movement changes over 24 weeks and evaluate how different prosthetic devices affect outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Unilateral transtibial (below knee) amputation
  • Healthy subject
  • Medicare Functional Classification Level: K3-4
  • Age between 18 and 65 years
  • All genders
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Diagnostic Evaluation

Duration - Week 0

Participants undergo baseline MRI scans and functional performance tests to assess initial brain neuroplasticity and movement patterns.

1 baseline visit (in-person)

Treatment

Duration - 12 weeks

Participants with lower limb amputation conduct rehabilitation using the allocated prosthetic device (Lunaris® or SACH foot®) and perform daily activities with the prosthesis.

Rehabilitation period with routine care; assessments occur before and after this period

Post-treatment Assessment

Duration - Week 24

Participants undergo post-test assessments including MRI scans, functional performance tests, and questionnaires to evaluate changes after using the prosthetic device.

1 follow-up visit (in-person)

Trial Site Locations

Total: 1 location

1

Vrije Universiteit Brussel

Brussels, Belgium, 1050

Actively Recruiting

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Research Team

K

Kevin De Pauw

E

Elke Lathouwers

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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Published Research Related To This Trial

Impact of Course Configuration on 6-Minute Walk Test Performance of People with Lower Extremity Amputations.

Peter D Cox, Courtney A Frengopoulos, Susan W Hunter...

https://pubmed.ncbi.nlm.nih.gov/30275635

Comparison of mobility and user satisfaction between a microprocessor knee and a standard prosthetic knee: a summary of seven single-subject trials.

Charla L Howard, Chris Wallace, Bonnie Perry...

https://pubmed.ncbi.nlm.nih.gov/29293160

Step-to-step transition work during level and inclined walking using passive and powered ankle-foot prostheses.

Elizabeth Russell Esposito, Jennifer M Aldridge Whitehead, Jason M Wilken

https://pubmed.ncbi.nlm.nih.gov/25628378

Neuroplasticity Modifications Following a Lower-Limb Amputation: A Systematic Review.

Francisco Molina-Rueda, Cristian Navarro-Fernández, Alicia Cuesta-Gómez...

https://pubmed.ncbi.nlm.nih.gov/30989836

A systematic review of the diagnostic test accuracy of brief cognitive tests to detect amnestic mild cognitive impairment.

Seline Ozer, John Young, Claire Champ...

https://pubmed.ncbi.nlm.nih.gov/26891238

Exercise-induced neuroplasticity: Balance training increases cortical thickness in visual and vestibular cortical regions.

Ann-Kathrin Rogge, Brigitte Röder, Astrid Zech...

https://pubmed.ncbi.nlm.nih.gov/29959048

Biomechanical accommodation to walking with an ankle-foot prosthesis: An exploratory analysis of novice users with transtibial limb loss within the first year of ambulation.

Caitlin E Mahon, Brad D Hendershot

https://pubmed.ncbi.nlm.nih.gov/35333820