Human-Prosthetic Interaction: Brain & Technology After Lower-Limb Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVrije Universiteit Brussel
About this trial
This study evaluates brain neuroplasticity and functional performance in people with unilateral lower limb amputation.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Unilateral transtibial (below knee) amputation
Healthy subject
Medicare Functional Classification Level: K3-4
Disqualifiers
Any neurological disease
Upper limb or bilateral amputation
Osso-integration
Metal implants
Trial design
Design model
Single group
Treatments tested in this trial
Prosthetic device (Lunaris)
DeviceParticipants with an amputation will conduct experiments with the prosthetic device
No prosthetic device
Other interventionAble-bodied individuals will conduct experiments to enable comparison with the participants with amputation
Prosthetic device (Sach foot)
DeviceParticipants with an amputation will conduct experiments with the prosthetic device
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: New prosthesisExperimental treatment 1 intervention
Group B: Standard prosthesisActive comparator 1 intervention
Group C: Control group of able-bodied individualsOther 1 intervention
Trial outcomes
Primary outcomes
1
Brain neuroplasticity
Brain scan: diffusion-weighted imaging
Time frame
Change over 24 weeksSecondary outcomes
1
Performance
time (seconds) to complete L-test
Time frame
Change over 12 weeks2
Performance
time (seconds) to complete dual-L test
Time frame
Change over 12 weeks3
Performance
time (seconds) to complete slope walking test
Time frame
Change over 12 weeks4
Performance
time (seconds) to complete stair climbing test
Time frame
Change over 12 weeksSponsors and contacts
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Source ClinicalTrials.gov