NCT05818410

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Vrije Universiteit Brussel · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study evaluates brain neuroplasticity and functional performance in people with unilateral lower limb amputation.

Detailed description

The researchers will investigate the beneficial effect of a passive prosthetic ankle (Lunaris®) on functional physical performance, brain neuroplasticity and movement patterns compared to conventional prosthetic feet and able-bodied individuals. The clinical trial will comprise four test days for participants with a lower limb amputation and two days for the control group of able-bodied individuals. The able-bodied individuals will undergo an MRI scan at the University Hospital Brussels (dpt. Radiology and Magnetic Resonance) and perform functional performance tests. Participants with a lower limb amputation will start the clinical trial upon the start of their rehabilitation. At week 0, when initiating the rehabilitation, participants will undergo a baseline MRI scan at the University Hospital Brussels (dpt. Radiology and Magnetic Resonance). Then, they will be allocated to the intervention arms (Lunaris® or the SACH foot®) and will conduct their rehabilitation to learn to walk with a prosthesis. At the end of the rehabilitation, after 12 weeks, participants will perform baseline functional performance tests, fill out the prosthetic evaluation questionnaire (PEQ) measuring the quality of life. Between weeks 12 and 24 of the clinical trial (i.e. intervention period), participants will perform their daily activities with the allocated prosthesis. During weeks 12 - 24, trying out new prosthetic devices will be allowed within the group of individuals wearing the SACH foot® as this is considered the usual care. At the end of this period (after week 24), the post-test assessment will take place and participants will undergo the same MRI and functional performance tests and fill out the PEQ as during the baseline assessments to evaluate the changes that occurred. Additionally, participants will be asked to fill out the Quebec User Evaluation of Satisfaction with Assistive Technology. The 12-week intervention period is chosen based on a study examining the effect of 12 weeks of balance training in healthy and older adults on neuroplasticity and the accommodation time to walking with a new prosthesis.

Conditions

• Lower Limb Amputation Below Knee (Injury)

Interventions

Type	Name	Description
DEVICE	Prosthetic device (Lunaris)	Participants with an amputation will conduct experiments with the prosthetic device
OTHER	No prosthetic device	Able-bodied individuals will conduct experiments to enable comparison with the participants with amputation
DEVICE	Prosthetic device (Sach foot)	Participants with an amputation will conduct experiments with the prosthetic device

Timeline

• Start date: 2024-01-16
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2023-04-18
• Last updated: 2025-02-24

Locations

1 site across 1 country: Belgium