Evaluation of Validity and Reliability of Inertial Measurement Unit-Based Gait Analysis Systems.
Young-Shin Cho, Seong-Ho Jang, Jae-Sung Cho...
https://pubmed.ncbi.nlm.nih.gov/30613081/Actively Recruiting
Led by Vrije Universiteit Brussel · Updated on 2025-02-24
60
Participants Needed
1
Research Sites
N/A
Total Duration
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
Human-Prosthetic Interaction: Brain & Technology After Lower-Limb Loss
K
Kevin De Pauw
E
Elke Lathouwers
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Vrije Universiteit Brussel
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
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)
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
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)
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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Lead Sponsor