Assessing the load on prosthetic limbs for individuals with limb loss
Biomechanical Assessment of Load Applied on Residuum of Individuals With Limb Loss Fitted With a Prosthetic Limb
This study is testing how different bionic prosthetic knees affect the way people with leg amputations feel and move during everyday activities like walking and cycling.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | YourResearchProject Pty Ltd Industry-sponsored |
| Locations | 1 site (Bardon, Queensland) |
| Trial ID | NCT05870267 on ClinicalTrials.gov |
What this trial studies
This observational study aims to perform biomechanical analyses of the load applied on the residuum of individuals with transfemoral limb loss who are fitted with bionic bone-anchored prostheses. Participants will engage in common daily activities, such as walking and cycling, while their prosthetic loading will be measured. The study will involve 30 participants and will compare the efficacy and safety of different prosthetic devices, including the Power Knee and other microprocessor-controlled knees. Data will be collected through a cross-sectional cohort design, focusing on the forces and moments experienced during these activities.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-80 with a lower limb amputation for more than 12 months who can walk independently and meet specific health criteria.
Not a fit: Patients who have bilateral amputations or self-reported pain levels greater than 4 out of 10 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prosthetic designs that enhance the safety and functionality for individuals with limb loss.
How similar studies have performed: While similar biomechanical assessments have been conducted, this specific approach focusing on bionic bone-anchored prostheses is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * be willing to participate to this project of research, * be able to be fitted with common bionic prosthetic components (e.g., Knee, feet), * be willing to comply with protocol, * have a lower limb amputation more than 12 months prior testing, * have a clearance of at least 6 cm between residuum and prosthetic joint, * have completed rehabilitation program, * be free of injuries on the day of the recording session, * weigh less than 121 kg, * be able to walk 200 meters independently, * be between 18-80 years of age. Exclusion Criteria: * not be able to give informed consent, * have bilateral amputation, * have self-reported pain levels greater than 4 out of 10 at study outset, * have experienced a fall within the last 8 weeks before assessment, * have mental illness or intellectual impairment, * have injuries involving contralateral (intact) limb, * have major uncorrected visual deficit, * have history of epilepsy or recurrent dizziness, * present signs of infection 2 weeks prior testing session.
Where this trial is running
Bardon, Queensland
- YourResearchProject Pty Ltd — Bardon, Queensland, Australia (Recruiting)
Study contacts
- Principal investigator: Laurent Frossard, PhD — YourResearchProject Pty Ltd
- Study coordinator: Lisa Tronicke, M.Sc.
- Email: ltronicke@ossur.com
- Phone: 15155367970
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.