AmputationNCT06156839
Junior LP Foot - Clinical Investigation Protocol
A study testing Prosthetic Foot in people with Amputation, run by Össur Iceland ehf.
Trial summary
The purpose of the following study is of exploratory nature to provide design input for a prosthetic foot under development for children with lower limb loss, amputation or deficiency. Read more about this study
- Who is it for?
- Ages 5 to 21 years
- Conditions the study is for
- Amputation
- What is being tested?
- Prosthetic Foot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- 8 Jan 2024to 10 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Cognitive ability to understand all instructions and questionnaires in the study (adapted to kids).
- Active prosthesis user
- Transtibial or transfemoral amputation, limb loss or similar level congenital limb deficiency.
- Age 5 or older.
- o Age 5-12 years preferred.
- 15 kg < Body weight < 55 kg
Show all 9Show fewer
- 16 ≤ Foot size ≤ 24
- Clearance: Size 16 > 50mm, Sizes 17-19 > 60mm, Sizes 20-24 > 70mm
- Willing and able to participate in the study and follow the protocol, including consent to participate from legal guardian if under 16 years old.
Who cannot join
- Users with severe residual limb pain or socket problems, which have negative impact on testing and outcome.
About this study
Official title: Exploratory Testing of a Pediatric Foot
The purpose of the following study is of exploratory nature to provide design input for a prosthetic foot under development for children with lower limb loss, amputation or deficiency.
Read the detailed description
The purpose of the following study is of exploratory nature to provide design input for a prosthetic foot under development for children with lower limb loss, amputation or deficiency.
User testing is needed to get data points for the stiffness curve of the foot. These datapoints are extrapolated from user testing and reduces the risk to design a too stiff or soft device.
Machine tests cannot replace user feedback. The user´s perception helps to detect performance deficits and address these in early stages of the design.
Walking performance may change if the foot is too stiff or too soft. Some of these changes can be spotted by observation through legal guardians or experienced prosthetists. Product changes may be justified based on the observations made by the child, legal guardian, Certified Prosthetist/Orthotist (CPO) or engineers specializing in foot design.
- Conditions
- Amputation
- Being tested
- Prosthetic Foot
- Keywords
- Prosthetic Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosthetic FootDevice
Stiffness Testing Procedure:
- Potential subjects identified, fitting inclusion/exclusion criteria, by Principle Investigator (PI).
- Informed consent obtained from participant if applicable, legal guardian or both.
- Subject (legal guardian) signs Informed Consent Form (ICF)
- Subject ambulates on their current prescribed foot for observation - Questions administered, by PI or delegated by PI
- Subject fitted with investigational device, by PI
- Subject ambulates in the investigational device for observation - Questions administered, by PI or delegated by PI
- Subject is fitted back to their prescribed prosthesis, by PI
| Study group | Role | What they receive |
|---|---|---|
| Prosthetic Foot - Stiffness Testing | Experimental | Test prosthetic feet with different stiffness properties. Receives: Device: Prosthetic Foot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Prosthetic Foot Stiffness
User perception of provided prosthetic foot stiffness. Too soft good Too stiff
Measured: 2 hours
Secondary outcomes (1)
Overall Prosthetic Foot Performance
User perception of provided prosthetic foot performance.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start8 Jan 2024
- Primary completion15 Apr 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Össur Iceland ehf
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shriners Hospitals for Children
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156839
- Sponsor's protocol ID
- CIP2023101939
- Status last verified
- Oct 2025
- First submitted
- 17 Nov 2023
- Last updated
- 16 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Testing of a Pediatric Foot
- ClinicalTrials.gov ID
- NCT06156839
- Acronym / sponsor ID
- CIP2023101939
- Conditions
- Amputation
- Keywords
- Prosthetic Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Össur Iceland ehfIndustry (pharma, biotech, devices)
- Collaborators
- Shriners Hospitals for Children
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 5 Dec 2023 (actual)
- Results
- Posted 16 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the following study is of exploratory nature to provide design input for a prosthetic foot under development for children with lower limb loss, amputation or deficiency.
Detailed description
The purpose of the following study is of exploratory nature to provide design input for a prosthetic foot under development for children with lower limb loss, amputation or deficiency.
User testing is needed to get data points for the stiffness curve of the foot. These datapoints are extrapolated from user testing and reduces the risk to design a too stiff or soft device.
Machine tests cannot replace user feedback. The user´s perception helps to detect performance deficits and address these in early stages of the design.
Walking performance may change if the foot is too stiff or too soft. Some of these changes can be spotted by observation through legal guardians or experienced prosthetists. Product changes may be justified based on the observations made by the child, legal guardian, Certified Prosthetist/Orthotist (CPO) or engineers specializing in foot design.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prosthetic Foot - Stiffness Testing | Experimental | Device: Prosthetic FootTest prosthetic feet with different stiffness properties. |
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Cognitive ability to understand all instructions and questionnaires in the study (adapted to kids).
- Active prosthesis user
- Transtibial or transfemoral amputation, limb loss or similar level congenital limb deficiency.
- Age 5 or older.
- o Age 5-12 years preferred.
Key exclusion criteria (1 listed)
- Users with severe residual limb pain or socket problems, which have negative impact on testing and outcome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prosthetic FootStiffness Testing Procedure: * Potential subjects identified, fitting inclusion/exclusion criteria, by Principle Investigator (PI). * Informed consent obtained from participant if applicable, legal guardian or both. * Subject (legal guardian) signs Informed Consent Form (ICF) * Subject ambulates on their current prescribed foot for observation - Questions administered, by PI or delegated by PI * Subject fitted with investigational device, by PI * Subject ambulates in the investigational device for observation - Questions administered, by PI or delegated by PI * Subject is fitted back to their prescribed prosthesis, by PI | Device | Prosthetic Foot - Stiffness Testing |
Primary outcome
Overall Prosthetic Foot Stiffness
Time frame: 2 hours
User perception of provided prosthetic foot stiffness. Too soft good Too stiff
1 secondary outcome
Overall Prosthetic Foot Performance
Time frame: 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Prosthetic Foot in people with Amputation, run by Össur Iceland ehf.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Prosthetic Foot Stiffness (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.