Amputation
Conditions
Keywords
Prosthetic Device
Brief 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.
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.
Interventions
DEVICEProsthetic Foot
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
Sponsors
Össur Iceland ehf
Shriners Hospitals for Children
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* 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 * 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.
Exclusion criteria
* Users with severe residual limb pain or socket problems, which have negative impact on testing and outcome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Prosthetic Foot Stiffness | 2 hours | User perception of provided prosthetic foot stiffness. Too soft good Too stiff |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Prosthetic Foot Performance | 2 hours | User perception of provided prosthetic foot performance. |
Participant flow
Recruitment details
Recruitment took place between January and March 2024, participants recruited from clinic database.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 12 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Region of Enrollment United States | 13 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 7 Participants |
| Weight | 38.3 kilogram STANDARD_DEVIATION 12 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
None listed