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| Name | Class |
|---|---|
| Shriners Hospitals for Children | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prosthetic Foot - Stiffness Testing | Experimental | Test prosthetic feet with different stiffness properties. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prosthetic Foot | Device | Stiffness Testing Procedure:
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Prosthetic Foot Stiffness | User perception of provided prosthetic foot stiffness. Too soft good Too stiff | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Prosthetic Foot Performance | User perception of provided prosthetic foot performance. | 2 hours |
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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:
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Recruitment took place between January and March 2024, participants recruited from clinic database.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prosthetic Foot - Stiffness Testing | Test prosthetic feet with different stiffness properties. Prosthetic Foot: Stiffness Testing Procedure:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prosthetic Foot - Stiffness Testing | Test prosthetic feet with different stiffness properties. Prosthetic Foot: Stiffness Testing Procedure:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Prosthetic Foot Stiffness | User perception of provided prosthetic foot stiffness. Too soft good Too stiff | Posted | Number | participants | 2 hours |
|
1 week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prosthetic Foot - Stiffness Testing | Test prosthetic feet with different stiffness properties. Prosthetic Foot: Stiffness Testing Procedure:
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Volker Nissels | Össur Iceland ehf. | +49 15111324706 | vnissels@ossur.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 2, 2024 | Mar 12, 2026 | Prot_SAP_001.pdf |
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|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | kilogram |
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| Secondary | Overall Prosthetic Foot Performance | User perception of provided prosthetic foot performance. | Posted | Count of Participants | Participants | 2 hours |
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| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
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