Testing of Methodology of Attachment of External Foot Prothesis Based on Anthropomorphism CriteriaNCT05411601
Numerical Standard of Anthropomorphicity of Prosthetic Feet for Improvement of Amputee Performance
An observational study of Testing of Methodology of Attachment of External Foot Prothesis Based on Anthropomorphism Criteria, run by PolyOrth International.
Trial summary
The study concerns the testing of methodology of attachment of external foot prothesis based on anthropomorphism criteria Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Testing of Methodology of Attachment of External Foot Prothesis Based on Anthropomorphism Criteria
- What is being tested?
- Methodology of attachment of external foot prothesis
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2022to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- Adult
Study population: Subjects 18-60 years old that underwent unilateral lower transtibial amputation
Who may be able to join
- Unilateral lower transtibial amputation
- Prosthetic user with socket type attachment (Cohort 1) or with direct skeletal attachment (Cohort 2) and be able to walk 50 meters independently,
- Between 18-60 years of age,
- Able to follow instructions,
- Able to provide consent.
Who cannot join
- problems on the residuum,
- Non-prosthetic user,
- Bilateral amputation,
- Self-reported pain levels greater than 4 out of 10 at study outset,
- Experienced a fall within the last 8 weeks before assessment,
- Mental illness or intellectual impairment compromising participant's ability to give informed consent,
Show all 9Show fewer
- Injuries involving contralateral (intact) limb,
- Major uncorrected visual deficit,
- History of epilepsy or recurrent dizziness,
Trial locations and contacts
No sites are listed yet.
About this study
The study concerns the testing of methodology of attachment of external foot prothesis based on anthropomorphism criteria
- Conditions
- Testing of Methodology of Attachment of External Foot Prothesis Based on Anthropomorphism Criteria
- Being tested
- Methodology of attachment of external foot prothesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methodology of attachment of external foot prothesisOther
establishing the methodology of specific measurements of attachment of external foot prothesis
| Study group | Role | What they receive |
|---|---|---|
| C1 | Subjects with socket-type attachment of their prostheses Receives: Other: Methodology of attachment of external foot prothesis | |
| C2 | Subjects with direct skeletal attachment Receives: Other: Methodology of attachment of external foot prothesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stiffness and the index of anthropomorphicity IAm
Range of ankle stiffnesses, including three prostheses currently recommended to patients with direct skeletal attachment
Measured: 30 days
IAb of the selected prosthetic feet
To establish IAb of the selected prosthetic feet via biomechanical gait testing
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start30 Sep 2022 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testing of Methodology of Attachment of External Foot Prothesis Based on Anthropomorphism CriteriaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PolyOrth International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411601
- Sponsor's protocol ID
- POI 012022
- Status last verified
- Jun 2022
- First submitted
- 6 Jun 2022
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Numerical Standard of Anthropomorphicity of Prosthetic Feet for Improvement of Amputee Performance
- ClinicalTrials.gov ID
- NCT05411601
- Acronym / sponsor ID
- POI 012022
- Conditions
- Testing of Methodology of Attachment of External Foot Prothesis Based on Anthropomorphism Criteria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- PolyOrth InternationalIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2022 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study concerns the testing of methodology of attachment of external foot prothesis based on anthropomorphism criteria
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C1 | – | Other: Methodology of attachment of external foot prothesisSubjects with socket-type attachment of their prostheses |
| C2 | – | Other: Methodology of attachment of external foot prothesisSubjects with direct skeletal attachment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Subjects 18-60 years old that underwent unilateral lower transtibial amputation
Key inclusion criteria (5 listed)
- Unilateral lower transtibial amputation
- Prosthetic user with socket type attachment (Cohort 1) or with direct skeletal attachment (Cohort 2) and be able to walk 50 meters independently,
- Between 18-60 years of age,
- Able to follow instructions,
- Able to provide consent.
Key exclusion criteria (9 listed)
- problems on the residuum,
- Non-prosthetic user,
- Bilateral amputation,
- Self-reported pain levels greater than 4 out of 10 at study outset,
- Experienced a fall within the last 8 weeks before assessment,
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 |
|---|---|---|
| Methodology of attachment of external foot prothesisestablishing the methodology of specific measurements of attachment of external foot prothesis | Other | C1, C2 |
Primary outcome
Stiffness and the index of anthropomorphicity IAm
Time frame: 30 days
Range of ankle stiffnesses, including three prostheses currently recommended to patients with direct skeletal attachment
IAb of the selected prosthetic feet
Time frame: 30 days
To establish IAb of the selected prosthetic feet via biomechanical gait testing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Testing of Methodology of Attachment of External Foot Prothesis Based on Anthropomorphism Criteria, run by PolyOrth International.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 9 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Pitkin, PhD (339-364-1955, Mark Pitkin <m.pitkin@yahoo.com>), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stiffness and the index of anthropomorphicity IAm (time frame: 30 days). The study lists 2 primary outcomes in all. 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 9 Jun 2022.