Amputation; Traumatic, Leg, Lower, Between Knee and AnkleProStoNCT03046394
Comparison Between Three Types of Prosthetic Feet
A study testing C-SACH, B-DER and A-DER in people with Amputation; Traumatic, Leg, Lower, Between Knee and Ankle, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
Trial summary
One Solid Ankle Cushion Heel (SACH) and two Dynamic Elastic Response (DER) prosthetic feet will be tried six times in random order by the patient. The patient will be an active prosthetic foot user who walks several kilometers per day and was amputated at the trans-tibial level because of injury. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men only
- Conditions the study is for
- Amputation; Traumatic, Leg, Lower, Between Knee and Ankle
- What is being tested?
- C-SACH, B-DER and A-DER
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteSlovenia
- Study dates
- 6 Feb 2017to 3 May 2017
- Phase
- Interventional
- 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 20 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- active prosthetic foot user who walks several kilometers per day
- amputation at the trans-tibial level >5 years ago
Who cannot join
- other medical problems
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University Rehabilitation Institute, Republic of Slovenia
Ljubljana, 1000
About this study
Official title: Comparison Between Three Types of Prosthetic Feet: a Randomized Double-blind Controlled Single-subject Multiple-rater Trial
One Solid Ankle Cushion Heel (SACH) and two Dynamic Elastic Response (DER) prosthetic feet will be tried six times in random order by the patient. The patient will be an active prosthetic foot user who walks several kilometers per day and was amputated at the trans-tibial level because of injury. Gait pattern will be rated in comparison with the patient's previous prosthetic foot by a physiatrist, physiotherapist, prosthetist and the patient. One-leg standing and 10-meter walking tests will also be performed.
Read the detailed description
The prosthetic feet will be: one SACH foot (by Otto Bock - foot C, advertised for activity category 1) and two DER feet (Dynamic Motion by Otto Bock - foot B, advertised for activity category 2-3; and Triton by Otto Bock - foot A, advertised for activity category 3-4).
All the prosthetic feet are of the same size and chosen for the patient's weight. They will be covered so that neither the patient nor professionals will be able to see which prosthetic foot is being used.
The study is blinded because the prosthetist designated for changing the prosthetic feet will be the only one who will know which prosthetic is being used. The orientational sample size calculation and the randomisation plan were prepared by a statistician.
The first trial will be performed using the patient's own prosthetic foot in order to establish a baseline. The patient will then have to to compare the prosthetic feet with his own existing prosthetic foot and rate the ability to walk on even terrain (100m), uneven terrain (grass, 100m), decline and incline (i.e., slope), and up and down the stairs (one floor) on a five-point Likert-type scale (-2 much worse, -1 slightly worse, 0 the same, 1 slightly better, 2 much better). After each trial he will also perform the one-leg standing test (with three repetitions) and the 10-meter walking test. Before each trial, the patient will be given 15 minutes for adaptation to each new prosthetic foot without the presence of the assessors.
The three expert observers will be: a physical and rehabilitation medicine specialist physician, a certified prosthetist-orthotist, and a physiotherapist. Each has got over 20 years of experience in rehabilitation of patients after amputation and observation of their gait. They will be blind to the currently used prosthetic foot. They will follow the patient and assess his walking using the same rating scale in comparison with the initial trial as the patient.
- Being tested
- C-SACH, B-DER, A-DER
- Keywords
- prosthetic feet, gait pattern, one leg standing, walking speed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-SACHDevice
Solid Ankle Cushion Heel by Otto Bock, advertised for activity category 1
B-DERDevice
Dynamic Motion by Otto Bock, advertised for activity category 2-3
A-DERDevice
Triton by Otto Bock, advertised for activity category 3-4
| Study group | Role | What they receive |
|---|---|---|
| C-SACH | Active comparator | All the interventions will be administered to the patient in this single-subject trial, each 6 times Receives: Device: C-SACH |
| B-DER | Active comparator | All the interventions will be administered to the patient in this single-subject trial, each 6 times Receives: Device: B-DER |
| A-DER | Active comparator | All the interventions will be administered to the patient in this single-subject trial, each 6 times Receives: Device: A-DER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rating
Likert-type, compared to the patient's existing prosthetic foot (-2 much worse, -1 slightly worse, 0 the same, 1 slightly better, 2 much better)
Measured: Immediately after each trial
Secondary outcomes (2)
The time that the patient can stand on the prosthetic foot
Measured by the one-leg standing test (average of three repetitions)
Measured: Immediately after the rating, repeated 3 times
Walking velocity
Measured by the 10-meter walking test
Measured: Immediately after the one-leg standing test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start6 Feb 2017
- Primary completion10 Feb 2017
- Study completion3 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation; Traumatic, Leg, Lower, Between Knee and AnkleStudies 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
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rehabilitation Institute, Republic of Slovenia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helena Burger, MD, PhD, Principal investigator, University Rehabilitation Institute, Republic of Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046394
- Sponsor's protocol ID
- URIS201701
- Acronym
- ProSto
- Status last verified
- May 2017
- First submitted
- 6 Feb 2017
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Three Types of Prosthetic Feet: a Randomized Double-blind Controlled Single-subject Multiple-rater Trial
- ClinicalTrials.gov ID
- NCT03046394
- Acronym / sponsor ID
- ProSto / URIS201701
- Keywords
- prosthetic feet, gait pattern, one leg standing, walking speed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Rehabilitation Institute, Republic of SloveniaUniversity, hospital or other
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 10 Feb 2017 (actual)
- Study completion
- 3 May 2017 (actual)
- First posted
- 8 Feb 2017 (estimated)
- 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.
One Solid Ankle Cushion Heel (SACH) and two Dynamic Elastic Response (DER) prosthetic feet will be tried six times in random order by the patient. The patient will be an active prosthetic foot user who walks several kilometers per day and was amputated at the trans-tibial level because of injury. Gait pattern will be rated in comparison with the patient's previous prosthetic foot by a physiatrist, physiotherapist, prosthetist and the patient. One-leg standing and 10-meter walking tests will also be performed.
Detailed description
The prosthetic feet will be: one SACH foot (by Otto Bock - foot C, advertised for activity category 1) and two DER feet (Dynamic Motion by Otto Bock - foot B, advertised for activity category 2-3; and Triton by Otto Bock - foot A, advertised for activity category 3-4).
All the prosthetic feet are of the same size and chosen for the patient's weight. They will be covered so that neither the patient nor professionals will be able to see which prosthetic foot is being used.
The study is blinded because the prosthetist designated for changing the prosthetic feet will be the only one who will know which prosthetic is being used. The orientational sample size calculation and the randomisation plan were prepared by a statistician.
The first trial will be performed using the patient's own prosthetic foot in order to establish a baseline. The patient will then have to to compare the prosthetic feet with his own existing prosthetic foot and rate the ability to walk on even terrain (100m), uneven terrain (grass, 100m), decline and incline (i.e., slope), and up and down the stairs (one floor) on a five-point Likert-type scale (-2 much worse, -1 slightly worse, 0 the same, 1 slightly better, 2 much better). After each trial he will also perform the one-leg standing test (with three repetitions) and the 10-meter walking test. Before each trial, the patient will be given 15 minutes for adaptation to each new prosthetic foot without the presence of the assessors.
The three expert observers will be: a physical and rehabilitation medicine specialist physician, a certified prosthetist-orthotist, and a physiotherapist. Each has got over 20 years of experience in rehabilitation of patients after amputation and observation of their gait. They will be blind to the currently used prosthetic foot. They will follow the patient and assess his walking using the same rating scale in comparison with the initial trial as the patient.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| C-SACH | Active comparator | Device: C-SACHAll the interventions will be administered to the patient in this single-subject trial, each 6 times |
| B-DER | Active comparator | Device: B-DERAll the interventions will be administered to the patient in this single-subject trial, each 6 times |
| A-DER | Active comparator | Device: A-DERAll the interventions will be administered to the patient in this single-subject trial, each 6 times |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- active prosthetic foot user who walks several kilometers per day
- amputation at the trans-tibial level >5 years ago
Key exclusion criteria (1 listed)
- other medical problems
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 |
|---|---|---|
| C-SACHSolid Ankle Cushion Heel by Otto Bock, advertised for activity category 1 | Device | C-SACH |
| B-DERDynamic Motion by Otto Bock, advertised for activity category 2-3 | Device | B-DER |
| A-DERTriton by Otto Bock, advertised for activity category 3-4 | Device | A-DER |
Primary outcome
Rating
Time frame: Immediately after each trial
Likert-type, compared to the patient's existing prosthetic foot (-2 much worse, -1 slightly worse, 0 the same, 1 slightly better, 2 much better)
2 secondary outcomes
The time that the patient can stand on the prosthetic foot
Time frame: Immediately after the rating, repeated 3 times
Walking velocity
Time frame: Immediately after the one-leg standing test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- 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.
Helena Burger, MD, PhD principal investigator
University Rehabilitation Institute, Republic of Slovenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-SACH, B-DER and A-DER in people with Amputation; Traumatic, Leg, Lower, Between Knee and Ankle, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
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 2 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 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rating (time frame: Immediately after each trial). 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 4 May 2017; AzTrials last refreshed its copy on 1 Nov 2026.