Trans-tibial Limb LossNCT02234505
Physiologic Range of Step-by-step Variations in Lower Limb Prosthesis Forces During Walking
A study testing Prosthetic alignment perturbation in people with Trans-tibial Limb Loss, run by University of Pittsburgh at 1 site in United States.
Trial summary
In human gait there is a certain amount of variation between steps; some considered physiological and owed to variations in environment or posture, and some severe enough to be indicative of gait instabilities that may lead to stumbling and falling. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trans-tibial Limb Loss
- What is being tested?
- Prosthetic alignment perturbation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Nov 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- activity classification of K2 to K4
- experience in prosthesis use of at least one year
- stated ability to walk pain free for at least 30 minutes
Who cannot join
- age of less than 18 years
- acute or ongoing residual limb pain
- use of a prosthesis that is not suitable for installation of the load cell (e.g. is too short, or has non-removable cosmesis)
Trial locations and contacts
1 site in 1 country.
United States1 site
Bakery Square MSPO labs
Pittsburgh, Pennsylvania, 15206
About this study
Official title: Physiologic Range of Step-by-step Variations in Lower Limb Prosthesis Forces
In human gait there is a certain amount of variation between steps; some considered physiological and owed to variations in environment or posture, and some severe enough to be indicative of gait instabilities that may lead to stumbling and falling. In users of lower limb prosthetics, such gait instabilities are of especially great interest.
The study investigates the correlation between socket alignment quality and gait step-by-step variability in users of trans-tibial-prosthetics. It is hypothesized that a clearly defined range of step-by-step variability exists, and that therefore step-by-step variability is suitable as an outcome variable for the assessment of socket alignment.
A sample of ten persons with trans-tibial amputation will be recruited for this pilot study. Subjects will be asked to walk on different natural surfaces while the socket alignment is successively perturbed. Step-by-step variations in horizontal ground reaction forces and torsional moments will be measured and statistically compared.
- Conditions
- Trans-tibial Limb Loss
- Being tested
- Prosthetic alignment perturbation
- Keywords
- prosthetics, amputation, gait stability, step variability, load cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosthetic alignment perturbationProcedure or surgery
Prosthetic ankle plantar-flexion will be modified in different degrees, devices (prosthetic components) will not be modified from baseline condition
| Study group | Role | What they receive |
|---|---|---|
| Trans-tibial prosthesis users | Experimental | prosthetic alignment perturbation Receives: Procedure: Prosthetic alignment perturbation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step-by-step variability
Peak horizontal ground reaction force (Fx and Fy) as well as peak axial torsion moment (Mz) will be extracted for 10 consecutive intermediary steps for each testing condition. Total range in Newtons over the 10 step sample, as well as maximal difference between consecutive steps in Newtons and percent will be reported for statistical analysis.
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 posted9 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionAug 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trans-tibial Limb LossStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- American Orthotic and Prosthetic Association
- Responsible party
- Principal investigator, Goeran Fiedler, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234505
- Sponsor's protocol ID
- PRO14040403
- Status last verified
- Dec 2015
- First submitted
- 28 Aug 2014
- Last updated
- 4 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic Range of Step-by-step Variations in Lower Limb Prosthesis Forces
- ClinicalTrials.gov ID
- NCT02234505
- Acronym / sponsor ID
- PRO14040403
- Conditions
- Trans-tibial Limb Loss
- Keywords
- prosthetics, amputation, gait stability, step variability, load cell
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- American Orthotic and Prosthetic Association
- Study start
- Sep 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 9 Sep 2014 (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.
In human gait there is a certain amount of variation between steps; some considered physiological and owed to variations in environment or posture, and some severe enough to be indicative of gait instabilities that may lead to stumbling and falling. In users of lower limb prosthetics, such gait instabilities are of especially great interest.
The study investigates the correlation between socket alignment quality and gait step-by-step variability in users of trans-tibial-prosthetics. It is hypothesized that a clearly defined range of step-by-step variability exists, and that therefore step-by-step variability is suitable as an outcome variable for the assessment of socket alignment.
A sample of ten persons with trans-tibial amputation will be recruited for this pilot study. Subjects will be asked to walk on different natural surfaces while the socket alignment is successively perturbed. Step-by-step variations in horizontal ground reaction forces and torsional moments will be measured and statistically compared.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trans-tibial prosthesis users | Experimental | Procedure: Prosthetic alignment perturbationprosthetic alignment perturbation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- activity classification of K2 to K4
- experience in prosthesis use of at least one year
- stated ability to walk pain free for at least 30 minutes
Key exclusion criteria (3 listed)
- age of less than 18 years
- acute or ongoing residual limb pain
- use of a prosthesis that is not suitable for installation of the load cell (e.g. is too short, or has non-removable cosmesis)
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 alignment perturbationProsthetic ankle plantar-flexion will be modified in different degrees, devices (prosthetic components) will not be modified from baseline condition | Procedure or surgery | Trans-tibial prosthesis users |
Primary outcome
Step-by-step variability
Time frame: 2 hours
Peak horizontal ground reaction force (Fx and Fy) as well as peak axial torsion moment (Mz) will be extracted for 10 consecutive intermediary steps for each testing condition. Total range in Newtons over the 10 step sample, as well as maximal difference between consecutive steps in Newtons and percent will be reported for statistical analysis.
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 Dec 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prosthetic alignment perturbation in people with Trans-tibial Limb Loss, run by University of Pittsburgh at 1 site in United States.
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 3 inclusion and 3 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 Dec 2015. 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 United States. 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?
Step-by-step variability (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 4 Dec 2015.