Transtibial Amputation - UnilateralNCT02542761
Comparative Performance of Dynamic Elastic Response Feet
A study testing Fiberglass Composite foot and Carbon Fiber Composite Foot in people with Transtibial Amputation - Unilateral, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study was to compare the functional performance of individuals with transtibial amputation using two types of prosthetic foot designs: carbon fiber vs. fiberglass composite. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Transtibial Amputation - Unilateral
- What is being tested?
- Fiberglass Composite foot and Carbon Fiber Composite Foot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral transtibial amputee
- Currently using a carbon fiber prosthetic (DER) foot for at least the last 6 months
- Stable stump volume over the past 6 months
- Medicare Functional Classification Level K3 or K4
Who cannot join
- Neuromuscular problems such as previous stroke or contralateral amputation
- Use of gait aids for ambulation
- Undergoing dialysis
- Poor prosthetic socket fit or stump problems (e.g., skin breakdown)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to compare the functional performance of individuals with transtibial amputation using two types of prosthetic foot designs: carbon fiber vs. fiberglass composite.
Read the detailed description
Recently, a new type of prosthetic foot has appeared on the market. This device is composed of a fiberglass composite material. Knowledge is lacking regarding the performance characteristics of this new device. Comprehensive studies are needed to form a solid basis for prosthetic prescription. The current study sought to understand the experience of community-living, transtibial amputees using this prosthetic foot. Specifically, the biomechanical performance of this device were compared to existing conventional dynamic elastic response (DER) technology in a controlled laboratory setting. The investigators hypothesized that the fiberglass composite material provided more energy return and improved ankle kinematics performance.
The study design was a repeated measures cross-over trial whereby only the prosthetic foot was changed. Each subject was tested using their current carbon-fiber energy storage and return prosthetic foot (CFPF) and the fiberglass composite energy storage and return prosthetic foot (Rush, Ability Dynamics) (FPF). Half of the subjects began the study on the CFPF while the other half began on the FPF. All types of CFPF were used in this study. Each subject was given an acclimation period (about 4 weeks) before testing, which was consistent with other similar studies. The same socket and suspension were used throughout the study in order to eliminate these confounding variables.
A 10 camera, high resolution motion capture system with a set of 51 reflective markers was used to capture whole-body motion. Three-dimensional marker trajectory data was collected at 120 Hz and filtered using a fourth-order Butterworth low-pass filter with a cutoff frequency of 8 Hz. The standard Helen Hayes marker set and some additional markers were applied to the subject. Additional markers included an anterior pylon marker, medial pylon marker, lateral pylon marker, right and left medial calcaneus markers, and right and left lateral calcaneus markers. In addition, left and right medial knee markers were used for establishing the knee joint centers and were then removed for the walking trails. Subjects wore standard laboratory athletic shoes for all walking trials. All of the markers associated with the foot were placed on the outside of the subject's shoes.
Following the application of the reflective marker set, the subject performed tests while walking over level ground at a self-selected and normalized speed as well as up and down a 10 degree inclined ramp. The normalized speed controlled for leg length by normalizing to a Froude (Fr) number of 0.25 where Fr = v^2/gl, and v is the walking speed, g is the gravitational constant, and l is the leg length using the greater trochanter height as leg length. Timing gates were used to control the walking speed. Simultaneously, ground reaction force data was collected from force plates at a sampling rate of 600 Hz. Data from these force plates was time-synchronized with the motion cameras. The ramp had a force plate embedded within the ramp.
- Conditions
- Transtibial Amputation - Unilateral
- Being tested
- Fiberglass Composite foot, Carbon Fiber Composite Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiberglass Composite footDevice
Also called Rush Foot
The Rush foot is a fiberglass composite energy storage and return prosthetic foot.
Carbon Fiber Composite FootDevice
Also called Otto Bock Triton, Ossur Variflex, Ossur Variflex EVO, Ossur Reflex Shock
All types of currently commercially available carbon fiber energy storage and return prosthetic feet will be considered appropriate.
| Study group | Role | What they receive |
|---|---|---|
| CFPF first, then FPF | Experimental | After a 4 week acclimation period, subjects were studied on their current carbon fiber composite foot (CFPF), followed by another 4 week acclimation period, then studied on the study provided fiberglass composite foot (FPF). Receives: Device: Fiberglass Composite foot; Device: Carbon Fiber Composite Foot |
| FPF first, then CFPF | Experimental | After a 4 week acclimation period, subjects were studied on the study provided fiberglass composite foot (FPF), followed by another 4 week acclimation period, then studied on their current carbon fiber composite foot (CFPF). Receives: Device: Fiberglass Composite foot; Device: Carbon Fiber Composite Foot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Ankle Dorsiflexion During Stance
The peak ankle dorsiflexion is the peak ankle backward flexion or bending when walking.
Measured: After approximate 4 week acclimation period
Secondary outcomes (5)
Peak Ankle Plantar Flexor Moment During Stance
Peak ankle plantar flexor moment means the peak force of the movement of the foot in which the foot or toes flex downward toward the sole. The unit of measurement for this variable is Nm/kg = 1 nanometer / (kilogram unit).
Measured: After approximate 4 week acclimation period
Peak Ankle Power Generation
Joint power (P) is the "dot product" of the moment (M) at the joint and the angular velocity (w) of the distal segment with respect to the proximal segment (i.e., P = M · w). Depending on the direction of the moment and the direction of the angular velocity, the power can be positive or negative. If the signs for the moment and angular velocity are both positive or both negative, the power is positive. If the signs for the moment and angular velocity are different, the power is negative. The unit of measurement for this variable is W/kg = watts/kilogram.
Measured: After approximate 4 week acclimation period
Peak Knee Flexion During Swing
A gait cycle is the period of time for one stride, that is, the time from one event (usually initial foot contact) to the next occurrence of the same event with the same foot. For each leg, the gait cycle can be divided into a stance phase and a swing phase. This variable is measuring the angle of knee flexion during the swing phase.
Measured: After approximate 4 week acclimation period
Time of Peak Knee Flexion During Swing
A gait cycle is the period of time for one stride, that is, the time from one event (usually initial foot contact) to the next occurrence of the same event with the same foot. For each leg, the gait cycle can be divided into a stance phase and a swing phase. This variable is expressed as a percentage of the gait cycle.
Measured: After approximate 4 week acclimation period
Patient Satisfaction as Measured by the Prosthesis Evaluation Questionnaire (PEQ)
The PEQ is a self-administered questionnaire composed of nine scales computed from forty-two items (ambulation, appearance, frustration, perceived response, residual limb health, social burden, sounds, utility, well being). Each question uses a visual analog scale format, scored as a continuous numerical variable measured as the distance in millimeters from the left endpoint of the measured from the left (0-100). The 0 side of the scale is very negative (terrible) and the 100 side of the scale is very positive (excellent). Each scale is reported separately, with a higher score indicating more satisfaction with the prosthesis itself or quality of life.
Measured: After approximate 4 week acclimation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transtibial Amputation - UnilateralStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- This was a repeated measures cross-over trial whereby only the prosthetic foot was changed. Each subject was tested using their current carbon-fiber prosthetic foot (CFPF), and the fiberglass prosthetic foot (FPF). Half of the subjects began the study on the CFPF while the other half began on the FPF. Each subject was given an acclimation period of 4 weeks before testing.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenton R. Kaufman, Ph.D., Mayo Clinic
- Investigators
- Kenton R Kaufman, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542761
- Sponsor's protocol ID
- 15-001367
- Status last verified
- Aug 2018
- First submitted
- 15 Jun 2015
- Last updated
- 20 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Kaufman KR, Bernhardt K. Functional performance differences between carbon fiber and fiberglass prosthetic feet. Prosthet Orthot Int. 2021 Jun 1;45(3):205-213. doi: 10.1097/PXR.0000000000000004.
PubMed 33856155
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Performance of Dynamic Elastic Response Feet
- ClinicalTrials.gov ID
- NCT02542761
- Acronym / sponsor ID
- 15-001367
- Conditions
- Transtibial Amputation - Unilateral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Posted 8 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to compare the functional performance of individuals with transtibial amputation using two types of prosthetic foot designs: carbon fiber vs. fiberglass composite.
Detailed description
Recently, a new type of prosthetic foot has appeared on the market. This device is composed of a fiberglass composite material. Knowledge is lacking regarding the performance characteristics of this new device. Comprehensive studies are needed to form a solid basis for prosthetic prescription. The current study sought to understand the experience of community-living, transtibial amputees using this prosthetic foot. Specifically, the biomechanical performance of this device were compared to existing conventional dynamic elastic response (DER) technology in a controlled laboratory setting. The investigators hypothesized that the fiberglass composite material provided more energy return and improved ankle kinematics performance.
The study design was a repeated measures cross-over trial whereby only the prosthetic foot was changed. Each subject was tested using their current carbon-fiber energy storage and return prosthetic foot (CFPF) and the fiberglass composite energy storage and return prosthetic foot (Rush, Ability Dynamics) (FPF). Half of the subjects began the study on the CFPF while the other half began on the FPF. All types of CFPF were used in this study. Each subject was given an acclimation period (about 4 weeks) before testing, which was consistent with other similar studies. The same socket and suspension were used throughout the study in order to eliminate these confounding variables.
A 10 camera, high resolution motion capture system with a set of 51 reflective markers was used to capture whole-body motion. Three-dimensional marker trajectory data was collected at 120 Hz and filtered using a fourth-order Butterworth low-pass filter with a cutoff frequency of 8 Hz. The standard Helen Hayes marker set and some additional markers were applied to the subject. Additional markers included an anterior pylon marker, medial pylon marker, lateral pylon marker, right and left medial calcaneus markers, and right and left lateral calcaneus markers. In addition, left and right medial knee markers were used for establishing the knee joint centers and were then removed for the walking trails. Subjects wore standard laboratory athletic shoes for all walking trials. All of the markers associated with the foot were placed on the outside of the subject's shoes.
Following the application of the reflective marker set, the subject performed tests while walking over level ground at a self-selected and normalized speed as well as up and down a 10 degree inclined ramp. The normalized speed controlled for leg length by normalizing to a Froude (Fr) number of 0.25 where Fr = v^2/gl, and v is the walking speed, g is the gravitational constant, and l is the leg length using the greater trochanter height as leg length. Timing gates were used to control the walking speed. Simultaneously, ground reaction force data was collected from force plates at a sampling rate of 600 Hz. Data from these force plates was time-synchronized with the motion cameras. The ramp had a force plate embedded within the ramp.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This was a repeated measures cross-over trial whereby only the prosthetic foot was changed. Each subject was tested using their current carbon-fiber prosthetic foot (CFPF), and the fiberglass prosthetic foot (FPF). Half of the subjects began the study on the CFPF while the other half began on the FPF. Each subject was given an acclimation period of 4 weeks before testing.
| Arm | Type | Receives |
|---|---|---|
| CFPF first, then FPF | Experimental | Device: Fiberglass Composite foot, Device: Carbon Fiber Composite FootAfter a 4 week acclimation period, subjects were studied on their current carbon fiber composite foot (CFPF), followed by another 4 week acclimation period, then studied on the study provided fiberglass composite foot (FPF). |
| FPF first, then CFPF | Experimental | Device: Fiberglass Composite foot, Device: Carbon Fiber Composite FootAfter a 4 week acclimation period, subjects were studied on the study provided fiberglass composite foot (FPF), followed by another 4 week acclimation period, then studied on their current carbon fiber composite foot (CFPF). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Unilateral transtibial amputee
- Currently using a carbon fiber prosthetic (DER) foot for at least the last 6 months
- Stable stump volume over the past 6 months
- Medicare Functional Classification Level K3 or K4
Key exclusion criteria (4 listed)
- Neuromuscular problems such as previous stroke or contralateral amputation
- Use of gait aids for ambulation
- Undergoing dialysis
- Poor prosthetic socket fit or stump problems (e.g., skin breakdown)
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 |
|---|---|---|
| Fiberglass Composite footAlso: Rush FootThe Rush foot is a fiberglass composite energy storage and return prosthetic foot. | Device | CFPF first, then FPF, FPF first, then CFPF |
| Carbon Fiber Composite FootAlso: Otto Bock Triton, Ossur Variflex, Ossur Variflex EVO, Ossur Reflex ShockAll types of currently commercially available carbon fiber energy storage and return prosthetic feet will be considered appropriate. | Device | CFPF first, then FPF, FPF first, then CFPF |
Primary outcome
Peak Ankle Dorsiflexion During Stance
Time frame: After approximate 4 week acclimation period
The peak ankle dorsiflexion is the peak ankle backward flexion or bending when walking.
5 secondary outcomes
Peak Ankle Plantar Flexor Moment During Stance
Time frame: After approximate 4 week acclimation period
Peak Ankle Power Generation
Time frame: After approximate 4 week acclimation period
Peak Knee Flexion During Swing
Time frame: After approximate 4 week acclimation period
Time of Peak Knee Flexion During Swing
Time frame: After approximate 4 week acclimation period
Patient Satisfaction as Measured by the Prosthesis Evaluation Questionnaire (PEQ)
Time frame: After approximate 4 week acclimation period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33856155Kaufman KR, Bernhardt K. Functional performance differences between carbon fiber and fiberglass prosthetic feet. Prosthet Orthot Int. 2021 Jun 1;45(3):205-213. doi: 10.1097/PXR.0000000000000004.
- Individual participant dataSharing planned: Undecided
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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.
Kenton R Kaufman, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fiberglass Composite foot and Carbon Fiber Composite Foot in people with Transtibial Amputation - Unilateral, run by Mayo Clinic 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 4 inclusion and 4 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 20 Sep 2018. 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?
Yes. Results are posted in the registry (first posted 8 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Peak Ankle Dorsiflexion During Stance (time frame: After approximate 4 week acclimation period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02542761, which also lists 1 linked publication.
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 20 Sep 2018.