Transtibial AmputationNCT02440711
Evaluation of a Modified Running-specific Prosthetic Foot
A study testing Energy storing foot (ESF) and Modified running specific foot (mRSF) in people with Transtibial Amputation, run by University of Washington at 1 site in United States.
Trial summary
The goal of this study is to evaluate endurance, walking performance, mobility, and perceived exertion of transtibial prosthesis users (i.e., study participants) walking with a conventional energy storing prosthetic foot (ESF) and a novel modified running-specific prosthesis (mRSF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transtibial Amputation
- What is being tested?
- Energy storing foot (ESF) and Modified running specific foot (mRSF)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Mar 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral or bilateral, transtibial (below-knee) amputation from non-dysvascular causes
- Medicare functional classification level (K-level) 3 or higher (unlimited community ambulatory)
- prosthetic user for > 1 year
- scheduled to receive a mRSF prosthesis
- able and willing to participate in the study protocol (e.g., treadmill walking, overground walking, respond to survey questions, able to read and write English)
Who cannot join
- contralateral lower or upper limb involvement
- any health condition that would limit participation in the study procedures (e.g., skin breakdown, heart disease)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endurance, Energy Expenditure, Perceived Function, and Satisfaction of Persons With Transtibial Limb Loss Using a Running-Specific Prosthesis Modified for Walking
The goal of this study is to evaluate endurance, walking performance, mobility, and perceived exertion of transtibial prosthesis users (i.e., study participants) walking with a conventional energy storing prosthetic foot (ESF) and a novel modified running-specific prosthesis (mRSF). A randomized cross-over study will be conducted to determine if the mRSF provides superior performance to the ESF, which is commonly prescribed to most active individuals with lower limb amputation.
Read the detailed description
Amputation of a limb is a life-altering event with profound physical, psychological, and social implications. To address their functional, vocational, and recreational needs, people with lower limb amputation (LLA) are often provided with a prosthesis or artificial leg. While use of a prosthesis can allow an individual to achieve a basic level of functional mobility, absence of an anatomical foot and ankle still impairs their physical performance. As a result, people with LLA regularly exhibit decreased walking speeds, diminished endurance, and restricted ability to participate in desired life situations.
Over the past three decades, increasingly sophisticated prosthetic foot designs have been developed by the prosthetics industry to replace amputated structures in the leg. Contemporary, energy storing feet (ESF) employ advanced materials and unique geometric designs to improve walking performance and endurance of their users. Although prosthetic limbs with ESF allow people with LLA the potential to return to an active lifestyle, even the most advanced ESF do not significantly reduce the increased energy demands required for walking when compared to conventional prosthetic feet.
Commercially-available running-specific feet (RSF) like the Össur Cheetah (Össur, Reykjavik, Iceland) allow people with LLA to participate in athletic activities and sporting events. RSF provide significantly enhanced performance, compared to traditional ESF, by extending the length and increasing the stiffness of the prosthetic keel (forefoot). RSF also do not include a heel, as they are used only for running activities. Although transtibial runners with RSF exhibit endurance levels similar to non-amputees, the RSF design does not allow the biomechanical movements or provide the stability needed to use the foot for walking (over level or uneven terrain).
A novel modified running-specific foot (mRSF) has been developed to integrate the performance of a RSF with the utility of an ESF. The mRSF combines the running keel (forefoot) of a RSF with the walking heel of a ESF. The mRSF can then be used for walking, running, and other routine daily activities. Preliminary feedback on the mRSF suggests that users experience improved overall function and high satisfaction with the device. However, empirical evidence is needed to support prescription of this prosthetic foot at other clinical facilities.
The goal of this study is therefore to evaluate endurance, walking performance, mobility, and perceived exertion of transtibial prosthesis users (i.e., study participants) walking with a conventional ESF and the mRSF. Results will be compared to determine if the mRSF provides superior performance to the ESF, which is commonly prescribed to most active individuals with LLA.
- Conditions
- Transtibial Amputation
- Being tested
- Energy storing foot (ESF), Modified running specific foot (mRSF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy storing foot (ESF)Device
Also called Ossur Vari-flex
A commercially-available energy storing prosthetic foot
Modified running specific foot (mRSF)Device
Also called Ossur Cheetah (modified); Ossur Xplore
A running specific prosthetic foot customized for both running and walking activities
| Study group | Role | What they receive |
|---|---|---|
| mRSF-ESF | Experimental | Study participants in Arm 1 will first receive the Modified running specific foot (mRSF) and then the Energy storing foot (ESF). Outcomes will be assessed (in each condition) after 1 month of use. Order of interventions will be randomly assigned. Receives: Device: Energy storing foot (ESF); Device: Modified running specific foot (mRSF) |
| ESF-mRSF | Experimental | Study participants in Arm 2 will first receive the Energy storing foot (ESF) and then the Modified running specific foot (mRSF). Outcomes will be assessed (in each condition) after 1 month of use. Order of interventions will be randomly assigned. Receives: Device: Energy storing foot (ESF); Device: Modified running specific foot (mRSF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Oxygen Consumption (VO2), Participants With Unilateral Amputation
Breath-by-Breath VO2 was collected as participants walked on a treadmill at self selected fast, normal, and slow speeds. Participants walked for 6 minutes at each speed (and in each experimental condition). VO2 was normalized energy expenditure to each participant's biological mass (i.e., body mass without prosthesis) Normalized VO2 data were averaged to produce 30-s values for minutes 3-6 of each trial. These 30-s values were used in for the described analyses. Both gross and net VO2 were examined, but produced similar results, so only gross VO2 results are reported.
Measured: Participants were tested after using each foot in their prosthesis for 1 month.
Metabolic Oxygen Consumption (VO2), Participants With Bilateral Amputation
Breath-by-Breath VO2 was collected as participants walked on a treadmill at self selected fast, normal, and slow speeds. Participants walked for 6 minutes at each speed (and in each experimental condition). VO2 was normalized energy expenditure to each participant's biological mass (i.e., body mass without prosthesis) Normalized VO2 data were averaged to produce 30-s values for minutes 3-6 of each trial. These 30-s values were used in for the described analyses. Both gross and net VO2 were examined, but produced similar results, so only gross VO2 results are reported.
Measured: Participants were tested after using each foot in their prosthesis for 1 month.
Six-minute Walk Test (6MWT), Participants With Unilateral Amputation
Participants were asked to walk as far as possible in 6 minutes. Participants walked around cones placed 30m apart in a level hallway. Total distance (in meters) walked in 6 minutes was recorded.
Measured: Participants were tested after using each foot in their prosthesis for 1 month.
Six-minute Walk Test (6MWT), Participants With Bilateral Amputation
Participants were asked to walk as far as possible in 6 minutes. Participants walked around cones placed 30m apart in a level hallway. Total distance (in meters) walked in 6 minutes was recorded.
Measured: Participants were tested after using each foot in their prosthesis for 1 month.
Borg Rating of Perceived Exertion (CR100), Participants With Unilateral Amputation
Participants were asked to self-report their level of perceived exertion after completing the 6MWT. Participants were shown the Borg CR100 rating scale and asked to identify their level of exertion on a scale ranging from 0 to 120. Higher scores mean greater exertion.
Measured: Participants were tested after using each foot in their prosthesis for 1 month.
Borg Rating of Perceived Exertion (CR100), Participants With Bilateral Amputation
Participants were asked to self-report their level of perceived exertion after completing the 6MWT. Participants were shown the Borg CR100 rating scale and asked to identify their level of exertion on a scale ranging from 0 to 120. Higher scores mean greater exertion.
Measured: Participants were tested after using each foot in their prosthesis for 1 month.
Walking Speed, Participants With Unilateral Amputation
Walking speed (m/s) was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT).
Measured: Participants were tested after using each foot in their prosthesis for 1 month.
Walking Speed, Participants With Bilateral Amputation
Walking speed (m/s) was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT).
Measured: Participants were tested after using each foot in their prosthesis for 1 month.
Step Width, Participants With Unilateral Amputation
Step width was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT).
Measured: Participants were tested after using each foot in their prosthesis for 1 month.
Step Width, Participants With Bilateral Amputation
Step width was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT).
Measured: Participants were tested after using each foot in their prosthesis for 1 month.
Step Length, Participants With Unilateral Amputation
Step length (cm) was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT). Step length is reported for both the prosthetic and sound (intact) limbs.
Measured: Participants were tested after using each foot in their prosthesis for 1 month.
Step Length, Participants With Bilateral Amputation
Step length (cm) was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT). Step length is reported for both the prosthetic and sound (intact) limbs.
Measured: Participants were tested after using each foot in their prosthesis for 1 month.
Step Time, Participants With Unilateral Amputation
Step time was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT). Step time is reported for both the prosthetic and sound (intact) limbs.
Measured: Participants were tested after using each foot in their prosthesis for 1 month.
Step Time, Participants With Bilateral Amputation
Step time was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT). Step time is reported for both the prosthetic and sound (intact) limbs.
Measured: Participants were tested after using each foot in their prosthesis for 1 month.
Secondary outcomes (10)
Daily Step Activity, Participants With Unilateral Amputation
Daily step activity (steps / day) were measured over the 2-week period prior to assessment using a Orthocare Innovations Stepwatch 3 activity monitor.
Measured: Participants' step count data from the 2 weeks prior to in-person testing.
Daily Step Activity, Participants With Bilateral Amputation
Daily step activity (steps / day) were measured over the 2-week period prior to assessment using a Orthocare Innovations Stepwatch 3 activity monitor.
Measured: Participants' step count data from the 2 weeks prior to in-person testing.
Prosthetic Limb Users Survey of Mobility (PLUS-M), Participants With Unilateral Amputation
The PLUS-M is a self-report instrument designed to evaluate respondent's prosthetic mobility. It is scored using a standardized T-score centered on a national sample of unilateral lower limb prosthesis users (mean = 50, standard deviation = 10). Participants were administered the PLUS-M computerized adaptive test and 12-item form on an iPad tablet. The most precise score (i.e., score with the lowest error) was used for analysis. Absolute score range from 0 to 100. Higher T-scores indicate greater mobility.
Measured: Participants were tested after using each foot in their prosthesis for 1 month.
Prosthetic Limb Users Survey of Mobility (PLUS-M), Participants With Bilateral Amputation
The PLUS-M is a self-report instrument designed to evaluate respondent's prosthetic mobility. It is scored using a standardized T-score centered on a national sample of unilateral lower limb prosthesis users (mean = 50, standard deviation = 10). Participants were administered the PLUS-M computerized adaptive test and 12-item form on an iPad tablet. The most precise score (i.e., score with the lowest error) was used for analysis. Absolute score range from 0 to 100. Higher T-scores indicate greater mobility.
Measured: Participants were tested after using each foot in their prosthesis for 1 month.
Patient Reported Outcome Measurement Information System - Fatigue (PROMIS-Fatigue), Participants With Unilateral Amputation
The PROMIS-Fatigue is a self-report instrument designed to evaluate respondent's symptoms and effects of fatigue. It is scored using a standardized T-score centered on the US general population (mean = 50, standard deviation = 10). Participants were administered the computerized adaptive test and a 12-item short form on an iPad tablet. The most precise score (i.e., score with the lowest error) was used for analysis. Absolute score range from 0 to 100. Higher T-scores indicate greater fatigue.
Measured: Participants were tested after using each foot in their prosthesis for 1 month.
Patient Reported Outcome Measurement Information System - Fatigue (PROMIS-Fatigue), Participants With Bilateral Amputation
The PROMIS-Fatigue is a self-report instrument designed to evaluate respondent's symptoms and effects of fatigue. It is scored using a standardized T-score centered on the US general population (mean = 50, standard deviation = 10). Participants were administered the computerized adaptive test and a 12-item short form on an iPad tablet. The most precise score (i.e., score with the lowest error) was used for analysis. Absolute score range from 0 to 100. Higher T-scores indicate greater fatigue.
Measured: Participants were tested after using each foot in their prosthesis for 1 month.
Activities-Specific Balance Confidence Scale (ABC), Participants With Unilateral Amputation
The ABC is a self-report instrument designed to evaluate respondent's confidence in performing normal daily activities. It is scored from 0 to 4. Participants were administered an electronic version of the ABC on an iPad tablet. Scores range from 0 to 4. Higher scores indicate greater balance confidence.
Measured: Participants were tested after using each foot in their prosthesis for 1 month.
Activities-Specific Balance Confidence Scale (ABC), Participants With Bilateral Amputation
The ABC is a self-report instrument designed to evaluate respondent's confidence in performing normal daily activities. It is scored from 0 to 4. Participants were administered an electronic version of the ABC on an iPad tablet. Scores range from 0 to 4. Higher scores indicate greater balance confidence.
Measured: Participants were tested after using each foot in their prosthesis for 1 month.
Trinity Amputation Prosthesis Experience Scales, Revised (TAPES-R), Participants With Unilateral Amputation
The TAPES-R is a self-report instrument designed to evaluate respondent's activity restrictions and satisfaction with a prosthesis. The TAPES-R has three subscales (activity restrictions [TAPES-AR], functional satisfaction [TAPES-FUN], and aesthetic satisfaction [TAPES-AES], each scored from 0 to 2. Higher scores indicate more activity restrictions (TAPES-AR) or greater satisfaction (TAPES-FUN and TAPES-AES). Participants were administered an electronic version of the TAPES-R on an iPad tablet.
Measured: Participants were tested after using each foot in their prosthesis for 1 month.
Trinity Amputation Prosthesis Experience Scales, Revised (TAPES-R), Participants With Bilateral Amputation
The TAPES-R is a self-report instrument designed to evaluate respondent's activity restrictions and satisfaction with a prosthesis. The TAPES-R has three subscales (activity restrictions [TAPES-AR], functional satisfaction [TAPES-FUN], and aesthetic satisfaction [TAPES-AES], each scored from 0 to 2. Higher scores indicate more activity restrictions (TAPES-AR) or greater satisfaction (TAPES-FUN and TAPES-AES). Participants were administered an electronic version of the TAPES-R on an iPad tablet.
Measured: Participants were tested after using each foot in their prosthesis for 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startMay 2015
- Primary completionMar 2018
- Study completionMar 2018
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 AmputationStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Hafner, University of Washington
- Investigators
- Brian Hafner, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440711
- Sponsor's protocol ID
- 49150
- Status last verified
- Jul 2023
- First submitted
- 7 May 2015
- Last updated
- 2 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Morgan SJ, McDonald CL, Halsne EG, Cheever SM, Salem R, Kramer PA, Hafner BJ. Laboratory- and community-based health outcomes in people with transtibial amputation using crossover and energy-storing prosthetic feet: A randomized crossover trial. PLoS One. 2018 Feb 7;13(2):e0189652. doi: 10.1371/journal.pone.0189652. eCollection 2018.
PubMed 29414988
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endurance, Energy Expenditure, Perceived Function, and Satisfaction of Persons With Transtibial Limb Loss Using a Running-Specific Prosthesis Modified for Walking
- ClinicalTrials.gov ID
- NCT02440711
- Acronym / sponsor ID
- 49150
- Conditions
- Transtibial Amputation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Posted 2 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate endurance, walking performance, mobility, and perceived exertion of transtibial prosthesis users (i.e., study participants) walking with a conventional energy storing prosthetic foot (ESF) and a novel modified running-specific prosthesis (mRSF). A randomized cross-over study will be conducted to determine if the mRSF provides superior performance to the ESF, which is commonly prescribed to most active individuals with lower limb amputation.
Detailed description
Amputation of a limb is a life-altering event with profound physical, psychological, and social implications. To address their functional, vocational, and recreational needs, people with lower limb amputation (LLA) are often provided with a prosthesis or artificial leg. While use of a prosthesis can allow an individual to achieve a basic level of functional mobility, absence of an anatomical foot and ankle still impairs their physical performance. As a result, people with LLA regularly exhibit decreased walking speeds, diminished endurance, and restricted ability to participate in desired life situations.
Over the past three decades, increasingly sophisticated prosthetic foot designs have been developed by the prosthetics industry to replace amputated structures in the leg. Contemporary, energy storing feet (ESF) employ advanced materials and unique geometric designs to improve walking performance and endurance of their users. Although prosthetic limbs with ESF allow people with LLA the potential to return to an active lifestyle, even the most advanced ESF do not significantly reduce the increased energy demands required for walking when compared to conventional prosthetic feet.
Commercially-available running-specific feet (RSF) like the Össur Cheetah (Össur, Reykjavik, Iceland) allow people with LLA to participate in athletic activities and sporting events. RSF provide significantly enhanced performance, compared to traditional ESF, by extending the length and increasing the stiffness of the prosthetic keel (forefoot). RSF also do not include a heel, as they are used only for running activities. Although transtibial runners with RSF exhibit endurance levels similar to non-amputees, the RSF design does not allow the biomechanical movements or provide the stability needed to use the foot for walking (over level or uneven terrain).
A novel modified running-specific foot (mRSF) has been developed to integrate the performance of a RSF with the utility of an ESF. The mRSF combines the running keel (forefoot) of a RSF with the walking heel of a ESF. The mRSF can then be used for walking, running, and other routine daily activities. Preliminary feedback on the mRSF suggests that users experience improved overall function and high satisfaction with the device. However, empirical evidence is needed to support prescription of this prosthetic foot at other clinical facilities.
The goal of this study is therefore to evaluate endurance, walking performance, mobility, and perceived exertion of transtibial prosthesis users (i.e., study participants) walking with a conventional ESF and the mRSF. Results will be compared to determine if the mRSF provides superior performance to the ESF, which is commonly prescribed to most active individuals with LLA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mRSF-ESF | Experimental | Device: Energy storing foot (ESF), Device: Modified running specific foot (mRSF)Study participants in Arm 1 will first receive the Modified running specific foot (mRSF) and then the Energy storing foot (ESF). Outcomes will be assessed (in each condition) after 1 month of use. Order of interventions will be randomly assigned. |
| ESF-mRSF | Experimental | Device: Energy storing foot (ESF), Device: Modified running specific foot (mRSF)Study participants in Arm 2 will first receive the Energy storing foot (ESF) and then the Modified running specific foot (mRSF). Outcomes will be assessed (in each condition) after 1 month of use. Order of interventions will be randomly assigned. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- unilateral or bilateral, transtibial (below-knee) amputation from non-dysvascular causes
- Medicare functional classification level (K-level) 3 or higher (unlimited community ambulatory)
- prosthetic user for > 1 year
- scheduled to receive a mRSF prosthesis
- able and willing to participate in the study protocol (e.g., treadmill walking, overground walking, respond to survey questions, able to read and write English)
Key exclusion criteria (2 listed)
- contralateral lower or upper limb involvement
- any health condition that would limit participation in the study procedures (e.g., skin breakdown, heart disease)
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 |
|---|---|---|
| Energy storing foot (ESF)Also: Ossur Vari-flexA commercially-available energy storing prosthetic foot | Device | ESF-mRSF, mRSF-ESF |
| Modified running specific foot (mRSF)Also: Ossur Cheetah (modified); Ossur XploreA running specific prosthetic foot customized for both running and walking activities | Device | ESF-mRSF, mRSF-ESF |
Primary outcome
Metabolic Oxygen Consumption (VO2), Participants With Unilateral Amputation
Time frame: Participants were tested after using each foot in their prosthesis for 1 month.
Breath-by-Breath VO2 was collected as participants walked on a treadmill at self selected fast, normal, and slow speeds. Participants walked for 6 minutes at each speed (and in each experimental condition). VO2 was normalized energy expenditure to each participant's biological mass (i.e., body mass without prosthesis) Normalized VO2 data were averaged to produce 30-s values for minutes 3-6 of each trial. These 30-s values were used in for the described analyses. Both gross and net VO2 were examined, but produced similar results, so only gross VO2 results are reported.
Metabolic Oxygen Consumption (VO2), Participants With Bilateral Amputation
Time frame: Participants were tested after using each foot in their prosthesis for 1 month.
Breath-by-Breath VO2 was collected as participants walked on a treadmill at self selected fast, normal, and slow speeds. Participants walked for 6 minutes at each speed (and in each experimental condition). VO2 was normalized energy expenditure to each participant's biological mass (i.e., body mass without prosthesis) Normalized VO2 data were averaged to produce 30-s values for minutes 3-6 of each trial. These 30-s values were used in for the described analyses. Both gross and net VO2 were examined, but produced similar results, so only gross VO2 results are reported.
Six-minute Walk Test (6MWT), Participants With Unilateral Amputation
Time frame: Participants were tested after using each foot in their prosthesis for 1 month.
Participants were asked to walk as far as possible in 6 minutes. Participants walked around cones placed 30m apart in a level hallway. Total distance (in meters) walked in 6 minutes was recorded.
Six-minute Walk Test (6MWT), Participants With Bilateral Amputation
Time frame: Participants were tested after using each foot in their prosthesis for 1 month.
Participants were asked to walk as far as possible in 6 minutes. Participants walked around cones placed 30m apart in a level hallway. Total distance (in meters) walked in 6 minutes was recorded.
Borg Rating of Perceived Exertion (CR100), Participants With Unilateral Amputation
Time frame: Participants were tested after using each foot in their prosthesis for 1 month.
Participants were asked to self-report their level of perceived exertion after completing the 6MWT. Participants were shown the Borg CR100 rating scale and asked to identify their level of exertion on a scale ranging from 0 to 120. Higher scores mean greater exertion.
Borg Rating of Perceived Exertion (CR100), Participants With Bilateral Amputation
Time frame: Participants were tested after using each foot in their prosthesis for 1 month.
Participants were asked to self-report their level of perceived exertion after completing the 6MWT. Participants were shown the Borg CR100 rating scale and asked to identify their level of exertion on a scale ranging from 0 to 120. Higher scores mean greater exertion.
Walking Speed, Participants With Unilateral Amputation
Time frame: Participants were tested after using each foot in their prosthesis for 1 month.
Walking speed (m/s) was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT).
Walking Speed, Participants With Bilateral Amputation
Time frame: Participants were tested after using each foot in their prosthesis for 1 month.
Walking speed (m/s) was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT).
Step Width, Participants With Unilateral Amputation
Time frame: Participants were tested after using each foot in their prosthesis for 1 month.
Step width was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT).
Step Width, Participants With Bilateral Amputation
Time frame: Participants were tested after using each foot in their prosthesis for 1 month.
Step width was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT).
Step Length, Participants With Unilateral Amputation
Time frame: Participants were tested after using each foot in their prosthesis for 1 month.
Step length (cm) was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT). Step length is reported for both the prosthetic and sound (intact) limbs.
Step Length, Participants With Bilateral Amputation
Time frame: Participants were tested after using each foot in their prosthesis for 1 month.
Step length (cm) was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT). Step length is reported for both the prosthetic and sound (intact) limbs.
Step Time, Participants With Unilateral Amputation
Time frame: Participants were tested after using each foot in their prosthesis for 1 month.
Step time was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT). Step time is reported for both the prosthetic and sound (intact) limbs.
Step Time, Participants With Bilateral Amputation
Time frame: Participants were tested after using each foot in their prosthesis for 1 month.
Step time was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT). Step time is reported for both the prosthetic and sound (intact) limbs.
10 secondary outcomes
Daily Step Activity, Participants With Unilateral Amputation
Time frame: Participants' step count data from the 2 weeks prior to in-person testing.
Daily Step Activity, Participants With Bilateral Amputation
Time frame: Participants' step count data from the 2 weeks prior to in-person testing.
Prosthetic Limb Users Survey of Mobility (PLUS-M), Participants With Unilateral Amputation
Time frame: Participants were tested after using each foot in their prosthesis for 1 month.
Prosthetic Limb Users Survey of Mobility (PLUS-M), Participants With Bilateral Amputation
Time frame: Participants were tested after using each foot in their prosthesis for 1 month.
Patient Reported Outcome Measurement Information System - Fatigue (PROMIS-Fatigue), Participants With Unilateral Amputation
Time frame: Participants were tested after using each foot in their prosthesis for 1 month.
Patient Reported Outcome Measurement Information System - Fatigue (PROMIS-Fatigue), Participants With Bilateral Amputation
Time frame: Participants were tested after using each foot in their prosthesis for 1 month.
Activities-Specific Balance Confidence Scale (ABC), Participants With Unilateral Amputation
Time frame: Participants were tested after using each foot in their prosthesis for 1 month.
Activities-Specific Balance Confidence Scale (ABC), Participants With Bilateral Amputation
Time frame: Participants were tested after using each foot in their prosthesis for 1 month.
Trinity Amputation Prosthesis Experience Scales, Revised (TAPES-R), Participants With Unilateral Amputation
Time frame: Participants were tested after using each foot in their prosthesis for 1 month.
Trinity Amputation Prosthesis Experience Scales, Revised (TAPES-R), Participants With Bilateral Amputation
Time frame: Participants were tested after using each foot in their prosthesis for 1 month.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29414988Morgan SJ, McDonald CL, Halsne EG, Cheever SM, Salem R, Kramer PA, Hafner BJ. Laboratory- and community-based health outcomes in people with transtibial amputation using crossover and energy-storing prosthetic feet: A randomized crossover trial. PLoS One. 2018 Feb 7;13(2):e0189652. doi: 10.1371/journal.pone.0189652. eCollection 2018.
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Transtibial Amputation, Lower Limb Amputation
RecruitingPhase 1
Influence of Prosthetic Foot Stiffness on Transtibial Osseointegrated Bone-Anchored Limb Outcomes
Amputation, Transtibial Amputation - Unilateral
Recruiting
Transtibial Osseointegration
Amputation; Traumatic, Leg, Lower
Active, not recruitingEarly Phase 1
Feasibility Study Evaluating the Safety and Effectiveness of Magnetic Bead Tracking System When Used With a Bionic External Prosthesis
Transtibial Amputee, Transtibial Amputation
Recruiting
Reliability and Validity of Continuous Inter-limb Stability
Amputation, Lower Limb
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.
Brian Hafner, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Energy storing foot (ESF) and Modified running specific foot (mRSF) in people with Transtibial Amputation, run by University of Washington 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 5 inclusion and 2 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 2 Aug 2023. 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 2 Aug 2023). 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?
Metabolic Oxygen Consumption (VO2), Participants With Unilateral Amputation (time frame: Participants were tested after using each foot in their prosthesis for 1 month.). The study lists 14 primary outcomes in all. 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 NCT02440711, 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 2 Aug 2023.