AmputationBestBikeFitNCT03828331
Optimizing Prosthetic and Bicycle Fit for Veterans With Transtibial Amputations
An observational study of Amputation, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Bicycling is a promising form of low-impact exercise that could prevent/treat Type 2 diabetes. However, Veterans with transtibial amputations (TTAs) may not effectively utilize bicycling for rehabilitation and exercise due to improper bike fit, socket discomfort, and/or the potential for injury. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation
- What is being tested?
- Prosthetic/Bicycle Configuration
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 31 Aug 2023
- Phase
- Observational
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The investigators will recruit 15 subjects with unilateral transtibial amputations from the VA Jewell Clinic, locally, and nationally.
Who may be able to join
- One amputation below the knee
- At least 1 year of experience using a prosthesis
- No current problems with the prosthesis or residual limb
- At or above a K3 Medicare Functional Classification Level
Who cannot join
- Poor general health
- Difficulty with mobility
- Problems with balance or dizziness
- Current serious musculoskeletal injury besides that associated with an amputation
- Cardiovascular, pulmonary, or neurological disease or disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045
About this study
Bicycling is a promising form of low-impact exercise that could prevent/treat Type 2 diabetes. However, Veterans with transtibial amputations (TTAs) may not effectively utilize bicycling for rehabilitation and exercise due to improper bike fit, socket discomfort, and/or the potential for injury. An optimized prosthetic/bicycle fit could improve comfort and reduce injury risk by decreasing asymmetries between legs, lowering metabolic costs, and improving efficiency for Veterans with TTAs during bicycling. Moreover, the use of objective prosthetic/bicycle fit guidelines would allow clinicians to facilitate shorter appointment times and fewer revisits for Veterans with TTAs. The investigators will determine the physiological and biomechanical effects of different prosthetic and bicycle configurations for Veterans with a TTA to develop optimal prosthetic/bicycle fit guidelines. The investigators hypothesize that a longer prosthetic pylon length and shorter bicycle crank arm length for the affected compared to the unaffected leg along with a pedal attachment position beneath the pylon compared to beneath the forefoot will optimize performance for Veterans with TTAs the investigators' research will integrate evidence-based guidelines to advance rehabilitation and enhance the lives of Veterans with an amputation, thus improving and restoring their function.
Read the detailed description
Over one million people in the United States have a leg amputation and this number continues to grow due to the prevalence of diabetes and recent military conflicts. Because of the functional impairment caused by an amputation, it is extremely important to advance rehabilitation that optimizes the use of prostheses so that Veterans with amputations can regain the greatest possible level of health, function, and physical activity. Low-impact exercise such as bicycling could facilitate return to work/duty after amputation by improving cardiovascular fitness, muscle strength, endurance, and quality of life for Veterans with transtibial amputations (TTAs). Bicycling as exercise could also prevent the deleterious effects of vascular disease and diabetes by improving cardiovascular function, controlling body weight, decreasing the rate of re-amputation, and improving quality of life for Veterans with TTAs. However, it is likely that discomfort and the increased potential for secondary musculoskeletal injury due to the lack of a proper prosthetic/bike fit discourages Veterans with TTAs from using bicycling for rehabilitation and exercise. Moreover, it is unclear how prosthetic and bicycle components, such as pylon length (PL), pedal attachment position (PAP) beneath the prosthetic forefoot versus the pylon, and crank arm length (CAL) affect the biomechanics, metabolic costs, and comfort/ satisfaction of Veterans with TTAs. Thus, the investigators' goal is to challenge the state-of-the-science by developing evidence-based prosthetic and bicycle fit guidelines that optimize the biomechanics, metabolic costs, efficiency (mechanical power/metabolic power) and comfort/satisfaction for Veterans with TTAs. The Department of Veterans Affairs (VA) and Department of Defense (DoD) Rehabilitation Directive has put forth an initiative that aims to dramatically improve and restore function in wounded Veterans and Service members so that they have the choice to return to active duty or productive civilian employment. The proposed research will establish optimal prosthetic/bicycle fit guidelines, which would enhance function by improving cardiovascular health, controlling body weight, decreasing re-amputation rates, and enhancing quality of life of Veterans with TTAs, thus helping to fulfill this initiative and having high potential impact. Specifically, the investigators aim to: 1) Study 15 Veterans with unilateral TTAs to determine the effects of systematically varying PL, PAP beneath the prosthetic forefoot versus the pylon, and CAL for the affected leg on bicycling biomechanics, metabolic costs, and comfort/satisfaction. 2) Synthesize and disseminate the investigators' findings into practical, evidence-based quantitative prosthetic/bicycle fit guidelines for Veterans with TTAs. The investigators hypothesize that a longer PL and shorter CAL for the affected compared to the unaffected leg along with a PAP beneath the pylon compared to beneath the forefoot will maximize mechanical power symmetry and reduce metabolic cost and muscle activity, and thus maximize efficiency and comfort/satisfaction during bicycling in Veterans with unilateral TTAs. The utilization of evidence-based prosthetic/bicycle fit guidelines that increase symmetry, improve comfort, reduce the risk of injury, decrease metabolic costs, and improve efficiency will directly benefit Veterans with TTAs by increasing their physical activity and function. Optimized prosthetic/bicycle fit guidelines will allow Veterans TTAs who were previously unable to comfortably ride a bicycle, as well as those currently riding a bicycle, to ride longer with less effort and discomfort, potentially leading to an improved quality of life. Moreover, the prosthetic/bicycle fit guidelines generated by this research will ensure that clinicians are able to fit Veterans with TTAs to bicycles more effectively, leading to shorter appointment times and fewer revisits due to enhanced function and reduced comorbidities.
- Conditions
- Amputation
- Being tested
- Prosthetic/Bicycle Configuration
- Keywords
- Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosthetic/Bicycle ConfigurationOther
The investigators will measure the biomechanics (motion, forces, and muscle activity) and metabolic rates while subjects ride using an initial bike fit and three taller pylon lengths (PL) for the affected leg (AL) in increments of 6.8 mm using a pedal attachment position (PAP) beneath the prosthetic forefoot. Then, using the optimal (most efficient) PL, the investigators will measure the biomechanics and metabolic rates while subjects ride using three shorter crank arm lengths (CALs) for the AL in decrements of 6.8 mm using a PAP beneath the prosthetic forefoot. On Day 2, the investigators will repeat the protocol of Day 1, but have riders use a PAP beneath the pylon for their AL.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Transtibial Amputation | The investigators will recruit participants with unilateral transtibial amputations who are at or above a K3 Medicare functional classification level (MFCL), and 18-55 years old. A K3 MFCL means that a person has the ability or potential for ambulation with variable cadence. A person at K3 MFCL is a typical community ambulator who has the ability to traverse most environmental barriers and may have vocational, therapeutic or exercise activity that demands prosthetic use beyond simple locomotion. Receives: Other: Prosthetic/Bicycle Configuration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical Crank Power Output
The investigators calculated crank power output (W/kg) from the product of pedal torque and velocity and normalized this to participant body mass while participants rode at 1.5 W/kg using different prosthetic and bicycle configurations (pylon length, crank arm length, and pedal attachment position).
Measured: Data were collected over 2 days per subject
Net Metabolic Power
The investigators measured net metabolic power (W/kg) using an equation that considers rates of oxygen consumption and carbon dioxide production and normalized this to participant body mass while participants rode at 1.5 W/kg using different prosthetic and bicycle configurations (pylon length, crank arm length, and pedal attachment position).
Measured: Data were collected over 2 days per subject
Perceived Comfort (Visual Analog Scale (VAS))
The investigators measured comfort with a questionnaire that has a range of 0-10 that indicates terrible to excellent, respectively, after participants rode at 1.5 W/kg using different prosthetic and bicycle configurations (pylon length, crank arm length, and pedal attachment position).
Measured: Data were collected over 2 days per subject
Perceived Satisfaction (Prosthesis Evaluation Questionnaire (PEQ))
The investigators measured satisfaction with a questionnaire that has a range of 0-10 that indicates extremely dissatisfied to extremely satisfied, respectively, after participants rode at 1.5 W/kg using different prosthetic and bicycle configurations (pylon length, crank arm length, and pedal attachment position).
Measured: Data were collected over 2 days per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start1 Apr 2019
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
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 AmputationStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Alena Grabowski, PhD BA, Principal investigator, Rocky Mountain Regional VA Medical Center, Aurora, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828331
- Sponsor's protocol ID
- A3010-P
- Acronym
- BestBikeFit
- Status last verified
- Dec 2024
- First submitted
- 22 Jan 2019
- Last updated
- 10 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Allen SP, Diaz GB, Grabowski AM. The Effect of Unequal Crank Arm Lengths and Cycling-Specific Prostheses for Recreational Riders with a Transtibial Amputation. Med Sci Sports Exerc. 2024 Oct 1;56(10):1976-1987. doi: 10.1249/MSS.0000000000003480. Epub 2024 May 15.
PubMed 38768009
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Prosthetic and Bicycle Fit for Veterans With Transtibial Amputations
- ClinicalTrials.gov ID
- NCT03828331
- Acronym / sponsor ID
- BestBikeFit / A3010-P
- Conditions
- Amputation
- Keywords
- Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 4 Feb 2019 (actual)
- Results
- Posted 10 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bicycling is a promising form of low-impact exercise that could prevent/treat Type 2 diabetes. However, Veterans with transtibial amputations (TTAs) may not effectively utilize bicycling for rehabilitation and exercise due to improper bike fit, socket discomfort, and/or the potential for injury. An optimized prosthetic/bicycle fit could improve comfort and reduce injury risk by decreasing asymmetries between legs, lowering metabolic costs, and improving efficiency for Veterans with TTAs during bicycling. Moreover, the use of objective prosthetic/bicycle fit guidelines would allow clinicians to facilitate shorter appointment times and fewer revisits for Veterans with TTAs. The investigators will determine the physiological and biomechanical effects of different prosthetic and bicycle configurations for Veterans with a TTA to develop optimal prosthetic/bicycle fit guidelines. The investigators hypothesize that a longer prosthetic pylon length and shorter bicycle crank arm length for the affected compared to the unaffected leg along with a pedal attachment position beneath the pylon compared to beneath the forefoot will optimize performance for Veterans with TTAs the investigators' research will integrate evidence-based guidelines to advance rehabilitation and enhance the lives of Veterans with an amputation, thus improving and restoring their function.
Detailed description
Over one million people in the United States have a leg amputation and this number continues to grow due to the prevalence of diabetes and recent military conflicts. Because of the functional impairment caused by an amputation, it is extremely important to advance rehabilitation that optimizes the use of prostheses so that Veterans with amputations can regain the greatest possible level of health, function, and physical activity. Low-impact exercise such as bicycling could facilitate return to work/duty after amputation by improving cardiovascular fitness, muscle strength, endurance, and quality of life for Veterans with transtibial amputations (TTAs). Bicycling as exercise could also prevent the deleterious effects of vascular disease and diabetes by improving cardiovascular function, controlling body weight, decreasing the rate of re-amputation, and improving quality of life for Veterans with TTAs. However, it is likely that discomfort and the increased potential for secondary musculoskeletal injury due to the lack of a proper prosthetic/bike fit discourages Veterans with TTAs from using bicycling for rehabilitation and exercise. Moreover, it is unclear how prosthetic and bicycle components, such as pylon length (PL), pedal attachment position (PAP) beneath the prosthetic forefoot versus the pylon, and crank arm length (CAL) affect the biomechanics, metabolic costs, and comfort/ satisfaction of Veterans with TTAs. Thus, the investigators' goal is to challenge the state-of-the-science by developing evidence-based prosthetic and bicycle fit guidelines that optimize the biomechanics, metabolic costs, efficiency (mechanical power/metabolic power) and comfort/satisfaction for Veterans with TTAs. The Department of Veterans Affairs (VA) and Department of Defense (DoD) Rehabilitation Directive has put forth an initiative that aims to dramatically improve and restore function in wounded Veterans and Service members so that they have the choice to return to active duty or productive civilian employment. The proposed research will establish optimal prosthetic/bicycle fit guidelines, which would enhance function by improving cardiovascular health, controlling body weight, decreasing re-amputation rates, and enhancing quality of life of Veterans with TTAs, thus helping to fulfill this initiative and having high potential impact. Specifically, the investigators aim to: 1) Study 15 Veterans with unilateral TTAs to determine the effects of systematically varying PL, PAP beneath the prosthetic forefoot versus the pylon, and CAL for the affected leg on bicycling biomechanics, metabolic costs, and comfort/satisfaction. 2) Synthesize and disseminate the investigators' findings into practical, evidence-based quantitative prosthetic/bicycle fit guidelines for Veterans with TTAs. The investigators hypothesize that a longer PL and shorter CAL for the affected compared to the unaffected leg along with a PAP beneath the pylon compared to beneath the forefoot will maximize mechanical power symmetry and reduce metabolic cost and muscle activity, and thus maximize efficiency and comfort/satisfaction during bicycling in Veterans with unilateral TTAs. The utilization of evidence-based prosthetic/bicycle fit guidelines that increase symmetry, improve comfort, reduce the risk of injury, decrease metabolic costs, and improve efficiency will directly benefit Veterans with TTAs by increasing their physical activity and function. Optimized prosthetic/bicycle fit guidelines will allow Veterans TTAs who were previously unable to comfortably ride a bicycle, as well as those currently riding a bicycle, to ride longer with less effort and discomfort, potentially leading to an improved quality of life. Moreover, the prosthetic/bicycle fit guidelines generated by this research will ensure that clinicians are able to fit Veterans with TTAs to bicycles more effectively, leading to shorter appointment times and fewer revisits due to enhanced function and reduced comorbidities.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Transtibial Amputation | – | Other: Prosthetic/Bicycle ConfigurationThe investigators will recruit participants with unilateral transtibial amputations who are at or above a K3 Medicare functional classification level (MFCL), and 18-55 years old. A K3 MFCL means that a person has the ability or potential for ambulation with variable cadence. A person at K3 MFCL is a typical community ambulator who has the ability to traverse most environmental barriers and may have vocational, therapeutic or exercise activity that demands prosthetic use beyond simple locomotion. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The investigators will recruit 15 subjects with unilateral transtibial amputations from the VA Jewell Clinic, locally, and nationally.
Key inclusion criteria (4 listed)
- One amputation below the knee
- At least 1 year of experience using a prosthesis
- No current problems with the prosthesis or residual limb
- At or above a K3 Medicare Functional Classification Level
Key exclusion criteria (5 listed)
- Poor general health
- Difficulty with mobility
- Problems with balance or dizziness
- Current serious musculoskeletal injury besides that associated with an amputation
- Cardiovascular, pulmonary, or neurological disease or disorder
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/Bicycle ConfigurationThe investigators will measure the biomechanics (motion, forces, and muscle activity) and metabolic rates while subjects ride using an initial bike fit and three taller pylon lengths (PL) for the affected leg (AL) in increments of 6.8 mm using a pedal attachment position (PAP) beneath the prosthetic forefoot. Then, using the optimal (most efficient) PL, the investigators will measure the biomechanics and metabolic rates while subjects ride using three shorter crank arm lengths (CALs) for the AL in decrements of 6.8 mm using a PAP beneath the prosthetic forefoot. On Day 2, the investigators will repeat the protocol of Day 1, but have riders use a PAP beneath the pylon for their AL. | Other | Participants with Transtibial Amputation |
Primary outcome
Mechanical Crank Power Output
Time frame: Data were collected over 2 days per subject
The investigators calculated crank power output (W/kg) from the product of pedal torque and velocity and normalized this to participant body mass while participants rode at 1.5 W/kg using different prosthetic and bicycle configurations (pylon length, crank arm length, and pedal attachment position).
Net Metabolic Power
Time frame: Data were collected over 2 days per subject
The investigators measured net metabolic power (W/kg) using an equation that considers rates of oxygen consumption and carbon dioxide production and normalized this to participant body mass while participants rode at 1.5 W/kg using different prosthetic and bicycle configurations (pylon length, crank arm length, and pedal attachment position).
Perceived Comfort (Visual Analog Scale (VAS))
Time frame: Data were collected over 2 days per subject
The investigators measured comfort with a questionnaire that has a range of 0-10 that indicates terrible to excellent, respectively, after participants rode at 1.5 W/kg using different prosthetic and bicycle configurations (pylon length, crank arm length, and pedal attachment position).
Perceived Satisfaction (Prosthesis Evaluation Questionnaire (PEQ))
Time frame: Data were collected over 2 days per subject
The investigators measured satisfaction with a questionnaire that has a range of 0-10 that indicates extremely dissatisfied to extremely satisfied, respectively, after participants rode at 1.5 W/kg using different prosthetic and bicycle configurations (pylon length, crank arm length, and pedal attachment position).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38768009Allen SP, Diaz GB, Grabowski AM. The Effect of Unequal Crank Arm Lengths and Cycling-Specific Prostheses for Recreational Riders with a Transtibial Amputation. Med Sci Sports Exerc. 2024 Oct 1;56(10):1976-1987. doi: 10.1249/MSS.0000000000003480. Epub 2024 May 15.
- Individual participant dataSharing planned: No
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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.
Alena Grabowski, PhD BA principal investigator
Rocky Mountain Regional VA Medical Center, Aurora, CO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation, run by VA Office of Research and Development 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 5 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 10 Dec 2024. 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 10 Dec 2024). 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?
Mechanical Crank Power Output (time frame: Data were collected over 2 days per subject). The study lists 4 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 NCT03828331, 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 10 Dec 2024.