Traumatic Amputation of Lower ExtremityNCT01784003
Characterizing Ankle Function During Sloped Locomotion for Prosthesis Development
An observational study of Traumatic Amputation of Lower Extremity, run by VA Eastern Colorado Health Care System at 1 site in United States.
Trial summary
The proposed study aims to characterize biological ankle joint function during walking and running on slopes in order to further develop advanced powered ankle-foot prostheses. Ankle joint torque and angle data will be collected from non-amputees while walking and running at multiple speeds and slopes. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Amputation of Lower Extremity
- What is being tested?
- Powered ankle-foot prosthesis
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Sep 2020
- Phase
- Observational
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Study 1: Non-amputee Study 2: Unilateral transtibial amputee Study 3: Unilateral transtibial amputee Study 4: Non-amputee Study 5: Unilateral transtibial amputee
Who may be able to join
- Study 1:
- Between 18-60 years old.
- Study 2 and 3:
- Between 18-60 years old.
- At least 1 year post-amputation
- no current problems with prosthesis or residual limb
Show all 15Show fewer
- At least a K3 level of ambulation
- Study 4:
- Between 18-45 years old
- Study 5:
- Between 18-45 years old
- At least 1 year post-amputation
- no current problems with prosthesis or residual limb
- Experience running with a passive prosthesis
- At least a K4 level of ambulation
Who cannot join
- Studies 1-5
- Cardiovascular, pulmonary, or neurological disease or disorder
- Musculoskeletal injury
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Boulder
Boulder, Colorado, 80309
About this study
The proposed study aims to characterize biological ankle joint function during walking and running on slopes in order to further develop advanced powered ankle-foot prostheses. Ankle joint torque and angle data will be collected from non-amputees while walking and running at multiple speeds and slopes. This data will be used to develop control parameters for a powered ankle-foot prosthesis. Then, these parameters will be implemented and tested in a powered prosthesis worn by people with below the knee amputations.
- Conditions
- Traumatic Amputation of Lower Extremity
- Being tested
- Powered ankle-foot prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Powered ankle-foot prosthesisDevice
| Study group | Role | What they receive |
|---|---|---|
| Non-amputee | People without an amputation will be recruited to participate in the study. | |
| Below the knee amputee | People with a unilateral transtibial amputation will be recruited to participate in the study. Receives: Device: Powered ankle-foot prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Force-measuring treadmill and motion capture
Measured: approximately 2 months
Metabolic analysis system
Measured: approximately 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startJun 2012
- Primary completionSep 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Traumatic Amputation of Lower ExtremityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784003
- Sponsor's protocol ID
- A7972W
- Status last verified
- Sep 2020
- First submitted
- 25 Jan 2013
- Last updated
- 10 Sep 2020
- Results posted
- No
Publications
Jeffers JR, Auyang AG, Grabowski AM. The correlation between metabolic and individual leg mechanical power during walking at different slopes and velocities. J Biomech. 2015 Aug 20;48(11):2919-24. doi: 10.1016/j.jbiomech.2015.04.023. Epub 2015 Apr 22.
PubMed 25959113Montgomery JR, Grabowski AM. The contributions of ankle, knee and hip joint work to individual leg work change during uphill and downhill walking over a range of speeds. R Soc Open Sci. 2018 Aug 29;5(8):180550. doi: 10.1098/rsos.180550. eCollection 2018 Aug.
PubMed 30225047Pickle NT, Grabowski AM, Jeffers JR, Silverman AK. The Functional Roles of Muscles, Passive Prostheses, and Powered Prostheses During Sloped Walking in People With a Transtibial Amputation. J Biomech Eng. 2017 Nov 1;139(11):1110051-11100511. doi: 10.1115/1.4037938.
PubMed 28975280Pickle NT, Grabowski AM, Auyang AG, Silverman AK. The functional roles of muscles during sloped walking. J Biomech. 2016 Oct 3;49(14):3244-3251. doi: 10.1016/j.jbiomech.2016.08.004. Epub 2016 Aug 6.
PubMed 27553849Montgomery JR, Grabowski AM. Use of a powered ankle-foot prosthesis reduces the metabolic cost of uphill walking and improves leg work symmetry in people with transtibial amputations. J R Soc Interface. 2018 Aug;15(145):20180442. doi: 10.1098/rsif.2018.0442.
PubMed 30158189Jeffers JR, Grabowski AM. Individual Leg and Joint Work during Sloped Walking for People with a Transtibial Amputation Using Passive and Powered Prostheses. Front. Robot. AI, 22 December 2017. https://doi.org/10.3389/frobt.2017.00072
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Ankle Function During Sloped Locomotion for Prosthesis Development
- ClinicalTrials.gov ID
- NCT01784003
- Acronym / sponsor ID
- A7972W
- Conditions
- Traumatic Amputation of Lower Extremity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Study start
- Jun 2012
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 5 Feb 2013 (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.
The proposed study aims to characterize biological ankle joint function during walking and running on slopes in order to further develop advanced powered ankle-foot prostheses. Ankle joint torque and angle data will be collected from non-amputees while walking and running at multiple speeds and slopes. This data will be used to develop control parameters for a powered ankle-foot prosthesis. Then, these parameters will be implemented and tested in a powered prosthesis worn by people with below the knee amputations.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-amputee | – | –People without an amputation will be recruited to participate in the study. |
| Below the knee amputee | – | Device: Powered ankle-foot prosthesisPeople with a unilateral transtibial amputation will be recruited to participate in the study. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Study 1: Non-amputee Study 2: Unilateral transtibial amputee Study 3: Unilateral transtibial amputee Study 4: Non-amputee Study 5: Unilateral transtibial amputee
Key inclusion criteria (15 listed)
- Between 18-60 years old.
- Between 18-60 years old.
- At least 1 year post-amputation
- no current problems with prosthesis or residual limb
- At least a K3 level of ambulation
Key exclusion criteria (3 listed)
- Studies 1-5
- Cardiovascular, pulmonary, or neurological disease or disorder
- Musculoskeletal injury
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 |
|---|---|---|
| Powered ankle-foot prosthesis | Device | Below the knee amputee |
Primary outcome
Force-measuring treadmill and motion capture
Time frame: approximately 2 months
Metabolic analysis system
Time frame: approximately 2 months
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 10 Sep 2020.
- Results publication: PubMed 25959113Jeffers JR, Auyang AG, Grabowski AM. The correlation between metabolic and individual leg mechanical power during walking at different slopes and velocities. J Biomech. 2015 Aug 20;48(11):2919-24. doi: 10.1016/j.jbiomech.2015.04.023. Epub 2015 Apr 22.
- Results publication: PubMed 30225047Montgomery JR, Grabowski AM. The contributions of ankle, knee and hip joint work to individual leg work change during uphill and downhill walking over a range of speeds. R Soc Open Sci. 2018 Aug 29;5(8):180550. doi: 10.1098/rsos.180550. eCollection 2018 Aug.
- Results publication: PubMed 28975280Pickle NT, Grabowski AM, Jeffers JR, Silverman AK. The Functional Roles of Muscles, Passive Prostheses, and Powered Prostheses During Sloped Walking in People With a Transtibial Amputation. J Biomech Eng. 2017 Nov 1;139(11):1110051-11100511. doi: 10.1115/1.4037938.
- Results publication: PubMed 27553849Pickle NT, Grabowski AM, Auyang AG, Silverman AK. The functional roles of muscles during sloped walking. J Biomech. 2016 Oct 3;49(14):3244-3251. doi: 10.1016/j.jbiomech.2016.08.004. Epub 2016 Aug 6.
- Results publication: PubMed 30158189Montgomery JR, Grabowski AM. Use of a powered ankle-foot prosthesis reduces the metabolic cost of uphill walking and improves leg work symmetry in people with transtibial amputations. J R Soc Interface. 2018 Aug;15(145):20180442. doi: 10.1098/rsif.2018.0442.
- Results publicationJeffers JR, Grabowski AM. Individual Leg and Joint Work during Sloped Walking for People with a Transtibial Amputation Using Passive and Powered Prostheses. Front. Robot. AI, 22 December 2017. https://doi.org/10.3389/frobt.2017.00072
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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?
An observational study of Traumatic Amputation of Lower Extremity, run by VA Eastern Colorado Health Care System 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 15 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 10 Sep 2020. 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?
Force-measuring treadmill and motion capture (time frame: approximately 2 months). The study lists 2 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 NCT01784003, which also lists 6 linked publications.
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 Sep 2020.