Trans-tibial AmputationNCT01684501
Comparing Active and Passive Ankle-foot Prostheses
An observational study of Trans-tibial Amputation, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial summary
The purpose of this study is to perform a biomechanical study of a prototype prosthetic foot and evaluate if it provides a physiological generation of power at the ankle in transtibial amputees. The prosthetic foot is a prototype system that generates power via actuators (i.e. robotic system). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Trans-tibial Amputation
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Mar 2013
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adults with history of traumatic unilateral transtibial amputation
Who may be able to join
- weigh more than 200 lbs
- are high level ambulators corresponding to levels E to F of the Special Interest Group of Amputee Medicine (SIGAM) mobility grade
- have the ability to follow multi-step commands.
Who cannot join
- score level D on the SIGAM mobility grade
- have experienced 1 or more falls in the last month before the study
- have a residual limb length which does not allow for seven inches clearance of bracket attachment for the PowerFoot
- the residual limb must be stable in volume (no change in socket or socket padding in last 6 months) and without pain that limits function
- the sound-side (contralateral) lower extremity must be free of impediments that affect gait, range of motion, or limb muscle activity
- Any diagnosed cardiovascular, pulmonary, neurological, and/ or orthopedic conditions that would interfere with subject participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital Boston
Boston, Massachusetts, 02114
About this study
The purpose of this study is to perform a biomechanical study of a prototype prosthetic foot and evaluate if it provides a physiological generation of power at the ankle in transtibial amputees. The prosthetic foot is a prototype system that generates power via actuators (i.e. robotic system).
Read the detailed description
Subjects will be studied during level-ground walking. A camera-based motion capture system will be used to study the biomechanics of motion and evaluate if the pattern of ankle power generation by the prosthetic foot is physiological. In addition, the metabolic cost of ambulation will be monitored during walking at constant speed over a period of several minutes. The data will allow us to assess if the prosthetic foot leads to a decreased metabolic cost of ambulation compared to passive prosthetic feet.
- Conditions
- Trans-tibial Amputation
- Keywords
- prosthesis, amputees, gait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Amputees | Adults with history of traumatic unilateral transtibial amputation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle power generation
Ankle power derived using a camera-based motion capture system during walking
Measured: During the session trial (approx 10 minutes)
Secondary outcomes (1)
Metabolic cost of ambulation
Oxygen consumption during level-ground walking
Measured: During the session trial (approx 10 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2012 (estimated)
- Study startMay 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trans-tibial AmputationStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Bonato, Spaulding Rehabilitation Hospital
- Investigators
- Paolo Bonato, Principal investigator, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684501
- Sponsor's protocol ID
- 2010-P-000951
- Status last verified
- Apr 2017
- First submitted
- 7 Sep 2012
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Active and Passive Ankle-foot Prostheses
- ClinicalTrials.gov ID
- NCT01684501
- Acronym / sponsor ID
- 2010-P-000951
- Conditions
- Trans-tibial Amputation
- Keywords
- prosthesis, amputees, gait
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Study start
- May 2010 (actual)
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 13 Sep 2012 (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 purpose of this study is to perform a biomechanical study of a prototype prosthetic foot and evaluate if it provides a physiological generation of power at the ankle in transtibial amputees. The prosthetic foot is a prototype system that generates power via actuators (i.e. robotic system).
Detailed description
Subjects will be studied during level-ground walking. A camera-based motion capture system will be used to study the biomechanics of motion and evaluate if the pattern of ankle power generation by the prosthetic foot is physiological. In addition, the metabolic cost of ambulation will be monitored during walking at constant speed over a period of several minutes. The data will allow us to assess if the prosthetic foot leads to a decreased metabolic cost of ambulation compared to passive prosthetic feet.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amputees | – | –Adults with history of traumatic unilateral transtibial amputation |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adults with history of traumatic unilateral transtibial amputation
Key inclusion criteria (3 listed)
- weigh more than 200 lbs
- are high level ambulators corresponding to levels E to F of the Special Interest Group of Amputee Medicine (SIGAM) mobility grade
- have the ability to follow multi-step commands.
Key exclusion criteria (6 listed)
- score level D on the SIGAM mobility grade
- have experienced 1 or more falls in the last month before the study
- have a residual limb length which does not allow for seven inches clearance of bracket attachment for the PowerFoot
- the residual limb must be stable in volume (no change in socket or socket padding in last 6 months) and without pain that limits function
- the sound-side (contralateral) lower extremity must be free of impediments that affect gait, range of motion, or limb muscle activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ankle power generation
Time frame: During the session trial (approx 10 minutes)
Ankle power derived using a camera-based motion capture system during walking
1 secondary outcome
Metabolic cost of ambulation
Time frame: During the session trial (approx 10 minutes)
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 12 Apr 2017.
- 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.
Paolo Bonato principal investigator
Spaulding Rehabilitation Hospital
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 Trans-tibial Amputation, run by Spaulding Rehabilitation Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 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 12 Apr 2017. 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?
Ankle power generation (time frame: During the session trial (approx 10 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017.