Traumatic Amputation of Lower ExtremitySEWNCT01340807
A Comparison of External Mechanical Work Between Different Prosthetic Feet
A study testing Specialized Functional Prosthetic Training in people with Traumatic Amputation of Lower Extremity, run by Miami VA Healthcare System at 1 site in United States.
Trial summary
Recent dysvascular and diabetic amputees as well as older, long-term traumatic amputees are at risk of functional decline, joint degeneration, skin breakdown and further limb loss due to the forces placed on the contralateral limb through prosthetic ambulation. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Amputation of Lower Extremity
- What is being tested?
- Specialized Functional Prosthetic Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jan 2011
- Phase
- Interventional
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and/or Females between the ages of 40 and 65. b. People with unilateral transtibial amputations for vascular reasons or from traumatic events.
- At the lowest level of function candidates will have the ability to use a prosthesis for ambulation on level surfaces at a fixed cadence.
- People with a diagnosis of diabetes mellitus and/or peripheral vascular disease leading to amputation or people who have been amputated as a result of trauma.
- People comfortably fitted with a prosthesis for a period of at least 6 months.
- Candidates who score within the range of 29 to 47 on the Amputee Mobility Predictor which would indicate that subjects achieved the minimum required score to be fitted with a prosthesis.
- Able to tolerate the testing protocol and would not fatigue at any time during testing.
- Men's shoe size should be between 7.5 (25 cm) and 12.5 (29 cm). i. Women's shoe size should be between 8.5 (25 cm) and 13.5 (29 cm).
Who cannot join
- People who weigh more than 255 pounds at baseline visit. People receiving renal dialysis b. People with severe cardiac or pulmonary disease limiting ability to exercise including angina or poorly controlled hypertension.
- People with neurological disorder such as or stroke that affecting ability to ambulate d. People with severe lower limb arthritis e. People with wound on non-amputated side f. People experiencing problems with prosthetic fit g. People with poor control of diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of External Mechanical Work Between Bionic and Conventional Prosthetic Feet in Transtibial Amputees During Functional Activities
Recent dysvascular and diabetic amputees as well as older, long-term traumatic amputees are at risk of functional decline, joint degeneration, skin breakdown and further limb loss due to the forces placed on the contralateral limb through prosthetic ambulation. If specialized prosthetic gait training and proper use of the appropriate prosthetic foot can decrease forces on the intact limb, the long term health and quality of life of veterans with amputations could be substantially improved. We will address two key questions:
Key Question 1: After receiving specialized gait training and a new prosthetic socket, will subjects demonstrate differences in gait symmetry and external mechanical work between the bionic and conventional prosthetic feet, while performing various functional activities.
Key Question 2: Can external mechanical work be used as a clinically friendly measure to differentiate between prosthetic feet?
Read the detailed description
The study examined the application of outcome measures to determine changes in function of unilateral transtibial amputees (TTAs) caused by specialized functional prosthetic training (training) and the use of four different prosthetic feet. Two self-report measures i.e. the Prosthetic Evaluation Questionnaire (PEQ-13) and Locomotor Capability Index (LCI-5), and three performance-based measures i.e. the Amputee Mobility Predictor (AMPPRO), Six-minute Walk Test (6MWT), and Step Activity Monitor (SAM) were utilized. Healthy unilateral Transtibial Amputees between the age of 40-65 will participate in the study. Subjects were tested at baseline, after receiving training with their existing prosthesis, and with the study socket and four prosthetic feet i.e. SACH, SAFE, Talux and PROPRIO FOOT over an 8-10 week period. Training was administered between testing sessions.
- Conditions
- Traumatic Amputation of Lower Extremity
- Being tested
- Specialized Functional Prosthetic Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specialized Functional Prosthetic TrainingOther
Also called Proshetic Feet
Each subject receives specialized functional prosthetic training
| Study group | Role | What they receive |
|---|---|---|
| Prosthetic Feet | Experimental | Randomized to 4 different prosthetic feet (SACH, SAFE, TALUX, and Proprio Foot) Receives: Other: Specialized Functional Prosthetic Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symmetry in External Work
Work done by the intact and prosthetic limb
Measured: up to 12 weeks
Secondary outcomes (1)
Self Report and Performance Based Assessment Instruments
PEQ-13, LCI-5, AMPPRO, 6MWT, and SAM.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2011 (estimated)
- Study startMar 2008
- Primary completionJan 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miami VA Healthcare System
- Sponsor type
- US federal agency
- Investigators
- Ronald Tolchin, DO, Principal investigator, Miami VAHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340807
- Sponsor's protocol ID
- 8497.01
- Other IDs
- 01
- Acronym
- SEW
- Status last verified
- Feb 2011
- First submitted
- 19 Apr 2011
- Last updated
- 25 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of External Mechanical Work Between Bionic and Conventional Prosthetic Feet in Transtibial Amputees During Functional Activities
- ClinicalTrials.gov ID
- NCT01340807
- Acronym / sponsor ID
- SEW / 8497.01
- Conditions
- Traumatic Amputation of Lower Extremity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Miami VA Healthcare SystemUS federal agency
- Study start
- Mar 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 25 Apr 2011 (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.
Recent dysvascular and diabetic amputees as well as older, long-term traumatic amputees are at risk of functional decline, joint degeneration, skin breakdown and further limb loss due to the forces placed on the contralateral limb through prosthetic ambulation. If specialized prosthetic gait training and proper use of the appropriate prosthetic foot can decrease forces on the intact limb, the long term health and quality of life of veterans with amputations could be substantially improved. We will address two key questions:
Key Question 1: After receiving specialized gait training and a new prosthetic socket, will subjects demonstrate differences in gait symmetry and external mechanical work between the bionic and conventional prosthetic feet, while performing various functional activities.
Key Question 2: Can external mechanical work be used as a clinically friendly measure to differentiate between prosthetic feet?
Detailed description
The study examined the application of outcome measures to determine changes in function of unilateral transtibial amputees (TTAs) caused by specialized functional prosthetic training (training) and the use of four different prosthetic feet. Two self-report measures i.e. the Prosthetic Evaluation Questionnaire (PEQ-13) and Locomotor Capability Index (LCI-5), and three performance-based measures i.e. the Amputee Mobility Predictor (AMPPRO), Six-minute Walk Test (6MWT), and Step Activity Monitor (SAM) were utilized. Healthy unilateral Transtibial Amputees between the age of 40-65 will participate in the study. Subjects were tested at baseline, after receiving training with their existing prosthesis, and with the study socket and four prosthetic feet i.e. SACH, SAFE, Talux and PROPRIO FOOT over an 8-10 week period. Training was administered between testing sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prosthetic Feet | Experimental | Other: Specialized Functional Prosthetic TrainingRandomized to 4 different prosthetic feet (SACH, SAFE, TALUX, and Proprio Foot) |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and/or Females between the ages of 40 and 65. b. People with unilateral transtibial amputations for vascular reasons or from traumatic events.
Key exclusion criteria (2 listed)
- People who weigh more than 255 pounds at baseline visit. People receiving renal dialysis b. People with severe cardiac or pulmonary disease limiting ability to exercise including angina or poorly controlled hypertension.
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 |
|---|---|---|
| Specialized Functional Prosthetic TrainingAlso: Proshetic FeetEach subject receives specialized functional prosthetic training | Other | Prosthetic Feet |
Primary outcome
Symmetry in External Work
Time frame: up to 12 weeks
Work done by the intact and prosthetic limb
1 secondary outcome
Self Report and Performance Based Assessment Instruments
Time frame: up to 12 weeks
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 25 Apr 2011.
Related trials for Traumatic Amputation of Lower Extremity
Recruiting
REsistance and LOADing Exercise for Bone Health
Amputation of Lower Limb Below Knee, Amputation, Traumatic
RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
Recruiting
Dual-Task Balance Training in Traumatic Lower-Limb Prosthesis Users
Lower Limb Amputation, Prosthesis Users
Active, not recruitingObservational study
Kinematics of Ewing Amputees
Lower Extremity Amputation, Trans-Tibial Amputation
Recruiting
Optimizing Gait Rehabilitation for Veterans With Non-traumatic Lower Limb Amputation
Transtibial Amputation, Peripheral Artery Disease
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.
Ronald Tolchin, DO principal investigator
Miami VAHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specialized Functional Prosthetic Training in people with Traumatic Amputation of Lower Extremity, run by Miami VA Healthcare 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 7 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 25 Apr 2011. 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?
Symmetry in External Work (time frame: up to 12 weeks). 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 25 Apr 2011.