AmputationNCT01750372
A Client-Based Outcome System for Individuals With Lower Limb Amputation
An observational study of Amputation, run by University of Washington at 2 sites in United States.
Trial summary
Standardized outcome measures can be used to document patient health outcomes and improve treatment of those requiring prosthetic and orthotic (O\&P) services. Though numerous instruments have been developed, existing measures of O\&P outcomes have serious shortcomings including limited evidence that the scores are… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation
- How many people
- 1,572 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2010to Mar 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Persons with lower limb amputation living in the United States
Who may be able to join
- be 18 years of age or older; (2) have a unilateral or bilateral amputation of the lower limb between the hip and knee or between the knee and ankle; (3) own and use a lower limb prostheses; (4) and be able to read, write, and understand spoken English.
Who cannot join
- do not currently use or do not intend to be fitted for a lower limb prosthesis; or (2) appear to have moderate to severe cognitive impairment, as evidenced by inconsistent responding to the study instruments.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
South Florida Veterans Affairs Foundation for Research and Education
Miami, Florida, 33125
University of Washington, UWCORR
Seattle, Washington, 98105
About this study
Standardized outcome measures can be used to document patient health outcomes and improve treatment of those requiring prosthetic and orthotic (O\&P) services. Though numerous instruments have been developed, existing measures of O\&P outcomes have serious shortcomings including limited evidence that the scores are responsive to clinical changes.
The investigators are developing the Prosthetic Limb Users Survey-Mobility (PLUS-M) using modern measurement methods to be a brief, precise and flexible measure of mobility for persons with lower limb amputation (LLA). The investigators propose the following objectives to achieve this goal.
Read more
Key objective 1: develop a measure (item bank) for measuring mobility in persons with lower limb loss
Key objective 2: study health profiles of lower limb prosthetic users
Key objective 3: validate the measure in a longitudinal study of people receiving replacement prosthetic limbs
Key objective 4: study longitudinal health patterns of persons with lower limb amputation
- Conditions
- Amputation
- Keywords
- Artificial limbs, Questionnaires, Mobility limitation
- Medical subject headings
- Mobility Limitation
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 |
|---|---|---|
| Persons with lower limb amputation | Persons with amputation below the hip and at or above the ankle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthetic Limb Users Survey of Mobility (PLUS-M)
PLUS-M is a self-reported measure of prosthetic mobility.
Measured: Single time point
Secondary outcomes (3)
Prosthesis Evaluation Questionnaire - Mobility Subscale (PEQ-MS) delivery of orthotics and prosthetics (O&P) services for persons with LLA.
The PEQ-MS is a self-reported measure of prosthetic mobility.
Measured: Single time point
Patient Reported Outcomes Measurement Information Systems (PROMIS) brief profile
The Patient Reported Outcomes Measurement Information System (PROMIS) is a suite of reliable, precise, and meaningful self-report instruments designed to assess patients' health. PROMIS-29 is a 29-item survey designed to evaluate patients in seven health domains: physical function, anxiety, depression, fatigue, sleep disturbance, social role-participation, and pain interference.
Measured: Single time point
Activities Specific Balance Confidence Scale (ABC)
The ABC is a self-reported measure of balance confidence.
Measured: Single time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startApr 2010
- Primary completionMar 2016
- Study completionMar 2016
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 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,572 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 J Hafner, Ph.D, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750372
- Sponsor's protocol ID
- 38227-G
- Status last verified
- May 2016
- First submitted
- 12 Dec 2012
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Morgan SJ, Kelly VE, Amtmann D, Salem R, Hafner BJ. Self-Reported Cognitive Concerns in People With Lower Limb Loss. Arch Phys Med Rehabil. 2016 Jun;97(6):912-8. doi: 10.1016/j.apmr.2016.01.010. Epub 2016 Feb 1.
PubMed 26836953Amtmann D, Morgan SJ, Kim J, Hafner BJ. Health-related profiles of people with lower limb loss. Arch Phys Med Rehabil. 2015 Aug;96(8):1474-83. doi: 10.1016/j.apmr.2015.03.024. Epub 2015 Apr 25.
PubMed 25917819Hafner BJ, Morgan SJ, Abrahamson DC, Amtmann D. Characterizing mobility from the prosthetic limb user's perspective: Use of focus groups to guide development of the Prosthetic Limb Users Survey of Mobility. Prosthet Orthot Int. 2016 Oct;40(5):582-90. doi: 10.1177/0309364615579315. Epub 2015 May 5.
PubMed 25944625Morgan SJ, Amtmann D, Abrahamson DC, Kajlich AJ, Hafner BJ. Use of cognitive interviews in the development of the PLUS-M item bank. Qual Life Res. 2014 Aug;23(6):1767-75. doi: 10.1007/s11136-013-0618-z. Epub 2014 Jan 20.
PubMed 24442531Gaunaurd I, Spaulding SE, Amtmann D, Salem R, Gailey R, Morgan SJ, Hafner BJ. Use of and confidence in administering outcome measures among clinical prosthetists: Results from a national survey and mixed-methods training program. Prosthet Orthot Int. 2015 Aug;39(4):314-21. doi: 10.1177/0309364614532865. Epub 2014 May 14.
PubMed 24827935Hafner BJ, Gaunaurd IA, Morgan SJ, Amtmann D, Salem R, Gailey RS. Construct Validity of the Prosthetic Limb Users Survey of Mobility (PLUS-M) in Adults With Lower Limb Amputation. Arch Phys Med Rehabil. 2017 Feb;98(2):277-285. doi: 10.1016/j.apmr.2016.07.026. Epub 2016 Aug 30.
PubMed 27590443
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Client-Based Outcome System for Individuals With Lower Limb Amputation
- ClinicalTrials.gov ID
- NCT01750372
- Acronym / sponsor ID
- 38227-G
- Conditions
- Amputation
- Keywords
- Artificial limbs, Questionnaires, Mobility limitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,572 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 17 Dec 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.
Standardized outcome measures can be used to document patient health outcomes and improve treatment of those requiring prosthetic and orthotic (O\&P) services. Though numerous instruments have been developed, existing measures of O\&P outcomes have serious shortcomings including limited evidence that the scores are responsive to clinical changes.
The investigators are developing the Prosthetic Limb Users Survey-Mobility (PLUS-M) using modern measurement methods to be a brief, precise and flexible measure of mobility for persons with lower limb amputation (LLA). The investigators propose the following objectives to achieve this goal.
Key objective 1: develop a measure (item bank) for measuring mobility in persons with lower limb loss
Key objective 2: study health profiles of lower limb prosthetic users
Key objective 3: validate the measure in a longitudinal study of people receiving replacement prosthetic limbs
Key objective 4: study longitudinal health patterns of persons with lower limb amputation
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persons with lower limb amputation | – | –Persons with amputation below the hip and at or above the ankle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons with lower limb amputation living in the United States
Key inclusion criteria (1 listed)
- be 18 years of age or older; (2) have a unilateral or bilateral amputation of the lower limb between the hip and knee or between the knee and ankle; (3) own and use a lower limb prostheses; (4) and be able to read, write, and understand spoken English.
Key exclusion criteria (1 listed)
- do not currently use or do not intend to be fitted for a lower limb prosthesis; or (2) appear to have moderate to severe cognitive impairment, as evidenced by inconsistent responding to the study instruments.
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
Prosthetic Limb Users Survey of Mobility (PLUS-M)
Time frame: Single time point
PLUS-M is a self-reported measure of prosthetic mobility.
3 secondary outcomes
Prosthesis Evaluation Questionnaire - Mobility Subscale (PEQ-MS) delivery of orthotics and prosthetics (O&P) services for persons with LLA.
Time frame: Single time point
Patient Reported Outcomes Measurement Information Systems (PROMIS) brief profile
Time frame: Single time point
Activities Specific Balance Confidence Scale (ABC)
Time frame: Single time point
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 18 May 2016.
- Background: PubMed 26836953Morgan SJ, Kelly VE, Amtmann D, Salem R, Hafner BJ. Self-Reported Cognitive Concerns in People With Lower Limb Loss. Arch Phys Med Rehabil. 2016 Jun;97(6):912-8. doi: 10.1016/j.apmr.2016.01.010. Epub 2016 Feb 1.
- Background: PubMed 25917819Amtmann D, Morgan SJ, Kim J, Hafner BJ. Health-related profiles of people with lower limb loss. Arch Phys Med Rehabil. 2015 Aug;96(8):1474-83. doi: 10.1016/j.apmr.2015.03.024. Epub 2015 Apr 25.
- Background: PubMed 25944625Hafner BJ, Morgan SJ, Abrahamson DC, Amtmann D. Characterizing mobility from the prosthetic limb user's perspective: Use of focus groups to guide development of the Prosthetic Limb Users Survey of Mobility. Prosthet Orthot Int. 2016 Oct;40(5):582-90. doi: 10.1177/0309364615579315. Epub 2015 May 5.
- Background: PubMed 24442531Morgan SJ, Amtmann D, Abrahamson DC, Kajlich AJ, Hafner BJ. Use of cognitive interviews in the development of the PLUS-M item bank. Qual Life Res. 2014 Aug;23(6):1767-75. doi: 10.1007/s11136-013-0618-z. Epub 2014 Jan 20.
- Background: PubMed 24827935Gaunaurd I, Spaulding SE, Amtmann D, Salem R, Gailey R, Morgan SJ, Hafner BJ. Use of and confidence in administering outcome measures among clinical prosthetists: Results from a national survey and mixed-methods training program. Prosthet Orthot Int. 2015 Aug;39(4):314-21. doi: 10.1177/0309364614532865. Epub 2014 May 14.
- Derived from this study: PubMed 27590443Hafner BJ, Gaunaurd IA, Morgan SJ, Amtmann D, Salem R, Gailey RS. Construct Validity of the Prosthetic Limb Users Survey of Mobility (PLUS-M) in Adults With Lower Limb Amputation. Arch Phys Med Rehabil. 2017 Feb;98(2):277-285. doi: 10.1016/j.apmr.2016.07.026. Epub 2016 Aug 30.
- The University of Washington Center on Outcomes Research in Rehabilitation (UWCORR)Link provided by the sponsor.
Related trials for Amputation
Recruiting
Hemocoll, Avitene, or Bone Wax for Cancellous Bone Bleeding After Single-Ray Amputation
Hemostasis, Surgical Blood Loss
Not yet recruitingPhase 4
Role of Perineural Catheter in Pain Control and Opioid Consumption After Major Amputation of Lower Limb
Lower Limb Surgery, Pain
Enrolling by invitation
Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients Using the Avior Knee
Transfemoral Amputees
Recruiting
Bio Leg: Advancing Mobility (BAM)
Amputation of Lower Limb Above Knee, Amputee
Recruiting
Impact of Footwear on Gait in Unilateral Transtibial Amputees
Transtibial Amputation, Lower Limb Amputation
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 J Hafner, Ph.D principal investigator
University of Washington
2 sites 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 University of Washington at 2 sites 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 1 inclusion and 1 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 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Prosthetic Limb Users Survey of Mobility (PLUS-M) (time frame: Single time point). 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 NCT01750372, 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 18 May 2016.