Amputation StumpNCT02436148
Reliability and Validity of the Finnish Version of the Prothesis Evaluation Questionnaire
An observational study of Amputation Stump, run by Helsinki University Central Hospital at 2 sites in Finland.
Trial summary
The present study assesses the reliability and validity of the Finnish version of Prothesis Evaluation Questionnaire. Major lower extremity amputees who use prosthesis are requited for the present study from the Helsinki and Uusimaa Hospital District and the Central Finland Health Care District. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Amputation Stump
- What is being tested?
- Prosthetic for major lower limb amputation
- How many people
- 140 participants
- Where
- 2 sitesFinland
- Study dates
- Mar 2015to Dec 2015
- How long will I take part?
- 1 Year
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with major lower extremity amputation who has been prothetized.
Who may be able to join
- Major lower extremity amputation Prothetization
Who cannot join
- Other amputation besides major lower extremity
- No prothesis in use
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Helsinki University Central Hospital
Helsinki, Uusimaa, 00029
Central Finland Central Hospital
Jyväskylä
About this study
The present study assesses the reliability and validity of the Finnish version of Prothesis Evaluation Questionnaire. Major lower extremity amputees who use prosthesis are requited for the present study from the Helsinki and Uusimaa Hospital District and the Central Finland Health Care District.
Read the detailed description
> 100 lower extremity prosthetic users with major lower extremity amputation are recruited for the present study. The aim is to assess the reliability and validity of the Finnish version of the Prothesis Evaluation Questionnaire (PEQ). The participants fill in a pre information form, the PEQ, the 15D health-related quality of life questionnaire, Houghton prothesis questionnaire, Locomotor Capabilities Index - 5, Prothesis Evaluation Questionnaire Mobility Section - 5. The psychometric abilities of the PEQ instrument are analyzed.
- Conditions
- Amputation Stump
- Being tested
- Prosthetic for major lower limb amputation
- Keywords
- PEQ validation study, Finland
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosthetic for major lower limb amputationOther
Prosthetic for major lower limb amputee
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the reliability and validity of the PEQ questionnaire
Measured: 1-10 years
Secondary outcomes (4)
Prothesis Evaluation Questionnaire
Measured: 1-10 years
Houghton prothesis user score
Measured: 1-10 years
Locomotor Capabilities Index - 5
Measured: 1-10 years
Prothesis Evaluation Questionnaire Mobility Section - 5
Measured: 1-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation StumpStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jussi Repo, Helsinki University Central Hospital
- Investigators
- Erkki J Tukiainen, MD,PhD, Study director, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436148
- Sponsor's protocol ID
- 364/13/03/02/2014/1
- Status last verified
- Aug 2017
- First submitted
- 2 May 2015
- Last updated
- 16 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Finnish Version of the Prothesis Evaluation Questionnaire
- ClinicalTrials.gov ID
- NCT02436148
- Acronym / sponsor ID
- 364/13/03/02/2014/1
- Conditions
- Amputation Stump
- Keywords
- PEQ validation study, Finland
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 May 2015 (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 present study assesses the reliability and validity of the Finnish version of Prothesis Evaluation Questionnaire. Major lower extremity amputees who use prosthesis are requited for the present study from the Helsinki and Uusimaa Hospital District and the Central Finland Health Care District.
Detailed description
> 100 lower extremity prosthetic users with major lower extremity amputation are recruited for the present study. The aim is to assess the reliability and validity of the Finnish version of the Prothesis Evaluation Questionnaire (PEQ). The participants fill in a pre information form, the PEQ, the 15D health-related quality of life questionnaire, Houghton prothesis questionnaire, Locomotor Capabilities Index - 5, Prothesis Evaluation Questionnaire Mobility Section - 5. The psychometric abilities of the PEQ instrument are analyzed.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with major lower extremity amputation who has been prothetized.
Key inclusion criteria (1 listed)
- Major lower extremity amputation Prothetization
Key exclusion criteria (2 listed)
- Other amputation besides major lower extremity
- No prothesis in use
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 for major lower limb amputationProsthetic for major lower limb amputee | Other | – |
Primary outcome
Assessing the reliability and validity of the PEQ questionnaire
Time frame: 1-10 years
4 secondary outcomes
Prothesis Evaluation Questionnaire
Time frame: 1-10 years
Houghton prothesis user score
Time frame: 1-10 years
Locomotor Capabilities Index - 5
Time frame: 1-10 years
Prothesis Evaluation Questionnaire Mobility Section - 5
Time frame: 1-10 years
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 16 Aug 2017.
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Role of Perineural Catheter in Pain Control and Opioid Consumption After Major Amputation of Lower Limb
Lower Limb Surgery, Pain
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Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Recruiting
Hemocoll, Avitene, or Bone Wax for Cancellous Bone Bleeding After Single-Ray Amputation
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RecruitingPhase 2
Autologous Volar Fibroblast Injection Into the Stump Site of Amputees
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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.
Erkki J Tukiainen, MD,PhD study director
Helsinki University Central Hospital
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 Stump, run by Helsinki University Central Hospital at 2 sites in Finland.
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 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 16 Aug 2017. 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 Finland. 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?
Assessing the reliability and validity of the PEQ questionnaire (time frame: 1-10 years). 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 16 Aug 2017.