- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02436148
Reliability and Validity of the Finnish Version of the Prothesis Evaluation Questionnaire
August 14, 2017 updated by: Jussi Repo, Helsinki University Central Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
140
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Jyväskylä, Finland
- Central Finland Central Hospital
-
-
Uusimaa
-
Helsinki, Uusimaa, Finland, 00029
- Helsinki University Central Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 91 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with major lower extremity amputation who has been prothetized.
Description
Inclusion Criteria:
- Major lower extremity amputation Prothetization
Exclusion Criteria:
- Other amputation besides major lower extremity
- No prothesis in use
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Assessing the reliability and validity of the PEQ questionnaire
Time Frame: 1-10 years
|
1-10 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Prothesis Evaluation Questionnaire
Time Frame: 1-10 years
|
1-10 years
|
|
Houghton prothesis user score
Time Frame: 1-10 years
|
1-10 years
|
|
Locomotor Capabilities Index - 5
Time Frame: 1-10 years
|
1-10 years
|
|
Prothesis Evaluation Questionnaire Mobility Section - 5
Time Frame: 1-10 years
|
1-10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Erkki J Tukiainen, MD,PhD, Helsinki University Central Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
May 2, 2015
First Submitted That Met QC Criteria
May 5, 2015
First Posted (Estimate)
May 6, 2015
Study Record Updates
Last Update Posted (Actual)
August 16, 2017
Last Update Submitted That Met QC Criteria
August 14, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 364/13/03/02/2014/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Amputation Stump
-
Massachusetts Institute of TechnologyNational Institute for Biomedical Imaging and Bioengineering (NIBIB)CompletedAmputation StumpUnited States, Mexico
-
Brooke Army Medical CenterUniversity of WashingtonCompleted
-
Istituto Nazionale Assicurazione contro gli Infortuni...Scuola Superiore Sant'Anna di PisaCompleted
-
Gaziler Physical Medicine and Rehabilitation Education...CompletedLower Extremity Amputation | Residual Limb Pain | Stump NeuromaTurkey (Türkiye)
-
Jason HighsmithFlorida High Tech Corridor Council; Otto Bock HealthcareCompletedOther and Unspecified Complications of Amputation StumpUnited States
-
London Health Sciences CentreUnknownInfection | Amputation Wound | Amputation Stump Complication | Amputation Stump; Infection
-
Liberating Technologies, Inc.Vivonics, Inc.CompletedLower Limb Amputation Below Knee (Injury) | Amputation | Prosthesis User | Amputation; Traumatic, Leg, Lower | Limb; Absence, Congenital, Lower | Amputation StumpUnited States
-
Baskent UniversityAnkara Yildirim Beyazıt University; Gulhane School of MedicineCompletedAmputation | Amputation Stump | Amputees | Amputation of Knee | VascularisationTurkey
-
Liberating Technologies, Inc.Vivonics, Inc.TerminatedAmputation | Prosthesis | Prosthesis User | Amputation Stump | Amputees | Lower Limb DeformityUnited States
-
Centre hospitalier de l'Université de Montréal...Not yet recruitingAmputation Stump | Amputation Neuroma | Amputation, Traumatic/Surgery | Amputation, Surgical
Clinical Trials on Prosthetic for major lower limb amputation
-
Shirley Ryan AbilityLabCompletedAmputation | Amputation, Traumatic | Amputation; Traumatic, LimbUnited States
-
University Hospital, BrestActive, not recruitingAmputation | AlgoneurodystrophyFrance
-
Hvidovre University HospitalUnknownInflammation | MalnutritionDenmark
-
Beni-Suef UniversityCompletedEffect of Different Types of Aerobic Training on Diastolic Heart Failure PatientsEgypt
-
Central Jutland Regional HospitalAarhus University HospitalRecruitingHypertension | Peripheral Arterial Disease | Abdominal Aortic AneurysmsDenmark
-
Kafrelsheikh UniversityActive, not recruitingCritical Lower Limb Ischemia | AngioplastyEgypt
-
Hospices Civils de LyonCompletedPeripheral Arterial Occlusive Disease | Critical Limb Ischemia | Arterial Revascularization | Arterial Bypass SurgeryFrance
-
University of FaisalabadRecruiting
-
University of MichiganNot yet recruiting
-
The University of Hong Kong-Shenzhen HospitalUnknown