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NCT04276467 Clinical Trial

Development of the ICF Based Amputee Mobility Scale

Amputation Clinical Trial

Official title:
Development and Validation of the International Classification of Functioning Disability and Health (ICF) Based Amputee Mobility Scale

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04276467
Other study ID # GO 19/773
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2020
Est. completion date April 1, 2021

Study information
Verified date February 2020
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Lower limb amputation is a condition that reduces individuals' independence in daily life. Therefore, the main purpose of the rehabilitation process is to reintegrate the person as an independent and productive person as soon as possible. Although scales are frequently used in mobility evaluation in the clinic, they do not measure the advanced activities of patients. Therefore, the aim of the study is to obtain a comprehensive scale evaluating mobility in amputee. The mobility scale will be created using the two-round Delphi method. ICF (International Classification of Functioning Disability and Health) created by the World Health Organization, mobility subheading will be evaluated, and the questions that will be included in the scale will be compiled. In line with the data to be obtained from experts, a scale will be created.Scale and gold standard tests will be applied to patients so that validation of the scale will be investigated.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 120
Est. completion date April 1, 2021
Est. primary completion date September 1, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Unilateral and traumatic lower limb loss

- Prosthesis use for at least 6 months

Exclusion Criteria:

- Not speaking or understanding Turkish

- Not having cognitive skills to perform the tests

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hacettepe University

Outcome
Type Measure Description Time frame Safety issue
Primary 2 Minute Walk Test 3 March 2021
Primary Amputee Mobility Predictor 3 March 2021
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