NCT04276467

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

February 19, 2020

Status Verified

February 1, 2020

Enrollment Period

5 months

First QC Date

February 18, 2020

Last Update Submit

February 18, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 2 Minute Walk Test

    3 March 2021

  • Amputee Mobility Predictor

    3 March 2021

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Lower Limb Amputee

You may qualify if:

  • Unilateral and traumatic lower limb loss
  • Prosthesis use for at least 6 months

You may not qualify if:

  • Not speaking or understanding Turkish
  • Not having cognitive skills to perform the tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

February 18, 2020

First Posted

February 19, 2020

Study Start

April 1, 2020

Primary Completion

September 1, 2020

Study Completion

April 1, 2021

Last Updated

February 19, 2020

Record last verified: 2020-02