Investigation of Physical Activity and Associated Factors in Lower Extremity Amputees

NCT03825432 | Completed

• 1 other identifier: ETK00-2018-0068
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to investigate the physical activity and related factors of individuals with lower extremity amputation. Participants in the study who have signed a voluntary consent form will be informed about the study first.Then, demographic information form will be started to be recorded in order to inform the socio-demographic characteristics of the participants and the information about amputation and prosthesis. The participants will be given the Timed Up and Go Test, L Test, Functional Reach Test and 2 Minute Walk Test. Following these tests, participants will continue with the scales to be answered by the participants themselves.These are respectively; Activity-Specific Balance Confidence Scale, Trinity Amputation and Prosthesis Experience Scale and Amputee Body Image Scale.Before the data is collected, individuals will be informed about the equipment to be used in the tests.An adequate number of trials will be conducted before the evaluation and use of the equipment in order to be familiar with the equipment. All assessments will be made by the same physiotherapist.

Conditions

Amputee

Keywords

Physical activity; Prosthesis

Outcome Measures

Primary Outcomes (1)

• Physical activity

  Physical activity of the subjects will be recorded by an accelerometer (Research Tracker 6, Version 3.1, Stay Healthy, Inc., Monrovia, USA) in kilocalories.

  3 days

Secondary Outcomes (9)

• Timed Up and Go Test

  The test will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 5 minutes.

• L Test

  The test will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 5 minutes.

• Functional Reach Test

  The test will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 2 minutes.

• 2 Minute Walk Test

  The test will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 3 minutes.

• Activities-Specific Balance Confidence Scale

  The scale will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 2 minutes.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Lower Limb Amputees

You may qualify if:

• Use prosthesis for at least 6 months
• years to 85 years old subjects
• Independent walking distance of 30 meters
• Individuals with unilateral amputation will be included

You may not qualify if:

• Bilateral amputees

Sponsors & Collaborators

• Eastern Mediterranean University: lead

Study Sites (1)

Eastern Mediterranean University

Mersin, 33010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Yasin YURT, Asst.Prof.

  Eastern Mediterranean University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: January 31, 2019
• Study Start: February 20, 2019
• Primary Completion: July 16, 2019
• Study Completion: July 16, 2019
• Last Updated: October 14, 2021

Record last verified: 2021-10

Locations

TU (1)