NCT05444868

Brief Summary

Glittre activities of daily living test is used in different populations. The test, which is valid and reliable in different populations, has not been validated in amputees. In our study, we wanted to investigate the validity and reliability of the Glittre activities of daily living test (Glittre ADL) test in amputees using a lower extremity prosthesis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

July 15, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2023

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

June 22, 2022

Last Update Submit

December 26, 2023

Conditions

Keywords

Amputeesfunctional capacityGlittre ADLprosthesis

Outcome Measures

Primary Outcomes (1)

  • Glittre Activities Of Daily Living Test

    How long individuals take the Glittre Daily Living Activities Test will be recorded in minutes.

    3 months

Secondary Outcomes (4)

  • 2-Minute Walking Test

    3 months

  • Functional reach test:

    3 months

  • Timed get up and walk test

    3 months

  • Trinity Amputation and Prosthetic Experience Scale (TAPES):

    3 months

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Those over the age of 18 who have been using a lower extremity prosthesis for at least 6 months will be included in the study.

You may qualify if:

  • People over the age of 18 who have had lower extremity amputation
  • Unilateral amputees using a lower extremity prosthesis for at least 6 months
  • Those who can walk at least 30 m independently

You may not qualify if:

  • Presence of ulcer on the stump
  • Lack of stump socket compatibility
  • Having a different orthopedic or neurological problem other than amputation
  • Having a cardiopulmonary problem that will prevent the test from being completed.
  • I ndividuals who cannot understand and follow commands

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Mediterranean University, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department

Mersin, Turkey (Türkiye)

Location

Related Publications (3)

  • Hatfield AG. Beyond the 10-m time: a pilot study of timed walks in lower limb amputees. Clin Rehabil. 2002 Mar;16(2):210-4. doi: 10.1191/0269215502cr484oa.

    PMID: 11911519BACKGROUND
  • Mason K, Chockalingam A, Prudhomme S, Stachenko S, Pearson T. Policy depot: a tool to build global capacity in cardiovascular health policy. Glob Heart. 2012 Mar;7(1):47-51. doi: 10.1016/j.gheart.2012.01.005. Epub 2012 Apr 13. No abstract available.

    PMID: 25691167BACKGROUND
  • Ciftci O, Yurt Y, Koltak C, Eker L. Validity and reliability of Glittre activities of daily living test in lower-limb prosthetic users. Prosthet Orthot Int. 2025 Dec 1;49(6):704-709. doi: 10.1097/PXR.0000000000000422. Epub 2024 Dec 24.

Related Links

Study Officials

  • Özge Çiftçi, Bachelor

    Eastern Mediterranean University

    PRINCIPAL INVESTIGATOR
  • Cansu Koltak, MSc

    Eastern Mediterranean University

    PRINCIPAL INVESTIGATOR
  • Yasin Yurt, PhD

    Eastern Mediterranean University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

June 22, 2022

First Posted

July 6, 2022

Study Start

July 15, 2022

Primary Completion

December 30, 2022

Study Completion

January 10, 2023

Last Updated

December 27, 2023

Record last verified: 2023-12

Locations