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Amputation; Traumatic, Limb, LowerNCT05444868

Validity and Reliability Study of Glittre Activities Of Daily Living Test in Amputees

An observational study of Amputation; Traumatic, Limb, Lower, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Amputation; Traumatic, Limb, Lower
How many people
66 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Jul 2022to 10 Jan 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

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

    Mersin

Other trials in Turkey (Türkiye)

About this study

Official title: Validity and Reliability Study of Glittre Activities Of Daily Living Test in Amputees Using Lower Extremity Prosthesis

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.

Read the detailed description

In individuals with lower extremity amputation, functions such as standing up, sitting, walking, turning, going up and down stairs, going up and down hills, jumping over steps, getting in and out of a car are required. There is no physical function test that simultaneously evaluates both the upper and lower extremities of individuals who have had lower extremity amputations. Therefore, we planned to perform the validity and reliability of the Glittre activities of daily living (ADL) test, which is used in COPD patients, for individuals who have had lower extremity amputation. The Glittre ADL test is the most widely used test to evaluate the performance of COPD patients in activities of daily living. The test is a simple test that can be easily applied and includes functional activities for the lower extremity and upper extremity.

RESEARCH QUESTIONS / HYPOTHESES:

  1. Is the Glittre ADL Test reliable in amputees using a lower extremity prosthesis?
  2. Is the Glittre ADL Test valid for evaluating amputees using a lower extremity prosthesis?

METHOD OF THE RESEARCH:

Glittre ADL Test:

It is a test that takes place within a distance of 10 m in total. This distance of 10 m will be divided into 2 in the middle by the ladder. Each rung of the ladder will be adjusted 17 cm high and 27 cm deep. Individuals will be asked to climb a 2-step ladder and then walk towards the shelf. The height of the shelves will be adjusted according to the shoulders and waist levels of the participants. It will place 3 pieces of 1 kg objects on the top shelf, one by one, first from the top shelf to the middle shelf, then from the middle shelf to the bottom shelf, from the bottom shelf to the middle shelf, and finally from the middle shelf to the top shelf. It is a test that takes place within a distance of 10 m in total. This distance of 10 m will be divided into 2 in the middle by the ladder. Each rung of the ladder will be adjusted 17 cm high and 27 cm deep. Individuals will be asked to climb a 2-step ladder and then walk towards the shelf. The height of the shelves will be adjusted according to the shoulders and waist levels of the participants. It will place 3 pieces of 1 kg objects on the top shelf, one by one, first from the top shelf to the middle shelf, then from the middle shelf to the bottom shelf, from the bottom shelf to the middle shelf, and finally from the middle shelf to the top shelf.

For the validity test; 2 minute walk test, functional reach test, timed get up and go test will be done and these tests will be examined in terms of Construct validity, Convergent validity and Discriminant validity.

For reliability test; Day 1 and Day 2 will be evaluated by the same physiotherapist. Day 3 will be evaluated by a different physiotherapist.

There will be 3 evaluations in 1 week and it will be planned to be 1 day between evaluations. Two assessments will be done by the same physiotherapist, while the third will be done by another physiotherapist.

Keywords
Amputees, functional capacity, Glittre ADL, prosthesis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glittre Activities Of Daily Living Test

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

    Measured: 3 months

Secondary outcomes (4)

  1. 2-Minute Walking Test

    The test to be carried out in the 30 meter long area will be marked at 3 meter intervals and the turning points will be determined by an object such as a traffic cone. We will ask the individual to walk the maximum distance in 2 minutes, and we will tell him that he can slow down and stop when he gets tired. When 2 minutes are completed with the stopwatch, we will ask the individual to stop and record the walking distance.

    Measured: 3 months

  2. Functional reach test:

    The patient will be asked to stand sideways next to the wall and wait with the shoulder flexed at 90 degrees, the elbow extended and the fist closed, without touching the arm close to the wall. The 3rd metacarpal head will be marked and the patient will be asked to lie down as far as he can without stepping, then the new location of the 3rd metacarpal head will be marked. Scoring will be determined by measuring the difference between the start and end position. 3 attempts will be made and the average of the last two trials will be taken.

    Measured: 3 months

  3. Timed get up and walk test

    The distance of 3 meters in front of the chair will be determined and the individual will be asked to get up from the chair and walk the determined distance.

    Measured: 3 months

  4. Trinity Amputation and Prosthetic Experience Scale (TAPES):

    TAPES consists of 2 parts. In the first part, psychosocial adaptation, activity limitation and prosthesis satisfaction are questioned, while in the second part, the average number of hours he wears the prosthesis, his physical capacity, general health, stump and phantom pain are questioned. A high score indicates high compliance. A high score in assessing activity limitation indicates activity limitation. Finally, the highest score that can be obtained in the prosthesis satisfaction subscale is 50, the lowest score is 10. A high score indicates that the individual is satisfied with the prosthesis.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2022
  2. Study start15 Jul 2022
  3. Primary completion30 Dec 2022
  4. Study completion10 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05444868
Sponsor's protocol ID
ETK00-2021-0085
Status last verified
Dec 2023
First submitted
22 Jun 2022
Last updated
27 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 11911519

  • 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.

    PubMed 25691167

  • 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.

    PubMed 39721062

Questions about this trial

What is this clinical trial studying?

An observational study of Amputation; Traumatic, Limb, Lower, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glittre Activities Of Daily Living Test (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05444868, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.

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