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CompletedNCT05095584Updated Mar 16, 2022

Validity and Reliability of The 3-Meter Backward Walk Test in Individuals With Lower Limb Amputation

An interventional study of 3 meter backward walk test in Lower Limb Amputation Knee and Lower Limb Amputation Below Knee (Injury), sponsored by Tezel Yıldırım Şahan. Completed at 1 site in Turkey. Per ClinicalTrials.gov, last updated 2022-03-16.

Sponsored by Tezel Yıldırım Şahan · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Sex
All
01

Study summary

Clinicians are routinely required to make decisions about fall risk among lower limb prosthesis users. For these decisions, clinicians should use valid, reliable, quantitative, and multidimensional measures of balance test for individuals with lower-limb amputations. The objective of this study was therefore to establish, validity and reliability for 3 meter backward tests administered to established unilateral lower-limb amputations. This study included a total of 30 lower limb amputees [age (18-65) years]. 3 Meter Backward Walking Test, Rivermead Mobility Index, Timed Up and Go test (TUG) was applied to the patients. The second evaluation (retest) was carried out by the same physiotherapist two days following the first evaluation (test) in order to measure test-retest reliability.

Read the detailed description

Lower limb amputees (LLA) were recruited from local prosthetic clinics. The inclusion criteria were as follows: unilateral transtibial or transfemoral amputation due to traumatic, dysvascular, or oncologic causes, 18 years of age or older, one or more years of using a prosthesis (i.e., established users), and could walk independently for minimum 10 m). Patients unable to ambulate at least 10 m without an upper extremity assistive device (e.g., cane), have an orthopedic or neurological disease that might influence balance, with complications to their contralateral leg (e.g., joint replacement, arthritis, or wounds), have the severe vision and hearing impairment, amputation of a second limb and individuals with stump wounds and gait problems were not enrolled in the research. This study was conducted as a "test-retest" design and the psychometric properties of the 3-m backward walk test were examined in LLA. The Rivermead Mobility Index, 3-m backward walk test, Berg Balance Scale, Timed Up, and Go test was applied to the patients. An experienced physiotherapist performed all these tests. In order to measure test-retest reliability, the second evaluations (retest) were carried out by the same physiotherapist two days following the first evaluation (test). The same evaluator collected data in order to avoid the inter-rater variability error rate between the evaluations. The patient was evaluated at one time of the day for test and retest.

Participants were asked to walk backward within the 3-meter distance marked with black bands on the floor. Participants were asked to walk backward as soon as possible with the "walk" command, to stop at the end of 3 meters, and the elapsed time was recorded in seconds.

Individuals were allowed to look back if they wanted to. To prevent the individual from falling during walking backward and to support the individual, the physiotherapist who made the evaluation walked with an amputee. Measurements were made 3 times and the average time was recorded. During walking backward, there is a greater feeling of insecurity compared to walking forward and causes fear of falling. Therefore, the therapist stood approximately half a meter behind the patient during the test.

02

Conditions studied

  • Lower Limb Amputation Knee
  • Lower Limb Amputation Below Knee (Injury)

Keywords

  • validity
  • fall
  • lower limb amputee
  • backward walking
  • reliability
03

In context

Lead sponsor

This is the only study on the registry with Tezel Yıldırım Şahan as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • unilateral transtibial or transfemoral amputation due to traumatic, dysvascular, or oncologic causes,
  • 18 years of age or older,
  • one or more years of using a prosthesis (i.e., established users),
  • could walk independently for a minimum of 10 m).

Exclusion criteria

Exclusion Criteria:

  • ambulate at least 10 m without an upper extremity assistive device (e.g., cane),
  • have an orthopedic or neurological disease that might influence balance,
  • with complications to their contralateral leg (e.g., joint replacement, arthritis, or wounds),
  • have severe vision and hearing impairment,
  • amputation of a second limb and individuals with stump wounds and gait problems
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    validity and reliability of 3 meter backward walking test

    This study was conducted as "test-retest" design and the psychometric properties of 3-m backward walk test were examined in LLA. The Rivermead Mobility Index, 3-m backward walk test, Berg Balance Scale, Timed Up and Go test were applied to the patients. An experienced physiotherapist performed all these tests. In order to measure test-retest reliability, the second evaluations (retest) were carried out by the same physiotherapist two days following the first evaluation (test). A same evaluator collected data in order to avoid the inter-rater variability error rate between the evaluations. The patient was evaluated at one time of the day for test and retest.

    Diagnostic Test: 3 meter backward walk test

Interventions

  • Diagnostic test3 meter backward walk test

    validity and reliability of 3-meter backward walk test in lower limb amputation group

06

What researchers measure

Primary outcomes

  1. validity and reliability of 3 meter backward walking test in lower limb amputees

    validity and reliability

    Time frame: 4 weeks

07

Study locations

1 site
  • Tezel Yıldırım Şahan
    Ankara, 06018, Turkey
08

References and documents

Publications

  • Abit Kocaman A, Aydogan Arslan S, Ugurlu K, Katirci Kirmaci ZI, Keskin ED. Validity and Reliability of The 3-Meter Backward Walk Test in Individuals with Stroke. J Stroke Cerebrovasc Dis. 2021 Jan;30(1):105462. doi: 10.1016/j.jstrokecerebrovasdis.2020.105462. Epub 2020 Nov 13. PubMed 33197801 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05095584
Lead sponsor
Tezel Yıldırım Şahan
Responsible party
Tezel Yıldırım Şahan (Clinical Researcher, Hacettepe University) — Sponsor-investigator
First posted
Oct 27, 2021
Start date
Aug 5, 2021
Primary completion
Oct 10, 2021
Completion
Oct 30, 2021
Last update
Mar 16, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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