NCT05095584

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 5, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 27, 2021

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

2 months

First QC Date

October 15, 2021

Last Update Submit

March 15, 2022

Conditions

Keywords

validityfalllower limb amputeebackward walkingreliability

Outcome Measures

Primary Outcomes (1)

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

    validity and reliability

    4 weeks

Study Arms (1)

validity and reliability of 3 meter backward walking test

EXPERIMENTAL

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

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

validity and reliability of 3 meter backward walking test

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • unilateral transtibial or transfemoral amputation due to traumatic, dysvascular, or oncologic causes,
  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tezel Yıldırım Şahan

Ankara, 06018, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 33197801BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: crosssectional
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Researcher

Study Record Dates

First Submitted

October 15, 2021

First Posted

October 27, 2021

Study Start

August 5, 2021

Primary Completion

October 10, 2021

Study Completion

October 30, 2021

Last Updated

March 16, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations