- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05095584
Validity and Reliability of The 3-Meter Backward Walk Test in Individuals With Lower Limb Amputation
Validity of 3 Meter Backward Test in Individuals With Amputations
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Ankara, Turkey, 06018
- Tezel Yıldırım Şahan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
validity and reliability of 3-meter backward walk test in lower limb amputation group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
validity and reliability of 3 meter backward walking test in lower limb amputees
Time Frame: 4 weeks
|
validity and reliability
|
4 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2021/298
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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