Lower Limb Amputation KneeNCT05095584
Validity and Reliability of The 3-Meter Backward Walk Test in Individuals With Lower Limb Amputation
A study testing 3 meter backward walk test in people with Lower Limb Amputation Knee and Lower Limb Amputation Below Knee (Injury), run by Tezel Yıldırım Şahan at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lower Limb Amputation Knee, Lower Limb Amputation Below Knee (Injury)
- What is being tested?
- 3 meter backward walk test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Aug 2021to 30 Oct 2021
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity of 3 Meter Backward Test in Individuals With Amputations
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.
- Being tested
- 3 meter backward walk test
- Keywords
- validity, fall, lower limb amputee, backward walking, reliability
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 meter backward walk testDiagnostic test
validity and reliability of 3-meter backward walk test in lower limb amputation group
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: 3 meter backward walk test |
What is being measured
The primary outcome is the main question the study is designed to answer.
validity and reliability of 3 meter backward walking test in lower limb amputees
validity and reliability
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start5 Aug 2021
- Primary completion10 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Limb Amputation KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- crosssectional
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tezel Yıldırım Şahan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tezel Yıldırım Şahan, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095584
- Sponsor's protocol ID
- 2021/298
- Status last verified
- Mar 2022
- First submitted
- 15 Oct 2021
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of 3 Meter Backward Test in Individuals With Amputations
- ClinicalTrials.gov ID
- NCT05095584
- Acronym / sponsor ID
- 2021/298
- Keywords
- validity, fall, lower limb amputee, backward walking, reliability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tezel Yıldırım ŞahanUniversity, hospital or other
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 10 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- crosssectional
| Arm | Type | Receives |
|---|---|---|
| validity and reliability of 3 meter backward walking test | Experimental | Diagnostic Test: 3 meter backward walk testThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 meter backward walk testvalidity and reliability of 3-meter backward walk test in lower limb amputation group | Diagnostic test | validity and reliability of 3 meter backward walking test |
Primary outcome
validity and reliability of 3 meter backward walking test in lower limb amputees
Time frame: 4 weeks
validity and reliability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Background: PubMed 33197801Abit 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 meter backward walk test in people with Lower Limb Amputation Knee and Lower Limb Amputation Below Knee (Injury), run by Tezel Yıldırım Şahan 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 4 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 16 Mar 2022. 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?
validity and reliability of 3 meter backward walking test in lower limb amputees (time frame: 4 weeks). 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 NCT05095584, which also lists 1 linked publication.
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 16 Mar 2022.