Stroke SyndromeNCT04229914
Validity Reliability of 3 Meter Backward Walk Test in Stroke Patients
A study testing stroke patinets in people with Stroke Syndrome and Balance; Distorted, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
The 3 m walk-back test is used to assess neuromuscular control, proprioception, protective reflexes, fall risk, and balance. In a study of healthy elderly adults, a 3-m walk-back test showed better diagnostic accuracy compared to the most commonly used measurement methods for falls in the past year. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke Syndrome, Balance; Distorted, Walking, Difficulty
- What is being tested?
- stroke patinets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2020to 11 Sep 2020
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 40 years or older,
- Getting a diagnosis of stroke,
- Not having cooperation and communication problems
- To be able to walk 10 m independently with or without device
Who cannot join
- Have a neurological or orthopedic problem other than stroke that will affect functionality and balance
- Individuals with contraindications for advanced cardiovascular disease and mobilization will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
The 3 m walk-back test is used to assess neuromuscular control, proprioception, protective reflexes, fall risk, and balance. In a study of healthy elderly adults, a 3-m walk-back test showed better diagnostic accuracy compared to the most commonly used measurement methods for falls in the past year. Reliability is extremely important, especially for research and clinical applications. In order to assess the risk of falling, measurement methods need to be reliable and change accurately over time. 3 m walk back test was found to be reliable in healthy elderly individuals. However, there are no studies investigating the validity and reliability of this test in stroke patients.
Read the detailed description
Balance; within the limits of the stability of the center of gravity can be controlled on the surface. Balance can be affected due to muscle weakness after stroke, abnormal muscle tone, loss of deep sensation and disturbances in vestibular mechanisms. Among all sensorimotor results of stroke, it is stated that the balance of postural control has the greatest effect on daily living activities and gait. Accurate assessment of balance in stroke patients is important in identifying appropriate aids for mobility, choosing an effective treatment program, determining safe and unsafe activities, and setting rehabilitation goals. The most common risk factor for falls is one of the most important risk factors for stroke. Therefore, reliable and accurate measurement of dynamic gait balance is an important issue in stroke patients.The 3 m walk-back test is used to assess neuromuscular control, proprioception, protective reflexes, fall risk, and balance. In a study of healthy elderly adults, a 3-m walk-back test showed better diagnostic accuracy compared to the most commonly used measurement methods for falls in the past year. Reliability is extremely important, especially for research and clinical applications. In order to assess the risk of falling, measurement methods need to be reliable and change accurately over time. 3 m walk back test was found to be reliable in healthy elderly individuals. However, there are no studies investigating the validity and reliability of this test in stroke patients.
- Conditions
- Stroke Syndrome, Balance; Distorted, Walking, Difficulty
- Being tested
- stroke patinets
- Medical subject headings
- Stroke, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stroke patinetsOther
3-m backwards walk test, timed up and go test, 10 m walk test, Berg BalanceTest, Functional Reach Test
| Study group | Role | What they receive |
|---|---|---|
| stroke patients | Other | Assessment Receives: Other: stroke patinets |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-m backwards walk test,
A distance of 3 m is measured and marked with black tape. Individuals are asked to follow the heel and black band. With the 'start' command they are asked to walk backwards quickly. When the distance of 3 m is completed, a stop is instructed. Individuals are not allowed to run during the test. They are allowed to look back if they wish. The assessor walks behind individuals throughout the test. The test is repeated 3 times, the averages are recorded
Measured: first day and second day
timed up and go test
A standard chair is used for testing. First, the patient is asked to sit on the chair. The patient is then asked to stand up and walk regularly at a distance of 3 meters with a predetermined length, then return to the chair after 3 meters.
Measured: first day
10 m walking test
In this test, the individual is asked to walk at his / her normal speed within a pre-measured 10-meter area and is started when the individual is at the starting line of the foot and terminated when he crosses the finish line.
Measured: first day
Berg balance test
The BBS consists of 14 items to directly monitor the maintenance of body balance during performance.
Measured: first day
Functional reach test
It is used to measure both the balance of the individual functionally and the amount of dynamic reach.
Measured: first day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start10 Jan 2020
- Primary completion30 Aug 2020
- Study completion11 Sep 2020
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 Stroke SyndromeStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Abit Kocaman, Kırıkkale University
- Investigators
- Ayşe A Abit Kocaman, Principal investigator, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229914
- Sponsor's protocol ID
- 3 Meter Backward Walk Test
- Status last verified
- Nov 2021
- First submitted
- 1 Jan 2020
- Last updated
- 23 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carter V, Jain T, James J, Cornwall M, Aldrich A, de Heer HD. The 3-m Backwards Walk and Retrospective Falls: Diagnostic Accuracy of a Novel Clinical Measure. J Geriatr Phys Ther. 2019 Oct/Dec;42(4):249-255. doi: 10.1519/JPT.0000000000000149.
PubMed 29095771
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity Reliability of 3 Meter Backward Walk Test in Stroke Patients
- ClinicalTrials.gov ID
- NCT04229914
- Acronym / sponsor ID
- 3 Meter Backward Walk Test
- Conditions
- Stroke Syndrome, Balance; Distorted, Walking, Difficulty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 11 Sep 2020 (actual)
- First posted
- 18 Jan 2020 (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.
The 3 m walk-back test is used to assess neuromuscular control, proprioception, protective reflexes, fall risk, and balance. In a study of healthy elderly adults, a 3-m walk-back test showed better diagnostic accuracy compared to the most commonly used measurement methods for falls in the past year. Reliability is extremely important, especially for research and clinical applications. In order to assess the risk of falling, measurement methods need to be reliable and change accurately over time. 3 m walk back test was found to be reliable in healthy elderly individuals. However, there are no studies investigating the validity and reliability of this test in stroke patients.
Detailed description
Balance; within the limits of the stability of the center of gravity can be controlled on the surface. Balance can be affected due to muscle weakness after stroke, abnormal muscle tone, loss of deep sensation and disturbances in vestibular mechanisms. Among all sensorimotor results of stroke, it is stated that the balance of postural control has the greatest effect on daily living activities and gait. Accurate assessment of balance in stroke patients is important in identifying appropriate aids for mobility, choosing an effective treatment program, determining safe and unsafe activities, and setting rehabilitation goals. The most common risk factor for falls is one of the most important risk factors for stroke. Therefore, reliable and accurate measurement of dynamic gait balance is an important issue in stroke patients.The 3 m walk-back test is used to assess neuromuscular control, proprioception, protective reflexes, fall risk, and balance. In a study of healthy elderly adults, a 3-m walk-back test showed better diagnostic accuracy compared to the most commonly used measurement methods for falls in the past year. Reliability is extremely important, especially for research and clinical applications. In order to assess the risk of falling, measurement methods need to be reliable and change accurately over time. 3 m walk back test was found to be reliable in healthy elderly individuals. However, there are no studies investigating the validity and reliability of this test in stroke patients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stroke patients | Other | Other: stroke patinetsAssessment |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 40 years or older,
- Getting a diagnosis of stroke,
- Not having cooperation and communication problems
- To be able to walk 10 m independently with or without device
Key exclusion criteria (2 listed)
- Have a neurological or orthopedic problem other than stroke that will affect functionality and balance
- Individuals with contraindications for advanced cardiovascular disease and mobilization will not be included in the study.
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 |
|---|---|---|
| stroke patinets3-m backwards walk test, timed up and go test, 10 m walk test, Berg BalanceTest, Functional Reach Test | Other | stroke patients |
Primary outcome
3-m backwards walk test,
Time frame: first day and second day
A distance of 3 m is measured and marked with black tape. Individuals are asked to follow the heel and black band. With the 'start' command they are asked to walk backwards quickly. When the distance of 3 m is completed, a stop is instructed. Individuals are not allowed to run during the test. They are allowed to look back if they wish. The assessor walks behind individuals throughout the test. The test is repeated 3 times, the averages are recorded
timed up and go test
Time frame: first day
A standard chair is used for testing. First, the patient is asked to sit on the chair. The patient is then asked to stand up and walk regularly at a distance of 3 meters with a predetermined length, then return to the chair after 3 meters.
10 m walking test
Time frame: first day
In this test, the individual is asked to walk at his / her normal speed within a pre-measured 10-meter area and is started when the individual is at the starting line of the foot and terminated when he crosses the finish line.
Berg balance test
Time frame: first day
The BBS consists of 14 items to directly monitor the maintenance of body balance during performance.
Functional reach test
Time frame: first day
It is used to measure both the balance of the individual functionally and the amount of dynamic reach.
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 23 Nov 2021.
- Background: PubMed 29095771Carter V, Jain T, James J, Cornwall M, Aldrich A, de Heer HD. The 3-m Backwards Walk and Retrospective Falls: Diagnostic Accuracy of a Novel Clinical Measure. J Geriatr Phys Ther. 2019 Oct/Dec;42(4):249-255. doi: 10.1519/JPT.0000000000000149.
- 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.
Ayşe A Abit Kocaman principal investigator
Kırıkkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stroke patinets in people with Stroke Syndrome and Balance; Distorted, run by Kırıkkale 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 4 inclusion and 2 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 23 Nov 2021. 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?
3-m backwards walk test, (time frame: first day and second day). The study lists 5 primary outcomes in all. 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 NCT04229914, 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 23 Nov 2021.