StrokeNCT04639453
Trunk Control Tests in Post-stroke Context: Validity and Reliability Study
An observational study of Stroke, run by Anne-Violette Bruynnel at 1 site in Switzerland.
Trial summary
Context: After stroke, most patients suffer from hemiparesis with variable functional consequences that can strongly impact autonomy in daily activities. Motor recovery is, therefore, an essential part of the therapeutic strategy in order to optimize the patient's capacities and functional autonomy. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Trunk strength with hand-held dynamometer, Balance Assessment in Sitting and Standing test (BASS) and Timed Up and Go test
- How many people
- 32 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2019to 29 Mar 2021
- Phase
- Observational
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We include a group of 32 individuals with post-stroke hemiparesis. These subjects will consist of males and females with a minimum age of 50 and a maximum of 80 years. The subjects should be able to understand the instructions and be able to sit for 30 seconds without assistance to perform the tests.
Who may be able to join
- Post stroke
- Subacute phase
- Able to stay stable in sitting position during 30 seconds
- Medical stability
- Able to understand the consign (Mini-Mental State Examination >22)
Who cannot join
- Medical complications
- Hearing disorders
- Previous pathologies associated with spinal disorders
- Back pain
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Hôpitaux Universitaires de Genève (Hôpital Beau-Séjour)
Geneva, 1206
About this study
Official title: Trunk Joint Positional Sense and Unstable Sitting Balance Tests in Patients With Hemiparesis Post-stroke: Validity and Reliability Study
Context:
After stroke, most patients suffer from hemiparesis with variable functional consequences that can strongly impact autonomy in daily activities. Motor recovery is, therefore, an essential part of the therapeutic strategy in order to optimize the patient's capacities and functional autonomy.
Read more
Some authors suggest that trunk control would be essential in the capacities of standing balance, transfer tasks and gait. However, no studies have tested the reliability and validity of proprioceptive and sitting balance clinical tests for patients with post-stroke hemiparesis. These tests would be very useful in advancing our understanding of trunk impairments and for clinicians to manage an appropriate treatment strategy.
Objective:
The main objective is to assess the reliability of the Trunk Positional Sense Test, the unstable sitting test with forceplate and the Modified Functional Reach Test (MFRT) in individuals with post-stroke hemiparesis. The secondary objectives is 1) to assess the validity of the Trunk Positional Sense Test and the unstable sitting test with forceplate, 2) to assess the validity of a phone inertial captors to assess the instable sitting.
Method. - Thirty-two individuals with subacute post-stroke hemiparesis will be included in this study. After clinical tests (trunk strength, Balance Assessment in Standing and Sitting, Timed Up and Go test), the MFRT, Trunk Positional Sense Test and unstable sitting will be evaluated by two physiotherapists in a first session (inter-rater reliability). After a rest of 2-4 h, a second similar session was conducted with the first physiotherapist (intra-rater reliability). For unstable seated balance, two tools will be used: the force platform and a smartphone.
Reliability will be tested by calculating the intraclass correlation (ICC) and Bland-Altman analysis. For trunk positional sense test and unstable sitting test, the validity will be tested with correlations with each clinical test. The validity, between forceplate variables and inertial phone variables, will be tested with correlations.
Perspectives. - The promotion of quality tests to assess patients in clinical practice is essential. The results of this study should provide knowledge for selecting the best trunk control tests to assess the individuals after stroke and to understand the influence of trunk control on functional activities.
- Conditions
- Stroke
- Being tested
- Trunk strength with hand-held dynamometer, Balance Assessment in Sitting and Standing test (BASS), Timed Up and Go test, Modified Functional Reach Test (MFRT), Joint Position sense test (trunk)
- Keywords
- Stroke, Trunk, Postural control, Reliability, Validity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trunk strength with hand-held dynamometerDiagnostic test
MicroFET 2 Handheld Dynamometer is a force evaluation testing device to evaluate the strength of various trunk muscle groups in flexion, extension, and lateral (N).
Balance Assessment in Sitting and Standing test (BASS)Diagnostic test
The BASS is a test to assess static and dynamic sitting and standing balance, which has been validated for post-stroke hemiparetic patients. Each test is evaluated by a score from "0" (patient needs external support) to "4" (stable without external help) for static condition and from "0" (no possibility to pick up objects) to "3" (objects picked up without external help) for dynamic condition. The maximal score (sitting, standing, static and dynamic) is 14 points.
Timed Up and Go testDiagnostic test
The participant sits on a chair, gets up, walks 3m, makes a half turn in 1m2, walks 3m and comes back to sit on the chair. The time (s) to complete the task is measured.
Modified Functional Reach Test (MFRT)Diagnostic test
The MFRT is a dynamic seated balance test that measures the trunk's ability to move forward, to the paretic and non paretic side (cm).
Joint Position sense test (trunk)Diagnostic test
The joint positional sense test of the trunk consists in evaluating the positional error of the trunk in the sagittal plane (mm) and in the frontal plane (mm) during a trunk flexion posture (target position).
Unstable sitting in a seesawDiagnostic test
This test evaluates the balance capacities of the subject in an unstable sitting position on a seesaw (mediolateral or anteroposterior instability) with forceplate and phone application using center of pressure variables: total displacement (mm), area (mm2), deltas (mm), mean velocity (mm/s) et maximal velocity (mm/s).
| Study group | Role | What they receive |
|---|---|---|
| Stroke | Individuals with post-stroke hemiparesis in subacute phase will be included in the study. Receives: Diagnostic Test: Trunk strength with hand-held dynamometer; Diagnostic Test: Balance Assessment in Sitting and Standing test (BASS); Diagnostic Test: Timed Up and Go test; Diagnostic Test: Modified Functional Reach Test (MFRT); Diagnostic Test: Joint Position sense test (trunk); Diagnostic Test: Unstable sitting in a seesaw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of trunk tests
The inter-rater reliability will be evaluated by comparing the test results of two physiotherapists administering the same tests (Trunk position sense, Modified Functional Reach Test, unstable sitting on a seesaw), and the intra-rater reliability will be evaluated by comparing the test results of two sessions (test-retest) which will be executed by the same tester, with the intra-class correlations coefficient (ICC) and Bland-Altman analysis.
Measured: The measures will be collected over a timeframe of 22 months
Secondary outcomes (2)
Construct validity
The validity of the three tests (Trunk position sense, Modified Functional Reach Test, unstable sitting on a seesaw) with clinical tests (Balance Assessment in standing and sitting, Trunk strength, Timed Up and Go Test) will be assessed with correlations (r).
Measured: The measures will be collected over a timeframe of 22 months
Concurrent validity
The validity between center of pressure variables (forceplate) and inertial captors' variables (phone) during the same unstable sitting balance tests on a seesaw will be assessed with correlations (r) and Bland Altman analysis.
Measured: The measures will be collected over a timeframe of 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start1 Jun 2019
- Primary completion29 Mar 2021
- Study completion29 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anne-Violette Bruynnel
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva
- Responsible party
- Sponsor-investigator, Anne-Violette Bruynnel, School of Health Sciences Geneva
- Investigators
- Anne-Violette Bruyneel, PhD, Principal investigator, School of Health Sciences Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639453
- Sponsor's protocol ID
- 83589
- Status last verified
- Mar 2021
- First submitted
- 16 Nov 2020
- Last updated
- 30 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Han J, Waddington G, Adams R, Anson J, Liu Y. Assessing proprioception: A critical review of methods. J Sport Health Sci. 2016 Mar;5(1):80-90. doi: 10.1016/j.jshs.2014.10.004. Epub 2015 Feb 3.
PubMed 30356896Jung K, Kim Y, Chung Y, Hwang S. Weight-shift training improves trunk control, proprioception, and balance in patients with chronic hemiparetic stroke. Tohoku J Exp Med. 2014 Mar;232(3):195-9. doi: 10.1620/tjem.232.195.
PubMed 24646921Katz-Leurer M, Fisher I, Neeb M, Schwartz I, Carmeli E. Reliability and validity of the modified functional reach test at the sub-acute stage post-stroke. Disabil Rehabil. 2009;31(3):243-8. doi: 10.1080/09638280801927830.
PubMed 18608433Learman KE, Benedict JA, Ellis AR, Neal AR, Wright JA, Landgraff NC. An exploration of trunk reposition error in subjects with acute stroke: An observational design. Top Stroke Rehabil. 2016 Jun;23(3):200-7. doi: 10.1080/10749357.2016.1138671. Epub 2016 Feb 5.
PubMed 27077979Morishita M, Amimoto K, Matsuda T, Arai Y, Yamada R, Baba T. Analysis of dynamic sitting balance on the independence of gait in hemiparetic patients. Gait Posture. 2009 Jun;29(4):530-4. doi: 10.1016/j.gaitpost.2008.12.005. Epub 2009 Jan 9.
PubMed 19138521Oh DS, Choi JD. The effect of motor imagery training for trunk movements on trunk muscle control and proprioception in stroke patients. J Phys Ther Sci. 2017 Jul;29(7):1224-1228. doi: 10.1589/jpts.29.1224. Epub 2017 Jul 15.
PubMed 28744053Ryerson S, Byl NN, Brown DA, Wong RA, Hidler JM. Altered trunk position sense and its relation to balance functions in people post-stroke. J Neurol Phys Ther. 2008 Mar;32(1):14-20. doi: 10.1097/NPT.0b013e3181660f0c.
PubMed 18463551
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trunk Joint Positional Sense and Unstable Sitting Balance Tests in Patients With Hemiparesis Post-stroke: Validity and Reliability Study
- ClinicalTrials.gov ID
- NCT04639453
- Acronym / sponsor ID
- 83589
- Conditions
- Stroke
- Keywords
- Stroke, Trunk, Postural control, Reliability, Validity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Anne-Violette BruynnelUniversity, hospital or other
- Collaborators
- University Hospital, Geneva
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 29 Mar 2021 (actual)
- Study completion
- 29 Mar 2021 (actual)
- First posted
- 20 Nov 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.
Context:
After stroke, most patients suffer from hemiparesis with variable functional consequences that can strongly impact autonomy in daily activities. Motor recovery is, therefore, an essential part of the therapeutic strategy in order to optimize the patient's capacities and functional autonomy.
Some authors suggest that trunk control would be essential in the capacities of standing balance, transfer tasks and gait. However, no studies have tested the reliability and validity of proprioceptive and sitting balance clinical tests for patients with post-stroke hemiparesis. These tests would be very useful in advancing our understanding of trunk impairments and for clinicians to manage an appropriate treatment strategy.
Objective:
The main objective is to assess the reliability of the Trunk Positional Sense Test, the unstable sitting test with forceplate and the Modified Functional Reach Test (MFRT) in individuals with post-stroke hemiparesis. The secondary objectives is 1) to assess the validity of the Trunk Positional Sense Test and the unstable sitting test with forceplate, 2) to assess the validity of a phone inertial captors to assess the instable sitting.
Method. - Thirty-two individuals with subacute post-stroke hemiparesis will be included in this study. After clinical tests (trunk strength, Balance Assessment in Standing and Sitting, Timed Up and Go test), the MFRT, Trunk Positional Sense Test and unstable sitting will be evaluated by two physiotherapists in a first session (inter-rater reliability). After a rest of 2-4 h, a second similar session was conducted with the first physiotherapist (intra-rater reliability). For unstable seated balance, two tools will be used: the force platform and a smartphone.
Reliability will be tested by calculating the intraclass correlation (ICC) and Bland-Altman analysis. For trunk positional sense test and unstable sitting test, the validity will be tested with correlations with each clinical test. The validity, between forceplate variables and inertial phone variables, will be tested with correlations.
Perspectives. - The promotion of quality tests to assess patients in clinical practice is essential. The results of this study should provide knowledge for selecting the best trunk control tests to assess the individuals after stroke and to understand the influence of trunk control on functional activities.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke | – | Diagnostic Test: Trunk strength with hand-held dynamometer, Diagnostic Test: Balance Assessment in Sitting and Standing test (BASS), Diagnostic Test: Timed Up and Go test, Diagnostic Test: Modified Functional Reach Test (MFRT), Diagnostic Test: Joint Position sense test (trunk), Diagnostic Test: Unstable sitting in a seesawIndividuals with post-stroke hemiparesis in subacute phase will be included in the study. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We include a group of 32 individuals with post-stroke hemiparesis. These subjects will consist of males and females with a minimum age of 50 and a maximum of 80 years. The subjects should be able to understand the instructions and be able to sit for 30 seconds without assistance to perform the tests.
Key inclusion criteria (5 listed)
- Post stroke
- Subacute phase
- Able to stay stable in sitting position during 30 seconds
- Medical stability
- Able to understand the consign (Mini-Mental State Examination >22)
Key exclusion criteria (4 listed)
- Medical complications
- Hearing disorders
- Previous pathologies associated with spinal disorders
- Back pain
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 |
|---|---|---|
| Trunk strength with hand-held dynamometerMicroFET 2 Handheld Dynamometer is a force evaluation testing device to evaluate the strength of various trunk muscle groups in flexion, extension, and lateral (N). | Diagnostic test | Stroke |
| Balance Assessment in Sitting and Standing test (BASS)The BASS is a test to assess static and dynamic sitting and standing balance, which has been validated for post-stroke hemiparetic patients. Each test is evaluated by a score from "0" (patient needs external support) to "4" (stable without external help) for static condition and from "0" (no possibility to pick up objects) to "3" (objects picked up without external help) for dynamic condition. The maximal score (sitting, standing, static and dynamic) is 14 points. | Diagnostic test | Stroke |
| Timed Up and Go testThe participant sits on a chair, gets up, walks 3m, makes a half turn in 1m2, walks 3m and comes back to sit on the chair. The time (s) to complete the task is measured. | Diagnostic test | Stroke |
| Modified Functional Reach Test (MFRT)The MFRT is a dynamic seated balance test that measures the trunk's ability to move forward, to the paretic and non paretic side (cm). | Diagnostic test | Stroke |
| Joint Position sense test (trunk)The joint positional sense test of the trunk consists in evaluating the positional error of the trunk in the sagittal plane (mm) and in the frontal plane (mm) during a trunk flexion posture (target position). | Diagnostic test | Stroke |
| Unstable sitting in a seesawThis test evaluates the balance capacities of the subject in an unstable sitting position on a seesaw (mediolateral or anteroposterior instability) with forceplate and phone application using center of pressure variables: total displacement (mm), area (mm2), deltas (mm), mean velocity (mm/s) et maximal velocity (mm/s). | Diagnostic test | Stroke |
Primary outcome
Reliability of trunk tests
Time frame: The measures will be collected over a timeframe of 22 months
The inter-rater reliability will be evaluated by comparing the test results of two physiotherapists administering the same tests (Trunk position sense, Modified Functional Reach Test, unstable sitting on a seesaw), and the intra-rater reliability will be evaluated by comparing the test results of two sessions (test-retest) which will be executed by the same tester, with the intra-class correlations coefficient (ICC) and Bland-Altman analysis.
2 secondary outcomes
Construct validity
Time frame: The measures will be collected over a timeframe of 22 months
Concurrent validity
Time frame: The measures will be collected over a timeframe of 22 months
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 30 Mar 2021.
- Background: PubMed 30356896Han J, Waddington G, Adams R, Anson J, Liu Y. Assessing proprioception: A critical review of methods. J Sport Health Sci. 2016 Mar;5(1):80-90. doi: 10.1016/j.jshs.2014.10.004. Epub 2015 Feb 3.
- Background: PubMed 24646921Jung K, Kim Y, Chung Y, Hwang S. Weight-shift training improves trunk control, proprioception, and balance in patients with chronic hemiparetic stroke. Tohoku J Exp Med. 2014 Mar;232(3):195-9. doi: 10.1620/tjem.232.195.
- Background: PubMed 18608433Katz-Leurer M, Fisher I, Neeb M, Schwartz I, Carmeli E. Reliability and validity of the modified functional reach test at the sub-acute stage post-stroke. Disabil Rehabil. 2009;31(3):243-8. doi: 10.1080/09638280801927830.
- Background: PubMed 27077979Learman KE, Benedict JA, Ellis AR, Neal AR, Wright JA, Landgraff NC. An exploration of trunk reposition error in subjects with acute stroke: An observational design. Top Stroke Rehabil. 2016 Jun;23(3):200-7. doi: 10.1080/10749357.2016.1138671. Epub 2016 Feb 5.
- Background: PubMed 19138521Morishita M, Amimoto K, Matsuda T, Arai Y, Yamada R, Baba T. Analysis of dynamic sitting balance on the independence of gait in hemiparetic patients. Gait Posture. 2009 Jun;29(4):530-4. doi: 10.1016/j.gaitpost.2008.12.005. Epub 2009 Jan 9.
- Background: PubMed 28744053Oh DS, Choi JD. The effect of motor imagery training for trunk movements on trunk muscle control and proprioception in stroke patients. J Phys Ther Sci. 2017 Jul;29(7):1224-1228. doi: 10.1589/jpts.29.1224. Epub 2017 Jul 15.
- Background: PubMed 18463551Ryerson S, Byl NN, Brown DA, Wong RA, Hidler JM. Altered trunk position sense and its relation to balance functions in people post-stroke. J Neurol Phys Ther. 2008 Mar;32(1):14-20. doi: 10.1097/NPT.0b013e3181660f0c.
- 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.
Anne-Violette Bruyneel, PhD principal investigator
School of Health Sciences Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Anne-Violette Bruynnel at 1 site in Switzerland.
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 5 inclusion and 4 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 30 Mar 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 Switzerland. 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?
Reliability of trunk tests (time frame: The measures will be collected over a timeframe of 22 months). 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 NCT04639453, which also lists 7 linked publications.
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 30 Mar 2021.