StrokeNCT04171401
Limits of Stability in Sitting in Healthy Controls and Participants Post Stroke
An observational study of Stroke and Balance; Distorted, run by KU Leuven.
Trial summary
In this cross-sectional study we will compare the limits of stability in non-ambulatory participants post stroke compared to healthy controls. This will be done by placing participants in a seated position on a force platform, that will measure centre of pressure displacements during a leaning task in multiple… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stroke, Balance; Distorted
- What is being tested?
- In-patient stroke rehabilitation.
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- 11 May 2015to 27 Jan 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population consists of patients post stroke which are severly affected and are unable to walk without help of one or two persons who help cary their weight or control their balance. Participants are in the subacute phase post stroke and are admitted to a rehabilitation programme at the UZ Pellenberg. Healthy controls were also included in this study.
Who may be able to join
- a stroke with clear hemiplegia (a previous stroke is accepted when complete recovery was achieved)
- being a patient at the UZ Pellenberg
- Functional Ambulation Catergory of two or less
- to be able to sit independently for 2 minutes
- to be cooperative enough to fulfill multiple Evaluations and tests
- to be able to understand simple instructions and be able to execute those.
- Age above 50
- to be able to stand independently for 2 minutes
Who cannot join
- to have musculoskeletal and/or other neurological disorders that could influence the protocol
- severe communication, memory or language disorders that could disturb the understanding of the research protocol.
- no signed informed consent
- a disorder that could influence balance capabilities
- Berg Balance Scale less than 50 Points
- no signed informed consent
About this study
Official title: Maximum Weight-shifts in Sitting in Non-ambulatory People With Stroke Are Related With Trunk Control and Balance in Sitting and Standing
In this cross-sectional study we will compare the limits of stability in non-ambulatory participants post stroke compared to healthy controls. This will be done by placing participants in a seated position on a force platform, that will measure centre of pressure displacements during a leaning task in multiple directions. The results of the limits of stability test will be compared to standard clinical Measures of trunk control and functional balance, to see if there is a relationship between both ways of measuring. And how balance and trunk control are affected in the subacute stroke population.
- Conditions
- Stroke, Balance; Distorted
- Being tested
- In-patient stroke rehabilitation.
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-patient stroke rehabilitation.Other
An in-patient multi-disciplinary stroke rehabilitation program was performed.
| Study group | Role | What they receive |
|---|---|---|
| Participants post stroke | Severly affected patients in the subacute phase post stroke that are unable to walk without the help of one or two therapists to assist for balance and weight-carrying. Participants were able to sit independently for two minutes. Participants post stroke performed limits of stability testing in sitting, and tests for trunk control and functional balance. Receives: Other: In-patient stroke rehabilitation. | |
| Healthy controls | Healthy control subjects who matched patients post stroke for age and gender, and had no limitations to perform measurements. Healthy controls performed limits of stability measurements and a clinical measurements for balance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limits of Stability Testing
The centre of pressure(COP) movement is measured while the patient is seated on a force platform and is asked by the software that is projected on a screen, to lean with the trunk in a certain direction and hold this position before going back to the starting position. The COP distance between start and end position is calculated, as well as the COP length of the trajectory that it takes the participant to reach his or her maximum leaning position.
Measured: Baseline
Berg Balance Scale
The Berg Balance Scale (BBS) is used to assess functional balance. The scale consists of 14 items, for each item the minimum score is 0 points, the maximum score is 4 points. A total amount of 56 points can be achieved on the Berg Balance Scale which indicates a normal balance for adults. A score lower than 45 points in elderly indicates that individuals may be at greater risk of falling.
Measured: Baseline
Trunk Impairment Scale
The Trunk Impairment Scale (TIS) assesses static and dynamic sitting balance and coordination of trunk movement. The test consists of 17 items with a minimum score of 0 and a maximum score of 23 points, which is calculated by adding up the scores from the subscales (0-7 Points for static sitting Balance, 0-10 Points for dynamic sitting Balance, 0-6 Points for coordination), with a higher scores for better trunk control.
Measured: Baseline
Trunk Control Test
The Trunk Control Tests consists of four items with a maximum score of 100 points. The patient is asked to turn in bed, come from lying to sitting at the bedside and stay seated at the bedside. A higher score shows better functioning.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start11 May 2015
- Primary completion27 Jan 2016
- Study completion27 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Principal investigator, Evelien Wiskerke, KU Leuven
- Investigators
- Geert Verheyden, Study director, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171401
- Sponsor's protocol ID
- S57757
- Status last verified
- Nov 2019
- First submitted
- 18 Nov 2019
- Last updated
- 20 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximum Weight-shifts in Sitting in Non-ambulatory People With Stroke Are Related With Trunk Control and Balance in Sitting and Standing
- ClinicalTrials.gov ID
- NCT04171401
- Acronym / sponsor ID
- S57757
- Conditions
- Stroke, Balance; Distorted
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Study start
- 11 May 2015 (actual)
- Primary completion
- 27 Jan 2016 (actual)
- Study completion
- 27 Jan 2016 (actual)
- First posted
- 20 Nov 2019 (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.
In this cross-sectional study we will compare the limits of stability in non-ambulatory participants post stroke compared to healthy controls. This will be done by placing participants in a seated position on a force platform, that will measure centre of pressure displacements during a leaning task in multiple directions. The results of the limits of stability test will be compared to standard clinical Measures of trunk control and functional balance, to see if there is a relationship between both ways of measuring. And how balance and trunk control are affected in the subacute stroke population.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants post stroke | – | Other: In-patient stroke rehabilitation.Severly affected patients in the subacute phase post stroke that are unable to walk without the help of one or two therapists to assist for balance and weight-carrying. Participants were able to sit independently for two minutes. Participants post stroke performed limits of stability testing in sitting, and tests for trunk control and functional balance. |
| Healthy controls | – | –Healthy control subjects who matched patients post stroke for age and gender, and had no limitations to perform measurements. Healthy controls performed limits of stability measurements and a clinical measurements for balance. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of patients post stroke which are severly affected and are unable to walk without help of one or two persons who help cary their weight or control their balance. Participants are in the subacute phase post stroke and are admitted to a rehabilitation programme at the UZ Pellenberg. Healthy controls were also included in this study.
Key inclusion criteria (8 listed)
- a stroke with clear hemiplegia (a previous stroke is accepted when complete recovery was achieved)
- being a patient at the UZ Pellenberg
- Functional Ambulation Catergory of two or less
- to be able to sit independently for 2 minutes
- to be cooperative enough to fulfill multiple Evaluations and tests
Key exclusion criteria (6 listed)
- to have musculoskeletal and/or other neurological disorders that could influence the protocol
- severe communication, memory or language disorders that could disturb the understanding of the research protocol.
- no signed informed consent
- a disorder that could influence balance capabilities
- Berg Balance Scale less than 50 Points
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 |
|---|---|---|
| In-patient stroke rehabilitation.An in-patient multi-disciplinary stroke rehabilitation program was performed. | Other | Participants post stroke |
Primary outcome
Limits of Stability Testing
Time frame: Baseline
The centre of pressure(COP) movement is measured while the patient is seated on a force platform and is asked by the software that is projected on a screen, to lean with the trunk in a certain direction and hold this position before going back to the starting position. The COP distance between start and end position is calculated, as well as the COP length of the trajectory that it takes the participant to reach his or her maximum leaning position.
Berg Balance Scale
Time frame: Baseline
The Berg Balance Scale (BBS) is used to assess functional balance. The scale consists of 14 items, for each item the minimum score is 0 points, the maximum score is 4 points. A total amount of 56 points can be achieved on the Berg Balance Scale which indicates a normal balance for adults. A score lower than 45 points in elderly indicates that individuals may be at greater risk of falling.
Trunk Impairment Scale
Time frame: Baseline
The Trunk Impairment Scale (TIS) assesses static and dynamic sitting balance and coordination of trunk movement. The test consists of 17 items with a minimum score of 0 and a maximum score of 23 points, which is calculated by adding up the scores from the subscales (0-7 Points for static sitting Balance, 0-10 Points for dynamic sitting Balance, 0-6 Points for coordination), with a higher scores for better trunk control.
Trunk Control Test
Time frame: Baseline
The Trunk Control Tests consists of four items with a maximum score of 100 points. The patient is asked to turn in bed, come from lying to sitting at the bedside and stay seated at the bedside. A higher score shows better functioning.
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 20 Nov 2019.
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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.
Geert Verheyden study director
KU Leuven
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Balance; Distorted, run by KU Leuven.
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 8 inclusion and 6 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 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Limits of Stability Testing (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2019.