Sensory DisorderNCT03019432
Perception of Verticality After Stroke
An observational study of Sensory Disorder and Stroke, run by Universiteit Antwerpen at 1 site in Belgium.
Trial summary
In this study, the researchers will investigate whether the E-effect is present in stroke subjects both on the subjective visual and postural vertical test. In addition, researchers will investigate the impact of the loss of different sensory information sources on the sensory reweighting strategies and perception of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sensory Disorder, Stroke, Cerebrovascular Disorders
- What is being tested?
- Observational clinical assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2017to Feb 2017
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: stroke patients within 3 months poststroke hospitalized in a Belgian Rehabilitation Hospital
Who may be able to join
- Adult first-stroke patients
- Maximum 3 months post-stroke at inclusion
- Patients attending a rehabilitation program in the Rehabilitation Hospital Revarte, Belgium
Who cannot join
- An age above 65
- Neurological, except stroke, and orthopaedic impairments influencing outcome measures
- Brainstem, cerebellar or multiple lesions
- An ischemic or hemorrhagic etiology
- Pre-existing co-morbid conditions that may affect vision and somatosensory function
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Rehabilitation Hospital Revarte
Wilrijk, Antwerp, 2650
Wim Saeys, Dr., 496804347, wim.saeys@uantwerpen.be
Steven Truijen, Prof Dr., Steven.truijen@uantwerpen.be
About this study
Official title: The Effect of Sensory Loss on the E-effect in Post-stroke Patients. A New Insight in Sensory Weighting Strategies
In this study, the researchers will investigate whether the E-effect is present in stroke subjects both on the subjective visual and postural vertical test. In addition, researchers will investigate the impact of the loss of different sensory information sources on the sensory reweighting strategies and perception of verticality by measuring the effect of somatosensory loss on the E-effect.
Read the detailed description
Postural control emerges from the interaction between the task, the environment and the individual. Within the individual, an efficient interaction between motor, sensory and neural systems is needed in order to maintain postural control.(1) One of the neural processes is the integration of afferent information such as visual, vestibular and somatosensory input to construct a body-centred frame of reference in the gravitational environment.(2) This frame of reference must be vertically aligned with the gravitational vector to ensure axial extension of the body keeping the centre of gravity within the base of support.
Each of the sensory modalities has a relative load contribution in the estimation of verticality depending on the task and the environment.(3) In healthy subjects, when certain modalities are absent or information seems biased e.g. walking in complete darkness, more weight is given to other sensory input sources.(1) This reweighting of sensory information is therefore key in postural responses in humans.
However, sensory reweighting is not always adequate when certain modalities are biased. In verticality perception, when the roll tilt of the head is less than 60°-70°, a contralateral deviation of the subjective vertical has been reported.(4) This is called the E-effect and has been observed in both the Subjective Visual Vertical test (SVV) and the Subjective Postural Vertical test (SPV).(5, 6) Furthermore, studies have shown that also somatosensory loss has a negative impact on perceiving verticality in patients after stroke.(7) In our opinion, when less afferent input sources are present, adequate estimation of the earth vertical will be more difficult. Since, studies show that verticality perception is highly related to postural control(8, 9), this is of major importance. In neurological conditions such as stroke sensory input sources are often affected, leading to fewer options in sensory reweighting strategies.(10) In this study, the researchers will explore verticality perception and sensory reweighting strategies in stroke subjects. At first, the researchers will investigate whether the E-effect also occurs in our sample of stroke subjects. Secondly, they will investigate the effect of somatosensory loss on the extent of the E-effect. It can be hypothesized that when patients have no sensory loss, more secondary afferent input is available to improve estimation of the vertical and therefore less misleading by the head-on-body tilt.
Patients and methods Study design A cohort study was designed to investigate whether the E-effect occurs in people after stroke. In addition, the effect of somatosensory loss on the extent of the E-effect will be investigated to provide further insights in the sensory reweighting strategies. Ethical approval was given by the ethical committee with registration number B300201630358 in accordance with the Declaration of Helsinki 1975, revised Hong Kong 1989 Patients Patients were recruited from the stroke population of the rehabilitation hospital Revarte, Antwerp, Belgium. All patients with a history of first stroke attending a rehabilitation program were eligible for inclusion. Patients who had an age above 80; other neurological and orthopaedic impairments as well as brainstem, cerebellar or multiple lesions were excluded. Only strokes with an ischemic or hemorrhagic etiology were included. Patients were also excluded when the subjects had pre-existing co-morbid conditions that may affect vision and somatosensory function. In addition, patients with visuospatial neglect and pusher behaviour were also excluded as this can affect verticality perception. This was examined by a neuropsychologist and the use of the Scale of Contraversive Pushing (SCP)(11). In addition, patients had to perform the assessment within three months post-stroke. Prior to inclusion, the participants were asked whether they understand the instructions of tests and to sign a written informed consent.
Outcome measures Rivermead assessment for somatosensory Performance The Rivermead Assessment for Somatosensory Performance (RASP) measures different somatosensory modalities on the face, hands and feet and has been noted to be a reliable and standardized assessment. Six tests are administered on each of the ten (five left and five right) test regions on the face; hands and feet, two tests are administered on only the face and palm of the hands. During testing eyes of the participants are closed. These eight tests can be divided into six primary and two secondary tests of sensation. Six trials are executed on each of the ten test regions, for two of the tests sham trials were given. Sham trials increase the patient's internal reliability. Patients were excluded from the statistical analysis if they had more than five false positive replies, suggested by Winward et al.(12) Subjective Visual Vertical (SVV) The Difra Vertitest type D107201 (Difra, Welkenraedt, Belgium) was used for SVV assessment. The device has an accuracy of 0.1°. A laser bar is projected at a distance of 2.5m on an opposing wall and on an altitude of 1.5m. The patients are seated in front of the device on a chair without any arm- or backrests. Patients with no adequate sitting balance were assessed while seated in their wheelchair. The room was darkened and five minutes of waiting period was given allowing the subject to adjust the darkness. Both researcher and participant obtained a remote to allow rotating the laser bar either clockwise (right) or counter clockwise (left). The researcher's remote showed a display with the amount of deviation in relation to the earth's gravitational vector. The researcher made the laser bar invisible and rotated it in a specific angle in relation to the earth vertical. Subsequently, the line was shown after which the patient had to place the line in upright position again with his nonhemiplegic hand on the remote control. The amount of deviation of each starting roll position was different for each trial. A specified order was followed: first the line was placed in 20° counter clockwise, 10° clockwise, 5° counter clockwise and 0° according to the earth vertical, followed by 5° clockwise, 10° counter clockwise and finally 20° clockwise. This series was executed three times. During the first series the patient was asked to hold the head in normal upright position, followed by a series with the head tilted to the left (while the head was bent the subjects needed to keep their trunk upright) and finally a series with the head tilted to the right side. The clockwise rotation is shown positively and the counter clockwise negatively. The patients did not receive any feedback about their performance during assessment.
Subjective Postural Vertical (SPV) The rotation chair works on hydraulic pumps and has a height of 1m. On the back of the chair, a Mitutoyo digital protractor pro 3600 (Belgium) was mounted. This allowed measurement of the deviation in relation to the earth vertical with an accuracy of 0.01°. Both the researcher and patient were given a remote to rotate the chair clockwise (right) and counter clockwise (left). Movements were restricted in the frontal plane. Before the assessment started the patient was blindfolded, depriving the subjects of visual information when readjusting the chair to earth vertical. The researcher rotated the chair as in the procedure of SVV (starting roll position of the chair). The head-on-body position is similar as in the SVV procedure. The subject had to place the chair in upright position again by placing the seating surface of the chair horizontal. The patient used his non-hemiplegic hand on the remote control. The clockwise rotation is shown positively and the counter clockwise rotation negatively.
- Conditions
- Sensory Disorder, Stroke, Cerebrovascular Disorders
- Being tested
- Observational clinical assessment
- Medical subject headings
- Sensation Disorders, Stroke, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational clinical assessmentBehavioural
perception of verticality measures SVV and SPV; somatosensory assessment RASP
What is being measured
The primary outcome is the main question the study is designed to answer.
Rivermead Assessment of Somatosensory Performance
This test assesses several modalities of somatosensory performance such as sharp/dull discrimination; warm/cold; proprioception; 2-point discrimination.
Measured: 1 day
Subjective Visual Vertical Test (SVV)
This test measures the ability of the subject to realign a laser bar with the earth vertical after the malalignment procedure. This test occurs in complete darkness to inhibit visual references. The device used for the projection is the Vertitest (Difra, Belgium).
Measured: 1 day
Subjective Postural Vertical Test
This test measures the ability of the subject to realign a chair, at which the subject is seated, with the earth vertical after a malalignment procedure. This test occurs blindfolded to inhibit visual references. The tilting chair used for this test is custom made. The deviation/error of the realigned chair compared to the earth vertical is measured by a digital protractor.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensory DisorderStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wim Saeys, Universiteit Antwerpen
- Investigators
- Wim Saeys, Dr, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019432
- Sponsor's protocol ID
- Saeys-2
- Status last verified
- Jan 2017
- First submitted
- 9 Jan 2017
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sensory Loss on the E-effect in Post-stroke Patients. A New Insight in Sensory Weighting Strategies
- ClinicalTrials.gov ID
- NCT03019432
- Acronym / sponsor ID
- Saeys-2
- Conditions
- Sensory Disorder, Stroke, Cerebrovascular Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 12 Jan 2017 (estimated)
- 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 study, the researchers will investigate whether the E-effect is present in stroke subjects both on the subjective visual and postural vertical test. In addition, researchers will investigate the impact of the loss of different sensory information sources on the sensory reweighting strategies and perception of verticality by measuring the effect of somatosensory loss on the E-effect.
Detailed description
Postural control emerges from the interaction between the task, the environment and the individual. Within the individual, an efficient interaction between motor, sensory and neural systems is needed in order to maintain postural control.(1) One of the neural processes is the integration of afferent information such as visual, vestibular and somatosensory input to construct a body-centred frame of reference in the gravitational environment.(2) This frame of reference must be vertically aligned with the gravitational vector to ensure axial extension of the body keeping the centre of gravity within the base of support.
Each of the sensory modalities has a relative load contribution in the estimation of verticality depending on the task and the environment.(3) In healthy subjects, when certain modalities are absent or information seems biased e.g. walking in complete darkness, more weight is given to other sensory input sources.(1) This reweighting of sensory information is therefore key in postural responses in humans.
However, sensory reweighting is not always adequate when certain modalities are biased. In verticality perception, when the roll tilt of the head is less than 60°-70°, a contralateral deviation of the subjective vertical has been reported.(4) This is called the E-effect and has been observed in both the Subjective Visual Vertical test (SVV) and the Subjective Postural Vertical test (SPV).(5, 6) Furthermore, studies have shown that also somatosensory loss has a negative impact on perceiving verticality in patients after stroke.(7) In our opinion, when less afferent input sources are present, adequate estimation of the earth vertical will be more difficult. Since, studies show that verticality perception is highly related to postural control(8, 9), this is of major importance. In neurological conditions such as stroke sensory input sources are often affected, leading to fewer options in sensory reweighting strategies.(10) In this study, the researchers will explore verticality perception and sensory reweighting strategies in stroke subjects. At first, the researchers will investigate whether the E-effect also occurs in our sample of stroke subjects. Secondly, they will investigate the effect of somatosensory loss on the extent of the E-effect. It can be hypothesized that when patients have no sensory loss, more secondary afferent input is available to improve estimation of the vertical and therefore less misleading by the head-on-body tilt.
Patients and methods Study design A cohort study was designed to investigate whether the E-effect occurs in people after stroke. In addition, the effect of somatosensory loss on the extent of the E-effect will be investigated to provide further insights in the sensory reweighting strategies. Ethical approval was given by the ethical committee with registration number B300201630358 in accordance with the Declaration of Helsinki 1975, revised Hong Kong 1989 Patients Patients were recruited from the stroke population of the rehabilitation hospital Revarte, Antwerp, Belgium. All patients with a history of first stroke attending a rehabilitation program were eligible for inclusion. Patients who had an age above 80; other neurological and orthopaedic impairments as well as brainstem, cerebellar or multiple lesions were excluded. Only strokes with an ischemic or hemorrhagic etiology were included. Patients were also excluded when the subjects had pre-existing co-morbid conditions that may affect vision and somatosensory function. In addition, patients with visuospatial neglect and pusher behaviour were also excluded as this can affect verticality perception. This was examined by a neuropsychologist and the use of the Scale of Contraversive Pushing (SCP)(11). In addition, patients had to perform the assessment within three months post-stroke. Prior to inclusion, the participants were asked whether they understand the instructions of tests and to sign a written informed consent.
Outcome measures Rivermead assessment for somatosensory Performance The Rivermead Assessment for Somatosensory Performance (RASP) measures different somatosensory modalities on the face, hands and feet and has been noted to be a reliable and standardized assessment. Six tests are administered on each of the ten (five left and five right) test regions on the face; hands and feet, two tests are administered on only the face and palm of the hands. During testing eyes of the participants are closed. These eight tests can be divided into six primary and two secondary tests of sensation. Six trials are executed on each of the ten test regions, for two of the tests sham trials were given. Sham trials increase the patient's internal reliability. Patients were excluded from the statistical analysis if they had more than five false positive replies, suggested by Winward et al.(12) Subjective Visual Vertical (SVV) The Difra Vertitest type D107201 (Difra, Welkenraedt, Belgium) was used for SVV assessment. The device has an accuracy of 0.1°. A laser bar is projected at a distance of 2.5m on an opposing wall and on an altitude of 1.5m. The patients are seated in front of the device on a chair without any arm- or backrests. Patients with no adequate sitting balance were assessed while seated in their wheelchair. The room was darkened and five minutes of waiting period was given allowing the subject to adjust the darkness. Both researcher and participant obtained a remote to allow rotating the laser bar either clockwise (right) or counter clockwise (left). The researcher's remote showed a display with the amount of deviation in relation to the earth's gravitational vector. The researcher made the laser bar invisible and rotated it in a specific angle in relation to the earth vertical. Subsequently, the line was shown after which the patient had to place the line in upright position again with his nonhemiplegic hand on the remote control. The amount of deviation of each starting roll position was different for each trial. A specified order was followed: first the line was placed in 20° counter clockwise, 10° clockwise, 5° counter clockwise and 0° according to the earth vertical, followed by 5° clockwise, 10° counter clockwise and finally 20° clockwise. This series was executed three times. During the first series the patient was asked to hold the head in normal upright position, followed by a series with the head tilted to the left (while the head was bent the subjects needed to keep their trunk upright) and finally a series with the head tilted to the right side. The clockwise rotation is shown positively and the counter clockwise negatively. The patients did not receive any feedback about their performance during assessment.
Subjective Postural Vertical (SPV) The rotation chair works on hydraulic pumps and has a height of 1m. On the back of the chair, a Mitutoyo digital protractor pro 3600 (Belgium) was mounted. This allowed measurement of the deviation in relation to the earth vertical with an accuracy of 0.01°. Both the researcher and patient were given a remote to rotate the chair clockwise (right) and counter clockwise (left). Movements were restricted in the frontal plane. Before the assessment started the patient was blindfolded, depriving the subjects of visual information when readjusting the chair to earth vertical. The researcher rotated the chair as in the procedure of SVV (starting roll position of the chair). The head-on-body position is similar as in the SVV procedure. The subject had to place the chair in upright position again by placing the seating surface of the chair horizontal. The patient used his non-hemiplegic hand on the remote control. The clockwise rotation is shown positively and the counter clockwise rotation negatively.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- stroke patients within 3 months poststroke hospitalized in a Belgian Rehabilitation Hospital
Key inclusion criteria (3 listed)
- Adult first-stroke patients
- Maximum 3 months post-stroke at inclusion
- Patients attending a rehabilitation program in the Rehabilitation Hospital Revarte, Belgium
Key exclusion criteria (5 listed)
- An age above 65
- Neurological, except stroke, and orthopaedic impairments influencing outcome measures
- Brainstem, cerebellar or multiple lesions
- An ischemic or hemorrhagic etiology
- Pre-existing co-morbid conditions that may affect vision and somatosensory function
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 |
|---|---|---|
| Observational clinical assessmentperception of verticality measures SVV and SPV; somatosensory assessment RASP | Behavioural | – |
Primary outcome
Rivermead Assessment of Somatosensory Performance
Time frame: 1 day
This test assesses several modalities of somatosensory performance such as sharp/dull discrimination; warm/cold; proprioception; 2-point discrimination.
Subjective Visual Vertical Test (SVV)
Time frame: 1 day
This test measures the ability of the subject to realign a laser bar with the earth vertical after the malalignment procedure. This test occurs in complete darkness to inhibit visual references. The device used for the projection is the Vertitest (Difra, Belgium).
Subjective Postural Vertical Test
Time frame: 1 day
This test measures the ability of the subject to realign a chair, at which the subject is seated, with the earth vertical after a malalignment procedure. This test occurs blindfolded to inhibit visual references. The tilting chair used for this test is custom made. The deviation/error of the realigned chair compared to the earth vertical is measured by a digital protractor.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Individual participant dataSharing planned: Undecided
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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.
Wim Saeys, Dr principal investigator
Universiteit Antwerpen
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 Sensory Disorder and Stroke, run by Universiteit Antwerpen at 1 site in Belgium.
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 3 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: status not confirmed, as of the sponsor's last update on 18 Jan 2017. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wim Saeys, Dr (0032496804347, wim.saeys@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rivermead Assessment of Somatosensory Performance (time frame: 1 day). The study lists 3 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 18 Jan 2017.