Spatial Neglect After StrokeNCT01341574
Early Versus Delayed Treatment of Unilateral Neglect After Stroke
A study testing Prism adaptation with optical shift of 10 degrees. and Prism adaptation optical shift of 0 degrees. in people with Spatial Neglect After Stroke, run by University Ghent at 3 sites in Belgium.
Trial summary
'Unilateral neglect' is a disorder that occurs regularly after stroke. It is caused by right- as well as left-sided brain lesions, but more often by right-sided lesions. Patients with this disorder neglect the contralesional side of space and/or their body. Their body axis is often shifted ipsilesionally. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spatial Neglect After Stroke
- What is being tested?
- Prism adaptation with optical shift of 10 degrees. and Prism adaptation optical shift of 0 degrees.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 3 sitesBelgium
- Study dates
- Aug 2011to Dec 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female
- > 17 years of age
- stroke patients with clinical neglect, demonstrated by neglect tests
Who cannot join
- severe ocular abnormalities
- not being able to perform prism adaptation or neglect tests
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
Rehabilitation Hospital "Hof ter Schelde"
Antwerp
Ghent University Hospital, Center for Locomotor and Neurological Rehabilitation
Ghent
Ghent University Hospital, Department of Neurology
Ghent
About this study
Official title: Influence of Prism Adaptation on Spatial Neglect in the Early Versus Delayed Phase After Stroke: a Randomized, Placebo-controlled Trial
'Unilateral neglect' is a disorder that occurs regularly after stroke. It is caused by right- as well as left-sided brain lesions, but more often by right-sided lesions. Patients with this disorder neglect the contralesional side of space and/or their body. Their body axis is often shifted ipsilesionally. A specific disorder that can appear in neglect patients is 'contraversive pushing': a postural deviation to the neglected side because the patient pushes himself away from the ipsi- to the contralesional side.
One of the most promising neglect interventions is prism adaptation (PA): inducing an optical shift of the visual field by means of prism glasses. This results in a modulation of brain areas involved in neglect and in an improvement of the neglect symptoms and postural deviation.
Read more
Research questions:
- Which period is best suited to maximize therapeutic effects? In this respect the effects of early and delayed PA will be compared, regarding neglect-, postural and cerebral measures.
- Which factors lead to a less favorable treatment outcome or to therapy resistance for PA?
- Will the impact of PA be larger if postural factors are taken into account in the prism therapy?
- Conditions
- Spatial Neglect After Stroke
- Being tested
- Prism adaptation with optical shift of 10 degrees., Prism adaptation optical shift of 0 degrees.
- Keywords
- spatial neglect, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prism adaptation with optical shift of 10 degrees.Procedure or surgery
Prism adaptation with optical shift of 10 degrees.
Prism adaptation optical shift of 0 degrees.Procedure or surgery
Prism adaptation with optical shift of 0 degrees.
| Study group | Role | What they receive |
|---|---|---|
| Early phase, experimental | Experimental | Neglect patients, randomized in the experimental group (Prism adaptation, optical shift of 10 degrees) in the early phase after stroke. Receives: Procedure: Prism adaptation with optical shift of 10 degrees. |
| Delayed phase, experimental | Experimental | Neglect patients, randomized in the experimental group (Prism adaptation, optical shift of 10 degrees) in the delayed phase after stroke. Receives: Procedure: Prism adaptation with optical shift of 10 degrees. |
| Early phase, placebo | Placebo comparator | Neglect patients, randomized in the placebo group (Prism adaptation, optical shift of 0 degrees) in the early phase after stroke. Receives: Procedure: Prism adaptation optical shift of 0 degrees. |
| Delayed phase, placebo | Placebo comparator | Neglect patients, randomized in the placebo group (Prism adaptation, optical shift of 0 degrees) in the delayed phase after stroke. Receives: Procedure: Prism adaptation optical shift of 0 degrees. |
| Delayed phase postural, experimental | Experimental | Neglect patients, randomized in the experimental group (Prism adaptation, optical shift of 10 degrees) in the delayed phase after stroke. In this group, postural aspects are taken into account. Receives: Procedure: Prism adaptation with optical shift of 10 degrees. |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of prism adaptation
The effect of Prism Adaptation (PA) will be evaluated regarding the degree of neglect, postural control and cerebral functioning, briefly after the therapy cycle and 3 months later. Briefly after the PA sessions and three months later, in patients in the early as well as the delayed phase after stroke:
- early: PA starting within 4 weeks after stroke;
- delayed: PA starting 2 months after stroke;
- OR divided in an early and a delayed group according to the median.
Measured: Briefly after and 3 months after therapy cycle.
Secondary outcomes (1)
The degree of well-being.
Questionnaires about emotional and functional status.
Briefly after the Prism Adaptation (PA) sessions and 3 months later, in patients in the early as well as the delayed phase after stroke:
- early: PA starting within 4 weeks after stroke;
- delayed: PA starting 2 months after stroke;
- OR divided in an early and a delayed group according to the median.
Measured: Briefly after and 3 months after therapy cycle.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spatial Neglect After StrokeStudies of the same condition, open and under way.
- More trials run by University GhentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Responsible party
- Sponsor
- Investigators
- Guy Vingerhoets, Ph.D., Professor, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341574
- Sponsor's protocol ID
- 2011/161
- Other IDs
- G.0906.10
- Status last verified
- Nov 2021
- First submitted
- 18 Apr 2011
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Prism Adaptation on Spatial Neglect in the Early Versus Delayed Phase After Stroke: a Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01341574
- Acronym / sponsor ID
- 2011/161
- Conditions
- Spatial Neglect After Stroke
- Keywords
- spatial neglect, stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Study start
- Aug 2011 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Apr 2011 (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.
'Unilateral neglect' is a disorder that occurs regularly after stroke. It is caused by right- as well as left-sided brain lesions, but more often by right-sided lesions. Patients with this disorder neglect the contralesional side of space and/or their body. Their body axis is often shifted ipsilesionally. A specific disorder that can appear in neglect patients is 'contraversive pushing': a postural deviation to the neglected side because the patient pushes himself away from the ipsi- to the contralesional side.
One of the most promising neglect interventions is prism adaptation (PA): inducing an optical shift of the visual field by means of prism glasses. This results in a modulation of brain areas involved in neglect and in an improvement of the neglect symptoms and postural deviation.
Research questions:
- Which period is best suited to maximize therapeutic effects? In this respect the effects of early and delayed PA will be compared, regarding neglect-, postural and cerebral measures.
- Which factors lead to a less favorable treatment outcome or to therapy resistance for PA?
- Will the impact of PA be larger if postural factors are taken into account in the prism therapy?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Early phase, experimental | Experimental | Procedure: Prism adaptation with optical shift of 10 degrees.Neglect patients, randomized in the experimental group (Prism adaptation, optical shift of 10 degrees) in the early phase after stroke. |
| Delayed phase, experimental | Experimental | Procedure: Prism adaptation with optical shift of 10 degrees.Neglect patients, randomized in the experimental group (Prism adaptation, optical shift of 10 degrees) in the delayed phase after stroke. |
| Early phase, placebo | Placebo comparator | Procedure: Prism adaptation optical shift of 0 degrees.Neglect patients, randomized in the placebo group (Prism adaptation, optical shift of 0 degrees) in the early phase after stroke. |
| Delayed phase, placebo | Placebo comparator | Procedure: Prism adaptation optical shift of 0 degrees.Neglect patients, randomized in the placebo group (Prism adaptation, optical shift of 0 degrees) in the delayed phase after stroke. |
| Delayed phase postural, experimental | Experimental | Procedure: Prism adaptation with optical shift of 10 degrees.Neglect patients, randomized in the experimental group (Prism adaptation, optical shift of 10 degrees) in the delayed phase after stroke. In this group, postural aspects are taken into account. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male or female
- > 17 years of age
- stroke patients with clinical neglect, demonstrated by neglect tests
Key exclusion criteria (2 listed)
- severe ocular abnormalities
- not being able to perform prism adaptation or neglect tests
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 |
|---|---|---|
| Prism adaptation with optical shift of 10 degrees.Prism adaptation with optical shift of 10 degrees. | Procedure or surgery | Delayed phase postural, experimental, Delayed phase, experimental, Early phase, experimental |
| Prism adaptation optical shift of 0 degrees.Prism adaptation with optical shift of 0 degrees. | Procedure or surgery | Delayed phase, placebo, Early phase, placebo |
Primary outcome
effect of prism adaptation
Time frame: Briefly after and 3 months after therapy cycle.
The effect of Prism Adaptation (PA) will be evaluated regarding the degree of neglect, postural control and cerebral functioning, briefly after the therapy cycle and 3 months later. Briefly after the PA sessions and three months later, in patients in the early as well as the delayed phase after stroke: * early: PA starting within 4 weeks after stroke; * delayed: PA starting 2 months after stroke; * OR divided in an early and a delayed group according to the median.
1 secondary outcome
The degree of well-being.
Time frame: Briefly after and 3 months after therapy cycle.
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 19 Nov 2021.
Related trials for Spatial Neglect After Stroke
Recruiting
Prism Adaptation Therapy (PAT) for Right Brain Stroke Rehabilitation
Spatial Neglect After Right Brain Stroke
Not yet recruitingObservational study
Validation of Web-Based Star Cancellation and Line Bisection Tests in Hemiplegic Stroke
Stroke, Spatial Neglect
Recruiting
Comparing Prism Adaptation Training With and Without TENS to Minimize Unilateral Spatial Neglect
Unilateral Spatial Neglect, Stroke
Active, not recruitingObservational study
A Biomarker for Personalized Care in Post-Stroke Spatial Neglect
Spatial Neglect, Stroke
Not yet recruitingObservational study
Tridimensional Robotic Assessment of Neglect in Brain Injured Patients
Neglect, Brain Injured Patients
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.
Guy Vingerhoets, Ph.D., Professor principal investigator
University Ghent
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prism adaptation with optical shift of 10 degrees. and Prism adaptation optical shift of 0 degrees. in people with Spatial Neglect After Stroke, run by University Ghent at 3 sites 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 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 19 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 3 sites 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. Some participants in this study may receive a placebo. 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?
effect of prism adaptation (time frame: Briefly after and 3 months after therapy cycle.). 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 19 Nov 2021.