Hemispatial NeglectNCT05145855
The Effects of Offline Anosognosia For Spatial Neglect on Neglect Rehabilitation
An observational study of Hemispatial Neglect and Hemiplegia, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Anosognosia for hemispatial neglect is an intriguing phenomenon characterized by decreased awareness of spatial deficits, common in patients with right hemisphere stroke. However, it has not been examined as extensively as anosognosia for hemiplegia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemispatial Neglect, Hemiplegia, Right Hemispheric Stroke
- What is being tested?
- Patient-tailored multimodal neglect rehabilitation
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Nov 2021to 15 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with subacute or chronic right hemisphere injury who have hemispatial neglect.
Who may be able to join
- Being older than 18 years of age
- Having subacute or chronic right hemisphere injury
- Having left-sided hemispatial neglect based on Catherine Bergego Scale assessment.
Who cannot join
- Acute cerebral injury (within the first two weeks of disease),
- Bilateral cerebral lesions
- Other neurological and psychiatric disorders that prevent evaluation of HN (e.g., severe cognitive or primer visual impairment)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Hospital, Department of Physical Medicine and Rehabilitation
Ankara, 06560
About this study
Official title: Is Anosognosia for Hemispatial Neglect "a Barrier" or "an Opportunity" for Rehabilitation? A Retrospective Cohort Study.
Anosognosia for hemispatial neglect is an intriguing phenomenon characterized by decreased awareness of spatial deficits, common in patients with right hemisphere stroke. However, it has not been examined as extensively as anosognosia for hemiplegia. In this study, we aim to investigate the relationship between the decrease in anosognosia for neglect and the improvement of spatial deficits.
Read the detailed description
Babinski described the term "anosognosia" in 1914 as a phenomenon characterized by unawareness of the paralysis in patients with right hemisphere lesions. Now, this term is used for not only ignorance of hemiplegia but also unawareness of somatosensory, visual deficits, or cognitive disorders like aphasia and memory problems. Another phenomenon, hemispatial neglect (HN), is inattention and decreased responsiveness to the contralesional half of the space that cannot be attributed to the primary motor and sensory deficits. In this perspective, anosognosia for spatial neglect is an intriguing issue. Chen et al. have proposed two different domains of anosognosia for HN. Offline (general) anosognosia means the unawareness of spatial deficits based on daily living experiences. Online (task-specific) anosognosia refers to underestimating spatial errors that are likely to occur in an upcoming task or have just occurred during the task. In this study, we will investigate the relationship between HN and offline anosognosia for HN in right hemisphere injured patients. Besides, we aim to examine how the increased awareness of spatial problems in daily life could affect the success of HN rehabilitation.
This retrospective cohort study will be conducted based on the medical records of HN patients with right hemisphere injury hospitalized in our rehabilitation clinic between 2012 and 2019. Demographic data such as age, gender, weeks after disease onset, rehabilitation duration; and clinical data such as HN severity, extinction phenomena, anosognosia level, sensorimotor functions of the affected (left) extremities, functional ambulation, and independence in activities of daily living will be extracted from medical records. The severities of HN and anosognosia for HN will be determined based on the scores of the Catherine Bergego Scale (CBS) assessments. The cohort will be divided into groups as anosognosia-positive and anosognosia-negative regarding the anosognosia scores of patients. Baseline parameters will be compared between the two groups. A patient-specific neglect rehabilitation program comprising 30-45-minute sessions five times a week will be considered, having been routinely administered to all patients to be included in this cohort. Based on this assumption, clinical data recorded at discharge will be included in the final analysis regarding the effect of rehabilitation on HN.
- Conditions
- Hemispatial Neglect, Hemiplegia, Right Hemispheric Stroke, Anosognosia
- Being tested
- Patient-tailored multimodal neglect rehabilitation
- Keywords
- Anosognosia, Hemispatial neglect, Catherine Bergego Scale, Cognitive rehabilitation, Brain injury
- Medical subject headings
- Perceptual Disorders, Hemiplegia, Agnosia, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-tailored multimodal neglect rehabilitationOther
Patient-tailored neglect rehabilitation program which comprises 30-45 minutes of sessions, five times per week includes a combination of reading, copying, and representational drawing tasks with visual or verbal cueing, visual scanning, mirror therapy, and allocation of attention to the neglected side using multimodal stimulus in daily activities.
| Study group | Role | What they receive |
|---|---|---|
| Anosognosia-positive group | Patients will be included in the anosognosia-positive group if they achieved at least one positive anosognosia score before rehabilitation. The anosognosia score for HN will be calculated by subtracting the patient's self-evaluation score from the score assigned by the rehabilitation nurse using the parallel Catherine Bergego Scale. Receives: Other: Patient-tailored multimodal neglect rehabilitation | |
| Anosognosia-negative group | Patients will be included in the anosognosia-negative group if they achieved zero or negative anosognosia score before rehabilitation. Receives: Other: Patient-tailored multimodal neglect rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catherine Bergego Scale score before rehabilitation
Catherine Bergego Scale score, which was assigned before rehabilitation by an experienced rehabilitation nurse, will be obtained.
CBS is a 10-item questionnaire based on direct observation of the patient's activities of daily living such as grooming, dressing, eating, cleaning mouth after a meal, gaze orientation, left limb knowledge, auditory attention, collide when moving, spatial orientation and, finding belongings. For each item, a 4-point scale ranging from 0 (no ignore) to 3 (severe ignore) is used. The sum of scores of all items ranges from zero to 30. Higher scores represent more severe spatial neglect behavior.
Measured: Baseline (before rehabilitation)
Score of anosognosia for neglect before rehabilitation
Anosognosia score, which was calculated based on the Catherine Bergego Scale before rehabilitation, will be obtained.
Catherine Bergego Scale is a parallel test that can be applied to patients by themselves or by observers. The score of anosognosia for HN will be calculated by subtracting the patient's self-assessment score from the rehabilitation nurse's assessment score. Higher scores show more severe anosognosia for hemispatial neglect.
Measured: Baseline (before rehabilitation)
Catherine Bergego Scale score after rehabilitation
Catherine Bergego Scale score, which was assigned after rehabilitation by an experienced rehabilitation nurse, will be obtained.
CBS is a 10-item questionnaire based on direct observation of the patient's activities of daily living such as grooming, dressing, eating, cleaning mouth after a meal, gaze orientation, left limb knowledge, auditory attention, collide when moving, spatial orientation and, finding belongings. For each item, a 4-point scale ranging from 0 (no ignore) to 3 (severe ignore) is used. The sum of scores of all items ranges from zero to 30. Higher scores represent more severe spatial neglect behavior.
Measured: Immediately after the rehabilitation
Score of anosognosia for neglect after rehabilitation
Anosognosia score, which was calculated based on the Catherine Bergego Scale after rehabilitation, will be obtained.
Catherine Bergego Scale is a parallel test that can be applied to patients by themselves or by observers. The score of anosognosia for HN will be calculated by subtracting the patient's self-assessment score from the rehabilitation nurse's assessment score. Higher scores show more severe anosognosia for hemispatial neglect.
Measured: Immediately after the rehabilitation
Secondary outcomes (8)
Prevalence of the extinction on the visual double simultaneous stimulation test
Prevalence of the extinction on the visual double simultaneous stimulation (DSS) test will be obtained.
For visual DSS, the examiner stands in front of the patient's midline, raises both hands, and moves the index fingers (right, left, or both) while the patient was looking at the examiner's nose. The patient is asked to say or point which fingers (right, left, or both) were moving. After enough trials (at least 3 trials) presence of unilateral (non-neglected side) biased response to bilateral stimulation is considered a positive visual extinction phenomenon.
Measured: Baseline (before rehabilitation)
Prevalence of the extinction on the auditory double simultaneous stimulation test
Prevalence of the extinction on the auditory double simultaneous stimulation (DSS) test will be obtained. For auditory DSS, the examiner stands behind the patient and snaps her right, left, or both fingers near the participant's ears. The patient is asked to say or point which side (right, left, or both) the sound came from. After enough trials (at least 3 trials) presence of unilateral (non-neglected side) biased response to bilateral stimulation is considered a positive auditory extinction phenomenon.
Measured: Baseline (before rehabilitation)
Prevalence of the extinction on the tactile double simultaneous stimulation test
Prevalence of the extinction on the tactile double simultaneous stimulation (DSS) test will be obtained. For tactile DSS, the examiner sits behind the patient and touches the right shoulder, left shoulder, or both shoulders of the patient while the patient's eyes are closed. The patient is asked to say or point which side (right, left, or both) the assessor touched. After enough trials (at least 3 trials) presence of unilateral (non-neglected side) biased response to bilateral stimulation is considered a positive tactile extinction phenomenon.
Measured: Baseline (before rehabilitation)
Functional Ambulation Classification
Before rehabilitation, the level of the patients in the Functional Ambulation Classification will be obtained. The Functional Ambulation Classification (FAC) is a 6-point functional walking test that evaluates ambulation ability, determining how much human support the patient requires when walking, regardless of whether they use a personal assistive device. Higher stages show better mobility status.
Measured: Baseline (before rehabilitation)
Functional Independence Measurement
Before rehabilitation, the level of the patients in the Functional Independence Measurement will be obtained.
The Functional Independence Measure (FIM) is an assessment tool that aims to evaluate the functional status of patients in their daily activities throughout the rehabilitation process. FIM is comprised of 18 items, grouped into 2 subscales - motor and cognition. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The total FIM score ranges from 7 to 126. The higher the score, the more independent the patient is in performing the task associated with that item.
Measured: Baseline (before rehabilitation)
Brunnstrom stage of the hand
Brunnstrom stages are used to evaluate the sensorimotor functions and recovery status of stroke patients. It addresses the functions of the upper extremity, hand, and lower extremity separately based on 6 consecutive stages. Higher stages show better sensorimotor function after stroke.
Measured: Baseline (before rehabilitation)
Brunnstrom stage of the upper extremity
Brunnstrom stages are used to evaluate the sensorimotor functions and recovery status of stroke patients. It addresses the functions of the upper extremity, hand, and lower extremity separately based on 6 consecutive stages. Higher stages show better sensorimotor function after stroke.
Measured: Baseline (before rehabilitation)
Brunnstrom stage of the lower extremity
Brunnstrom stages are used to evaluate the sensorimotor functions and recovery status of stroke patients. It addresses the functions of the upper extremity, hand, and lower extremity separately based on 6 consecutive stages. Higher stages show better sensorimotor function after stroke.
Measured: Baseline (before rehabilitation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start29 Nov 2021
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hemispatial NeglectStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Levent Karataş, Gazi University
- Investigators
- Gülçin Kaymak Karataş, MD, Principal investigator, Gazi University Faculty of MedicineLevent Karataş, MD, Principal investigator, Gazi University Faculty of MedicineAyça Utkan Karasu, MD, Principal investigator, Gazi University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145855
- Sponsor's protocol ID
- Gazi FTR Anosognosi-İhmal
- Status last verified
- Nov 2022
- First submitted
- 11 Nov 2021
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Langer KG, Bogousslavsky J. The Merging Tracks of Anosognosia and Neglect. Eur Neurol. 2020;83(4):438-446. doi: 10.1159/000510397. Epub 2020 Sep 14.
PubMed 32927461Ronchi R, Bolognini N, Gallucci M, Chiapella L, Algeri L, Spada MS, Vallar G. (Un)awareness of unilateral spatial neglect: a quantitative evaluation of performance in visuo-spatial tasks. Cortex. 2014 Dec;61:167-82. doi: 10.1016/j.cortex.2014.10.004.
PubMed 25481474Chen P, Toglia J. Online and offline awareness deficits: Anosognosia for spatial neglect. Rehabil Psychol. 2019 Feb;64(1):50-64. doi: 10.1037/rep0000207. Epub 2018 Apr 12.
PubMed 29648845Toglia J, Chen P. Spatial exploration strategy training for spatial neglect: A pilot study. Neuropsychol Rehabil. 2022 Jun;32(5):792-813. doi: 10.1080/09602011.2020.1790394. Epub 2020 Jul 20.
PubMed 32684100Karatas L, Utkan Karasu A, Karatas GK. The effect of offline anosognosia for hemispatial neglect on neglect rehabilitation in patients with subacute and chronic right hemispheric brain injury. A retrospective cohort study. Neuropsychol Rehabil. 2024 Apr;34(3):453-468. doi: 10.1080/09602011.2023.2202862. Epub 2023 Apr 19.
PubMed 37073753
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Anosognosia for Hemispatial Neglect "a Barrier" or "an Opportunity" for Rehabilitation? A Retrospective Cohort Study.
- ClinicalTrials.gov ID
- NCT05145855
- Acronym / sponsor ID
- Gazi FTR Anosognosi-İhmal
- Conditions
- Hemispatial Neglect, Hemiplegia, Right Hemispheric Stroke, Anosognosia
- Keywords
- Anosognosia, Hemispatial neglect, Catherine Bergego Scale, Cognitive rehabilitation, Brain injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 6 Dec 2021 (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.
Anosognosia for hemispatial neglect is an intriguing phenomenon characterized by decreased awareness of spatial deficits, common in patients with right hemisphere stroke. However, it has not been examined as extensively as anosognosia for hemiplegia. In this study, we aim to investigate the relationship between the decrease in anosognosia for neglect and the improvement of spatial deficits.
Detailed description
Babinski described the term "anosognosia" in 1914 as a phenomenon characterized by unawareness of the paralysis in patients with right hemisphere lesions. Now, this term is used for not only ignorance of hemiplegia but also unawareness of somatosensory, visual deficits, or cognitive disorders like aphasia and memory problems. Another phenomenon, hemispatial neglect (HN), is inattention and decreased responsiveness to the contralesional half of the space that cannot be attributed to the primary motor and sensory deficits. In this perspective, anosognosia for spatial neglect is an intriguing issue. Chen et al. have proposed two different domains of anosognosia for HN. Offline (general) anosognosia means the unawareness of spatial deficits based on daily living experiences. Online (task-specific) anosognosia refers to underestimating spatial errors that are likely to occur in an upcoming task or have just occurred during the task. In this study, we will investigate the relationship between HN and offline anosognosia for HN in right hemisphere injured patients. Besides, we aim to examine how the increased awareness of spatial problems in daily life could affect the success of HN rehabilitation.
This retrospective cohort study will be conducted based on the medical records of HN patients with right hemisphere injury hospitalized in our rehabilitation clinic between 2012 and 2019. Demographic data such as age, gender, weeks after disease onset, rehabilitation duration; and clinical data such as HN severity, extinction phenomena, anosognosia level, sensorimotor functions of the affected (left) extremities, functional ambulation, and independence in activities of daily living will be extracted from medical records. The severities of HN and anosognosia for HN will be determined based on the scores of the Catherine Bergego Scale (CBS) assessments. The cohort will be divided into groups as anosognosia-positive and anosognosia-negative regarding the anosognosia scores of patients. Baseline parameters will be compared between the two groups. A patient-specific neglect rehabilitation program comprising 30-45-minute sessions five times a week will be considered, having been routinely administered to all patients to be included in this cohort. Based on this assumption, clinical data recorded at discharge will be included in the final analysis regarding the effect of rehabilitation on HN.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anosognosia-positive group | – | Other: Patient-tailored multimodal neglect rehabilitationPatients will be included in the anosognosia-positive group if they achieved at least one positive anosognosia score before rehabilitation. The anosognosia score for HN will be calculated by subtracting the patient's self-evaluation score from the score assigned by the rehabilitation nurse using the parallel Catherine Bergego Scale. |
| Anosognosia-negative group | – | Other: Patient-tailored multimodal neglect rehabilitationPatients will be included in the anosognosia-negative group if they achieved zero or negative anosognosia score before rehabilitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with subacute or chronic right hemisphere injury who have hemispatial neglect.
Key inclusion criteria (3 listed)
- Being older than 18 years of age
- Having subacute or chronic right hemisphere injury
- Having left-sided hemispatial neglect based on Catherine Bergego Scale assessment.
Key exclusion criteria (3 listed)
- Acute cerebral injury (within the first two weeks of disease),
- Bilateral cerebral lesions
- Other neurological and psychiatric disorders that prevent evaluation of HN (e.g., severe cognitive or primer visual impairment)
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 |
|---|---|---|
| Patient-tailored multimodal neglect rehabilitationPatient-tailored neglect rehabilitation program which comprises 30-45 minutes of sessions, five times per week includes a combination of reading, copying, and representational drawing tasks with visual or verbal cueing, visual scanning, mirror therapy, and allocation of attention to the neglected side using multimodal stimulus in daily activities. | Other | Anosognosia-negative group, Anosognosia-positive group |
Primary outcome
Catherine Bergego Scale score before rehabilitation
Time frame: Baseline (before rehabilitation)
Catherine Bergego Scale score, which was assigned before rehabilitation by an experienced rehabilitation nurse, will be obtained. CBS is a 10-item questionnaire based on direct observation of the patient's activities of daily living such as grooming, dressing, eating, cleaning mouth after a meal, gaze orientation, left limb knowledge, auditory attention, collide when moving, spatial orientation and, finding belongings. For each item, a 4-point scale ranging from 0 (no ignore) to 3 (severe ignore) is used. The sum of scores of all items ranges from zero to 30. Higher scores represent more severe spatial neglect behavior.
Score of anosognosia for neglect before rehabilitation
Time frame: Baseline (before rehabilitation)
Anosognosia score, which was calculated based on the Catherine Bergego Scale before rehabilitation, will be obtained. Catherine Bergego Scale is a parallel test that can be applied to patients by themselves or by observers. The score of anosognosia for HN will be calculated by subtracting the patient's self-assessment score from the rehabilitation nurse's assessment score. Higher scores show more severe anosognosia for hemispatial neglect.
Catherine Bergego Scale score after rehabilitation
Time frame: Immediately after the rehabilitation
Catherine Bergego Scale score, which was assigned after rehabilitation by an experienced rehabilitation nurse, will be obtained. CBS is a 10-item questionnaire based on direct observation of the patient's activities of daily living such as grooming, dressing, eating, cleaning mouth after a meal, gaze orientation, left limb knowledge, auditory attention, collide when moving, spatial orientation and, finding belongings. For each item, a 4-point scale ranging from 0 (no ignore) to 3 (severe ignore) is used. The sum of scores of all items ranges from zero to 30. Higher scores represent more severe spatial neglect behavior.
Score of anosognosia for neglect after rehabilitation
Time frame: Immediately after the rehabilitation
Anosognosia score, which was calculated based on the Catherine Bergego Scale after rehabilitation, will be obtained. Catherine Bergego Scale is a parallel test that can be applied to patients by themselves or by observers. The score of anosognosia for HN will be calculated by subtracting the patient's self-assessment score from the rehabilitation nurse's assessment score. Higher scores show more severe anosognosia for hemispatial neglect.
8 secondary outcomes
Prevalence of the extinction on the visual double simultaneous stimulation test
Time frame: Baseline (before rehabilitation)
Prevalence of the extinction on the auditory double simultaneous stimulation test
Time frame: Baseline (before rehabilitation)
Prevalence of the extinction on the tactile double simultaneous stimulation test
Time frame: Baseline (before rehabilitation)
Functional Ambulation Classification
Time frame: Baseline (before rehabilitation)
Functional Independence Measurement
Time frame: Baseline (before rehabilitation)
Brunnstrom stage of the hand
Time frame: Baseline (before rehabilitation)
Brunnstrom stage of the upper extremity
Time frame: Baseline (before rehabilitation)
Brunnstrom stage of the lower extremity
Time frame: Baseline (before rehabilitation)
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 2 Dec 2022.
- Background: PubMed 32927461Langer KG, Bogousslavsky J. The Merging Tracks of Anosognosia and Neglect. Eur Neurol. 2020;83(4):438-446. doi: 10.1159/000510397. Epub 2020 Sep 14.
- Background: PubMed 25481474Ronchi R, Bolognini N, Gallucci M, Chiapella L, Algeri L, Spada MS, Vallar G. (Un)awareness of unilateral spatial neglect: a quantitative evaluation of performance in visuo-spatial tasks. Cortex. 2014 Dec;61:167-82. doi: 10.1016/j.cortex.2014.10.004.
- Background: PubMed 29648845Chen P, Toglia J. Online and offline awareness deficits: Anosognosia for spatial neglect. Rehabil Psychol. 2019 Feb;64(1):50-64. doi: 10.1037/rep0000207. Epub 2018 Apr 12.
- Background: PubMed 32684100Toglia J, Chen P. Spatial exploration strategy training for spatial neglect: A pilot study. Neuropsychol Rehabil. 2022 Jun;32(5):792-813. doi: 10.1080/09602011.2020.1790394. Epub 2020 Jul 20.
- Derived from this study: PubMed 37073753Karatas L, Utkan Karasu A, Karatas GK. The effect of offline anosognosia for hemispatial neglect on neglect rehabilitation in patients with subacute and chronic right hemispheric brain injury. A retrospective cohort study. Neuropsychol Rehabil. 2024 Apr;34(3):453-468. doi: 10.1080/09602011.2023.2202862. Epub 2023 Apr 19.
- 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.
Gülçin Kaymak Karataş, MD principal investigator
Gazi University Faculty of Medicine
Levent Karataş, MD principal investigator
Gazi University Faculty of Medicine
Ayça Utkan Karasu, MD principal investigator
Gazi University Faculty of Medicine
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 Hemispatial Neglect and Hemiplegia, run by Gazi 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 3 inclusion and 3 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 2 Dec 2022. 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?
Catherine Bergego Scale score before rehabilitation (time frame: Baseline (before rehabilitation)). 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?
On the ClinicalTrials.gov record for NCT05145855, which also lists 5 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 2 Dec 2022.