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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06951659




Registration number
NCT06951659
Ethics application status
Date submitted
13/04/2025
Date registered
30/04/2025
Date last updated
19/06/2025

Titles & IDs
Public title
Investigating Visual Verticality Disorder and Lateropulsion in a Neurosurgical Cohort of Patients With Brain Tumours
Scientific title
Clinical, Rehabilitation and Neuroimaging Investigation of Lateropulsion, Graviceptive Neglect and Verticality Perception in Neurosurgical Patients With Brain Tumours: A Prospective Cohort Study
Secondary ID [1] 0 0
RGS5125
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Tumours 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with a brain tumour. - This study will investigate a neurosurgical cohort of patients pre and post-brain tumour resection.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Visual Verticality Perception (VV, visual graviceptive neglect)
Assessment method [1] 0 0
Change in VV: assessment using the bucket test method.
Timepoint [1] 0 0
Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)
Primary outcome [2] 0 0
Subjective Haptic Vertical (SHV) test
Assessment method [2] 0 0
The SHV test, the participant is blindfolded and asked to align a movable rod or bar to what they perceive as vertical using only their sense of touch (haptic input). This is to isolate somatosensory and vestibular input from visual cues. This will be performed in an upright sitting position to explore graviceptive function and verticality perception.
Timepoint [2] 0 0
Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)
Primary outcome [3] 0 0
The Four Point Pusher's Score (4PPS)
Assessment method [3] 0 0
The 4PPS is a four-item scale that measures lateropulsion or pusher syndrome. The score for each component is rated on a scale from 0 to 3 (0 to 4 for standing) and the score is based on the severity of resistance or the tilt angle when the patient begins to resist the passive movement. The score for diagnosis of Pusher behaviour is \>2 points.
Timepoint [3] 0 0
Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)
Primary outcome [4] 0 0
Scale for Contraversive Pushing
Assessment method [4] 0 0
A 3-item scale that measures lateropulsion or pusher syndrome, by rating the action / reaction of patients required to keep or change position. Scores: 0= no contraversive pushing 1. minimum score for each item 2. maximum score Score on each component \>1 indicative of lateropulsion.
Timepoint [4] 0 0
Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)
Primary outcome [5] 0 0
Resource Utilisation Group Activities of Daily Living (RUG ADL)
Assessment method [5] 0 0
The RUG-ADL score is a 4-item scale measuring motor function with activities of bed mobility, toileting, transfer and eating. The score measures the degree of assistance a patient requires for these activities. The total RUG-ADL score is calculated by summing the scores for the four ADL variables. The total RUG-ADL score ranges from a minimum score of 4 to a maximum score of 18. The higher the score the more assistance the patient requires to complete the four ADL variables.
Timepoint [5] 0 0
Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)

Eligibility
Key inclusion criteria
* Patients of age 18 to 80 admitted to SCGH under the neurosurgery team with a confirmed diagnosis of a brain tumour.
* Only patients who undergo partial or full brain tumour resection and are medically stable.
* Able to provide written informed consent or consent provided by a Research Decision-Maker with the approval of an Independent Medical Practitioner (IMP) as per the Guardianship and Administration Act 1990 (GAA).
* Patients with a support network that enables them to accommodate to travel commitments for assessments if travel to the hospital is required.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients who undergo only biopsy will not be included.
* Unable to follow any instructions and complete assessments due to significant medical deterioration.
* Patients who are pregnant.
* Current diagnosis of COVID-19 or respiratory syncytial virus (RSV), or any type of influenza.
* Patients without a support network that enables them to accommodate to travel commitments for assessments if travel to the hospital is required.
* An Advanced Care Health Directive prohibiting decision making by Research Decision-Maker.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/06/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Sir Charles Gairdner Osborne Park Health Care Group - Perth
Recruitment postcode(s) [1] 0 0
6009 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Western Australia
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Sir Charles Gairdner Hospital
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Sao Paulo
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Taiza GS Edwards, PhD
Address 0 0
The University of Western Australia
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jimena Garcia-Vega, MSc
Address 0 0
Country 0 0
Phone 0 0
+61 434864334
Email 0 0
jimena.garcia-vega@research.uwa.edu.au
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06951659