NCT06301815

Brief Summary

The goal of this observational study is to establish if it is feasible to identify vertical perception deficits in people with acute stroke. The primary purpose to the study is: • To establish the feasibility of completing the Catherine Bergego Scale, Scale for Contraversive Pushing (SCP) and bucket test in a clinical environment with acute stroke patients to assist with identification of vertical perception loss. Participants will be asked to complete the assessments with a therapist 48 hours after admission. If they are not completed for any reason attempts will be made to complete them at one, two and four weeks after admission. Some participants will have them completed again on discharge. The Catherine Bergego Scale and SCP are observational and will involve a therapist watching the participant undertake daily activities. The bucket test involves a therapist placing a bucket in front of the face of the participant and asking them to identify when a line on the bottom of the bucket is vertical. Acceptabiliy and feasibility will be further investigated using a survey of participants who complete the assessments and through focus groups with the rehabilitation professionals admininstering the assessments. If it is feasible and acceptable to complete these assessments then further research can use them as an acceptable measure of vertical alignment in the clinical setting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2024

Completed
6 months until next milestone

Results Posted

Study results publicly available

June 8, 2025

Completed
Last Updated

June 8, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

March 3, 2024

Results QC Date

April 26, 2025

Last Update Submit

June 5, 2025

Conditions

Keywords

Vertical PerceptionRehabilitationNeglectPushing BehaviourSubjective Visual Vertical

Outcome Measures

Primary Outcomes (3)

  • Bucket Test to Measure Subjective Visual Vertical (SVV).

    The bucket test involves the patient being sat upright and looking into a translucent bucket. On the inside of the bucket on the bottom is a dark straight line. On the outside of the bottom of the bucket is a matching dark line, the bottom of the bucket is divided into degrees with the zero-degree line being equivalent to the line inside the bucket. For measurement the bucket will be randomly rotated right or left by the examiner to 45 degrees and then slowly rotated back to the zero-degree position. Patients will signal when they estimate the inside bottom line to be truly vertical by saying "stop" or by raising their non-paretic hand. Degrees will be read off on the outside scale by the examiner. The procedure will be repeated 6 times (3 to left and 3 to right) in a random order. A mean of the 6 tests will be calculated to be the tilt of SVV. The standard deviation (SD) of the mean of the 6 tests will be calculated to represent the uncertainty of SVV.

    Admission, 1 week, 2 weeks and 4 weeks, but not repeated once successfully completed.

  • Catherine Bergego Scale to Measure Neglect.

    Neglect will be assessed using the Catherine Bergego Scale. This established outcome measure for neglect is free and observational, it reflects existing practice and therefore reduces the burden on research participants. The scale is a 10-point scale with each item scored between 0 (no neglect) and 3 (severe neglect). Such as grooming, walking, eating and dressing. Minimum score is 0 - no neglect and maximum score is 30 - severe neglect

    Admission, 1 week, 2 weeks and 4 weeks, but not repeated once successfully completed.

  • Scale for Contraversive Pushing to Measure Lateropulsion

    Lateropulsion will be assessed using the Scale for Contraversive Pushing (SCP). This observational assessment can be conducted as part of routine therapy sessions. Scores are assessed in sitting and standing giving a maximum score of 6. The SCP has been found to be a reliable and valid measure. It involves observation of the posture of the patient in sitting and standing. Minimum score of 0 is no sign of lateropulsion and maximum score of 6 is severe lateropulsion.

    Admission, 1 week, 2 weeks and 4 weeks, but not repeated once succesfully completed.

Interventions

Lateropulsion will be assessed using the Scale for Contraversive Pushing (SCP). It involves observation of the posture of the participant in sitting and standing. Scores are assessed in sitting and standing giving a maximum score of 6.

Neglect will be assessed using the Catherine Bergego Scale. The scale is a 10-point scale with each item scored between 0 (no neglect) and 3 (severe neglect). It involves observation of a participant completing daily activities such as eating, dressing and walking.

Bucket TestDIAGNOSTIC_TEST

The bucket test involves the patient being sat upright and looking into a translucent bucket with the bucket covering their complete field of vision. On the inside of the bucket on the bottom is a dark straight line. On the outside of the bottom of the bucket is a matching dark line, the bottom of the bucket is divided into degrees with the zero-degree line being equivalent to the line inside the bucket. For measurement the bucket will be randomly rotated right or left by the examiner to 45 degrees and then slowly rotated back to the zero-degree position. Patients will signal when they estimate the inside bottom line to be truly vertical by saying "stop" or by raising their non-paretic hand.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Acute stroke patients in inpatient care

You may qualify if:

  • Diagnosis of first stroke by stroke consultant based on clinical or radiographical findings
  • Admitted to stroke unit with a length of stay of over 72 hours
  • Ability to consent or an advocate to consent on their behalf
  • Pre-morbid Modified Rankin Scale of less than 4

You may not qualify if:

  • Under the age of 18
  • Diagnosis of Transient Ischaemic Attack (TIA)
  • Previous diagnosis of stroke or other neurological diagnosis affecting the brain with residual impairment
  • Patients on an end of life pathway
  • Patients with pre-morbid visual impairment that will not allow them to see the bucket test. Glasses can be worn.
  • Inability to speak the English language and no interpreter can be found

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Hampshire County Hospital

Winchester, SO22 5DG, United Kingdom

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Limitations and Caveats

No known limitations or caveats

Results Point of Contact

Title
Amelia Shaw
Organization
University of Winchester

Study Officials

  • Prof James Faulkner, PhD

    University of Winchester

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2024

First Posted

March 8, 2024

Study Start

May 1, 2024

Primary Completion

October 31, 2024

Study Completion

December 3, 2024

Last Updated

June 8, 2025

Results First Posted

June 8, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations