Feasibility of Measuring Vertical Perception in Acute Stroke

Stroke Clinical Trial

Official title:

Identifying Vertical Perception Loss in People With Acute Stroke: A Feasibility Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06301815
• Other study ID #: Shaw_Stroke_REC24/YH/0010_2024
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: University of Winchester
• Contact: Amelia Shaw
• Phone: +441962841515
• Email: a.shaw2.18[@]unimail.winchester.ac.uk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

The secondary research questions that this study will aim to address are:

• What percentage of patients admitted to an acute stroke unit show a positive test for vertical perception loss within four weeks of admission (evidence of subjective visual vertical (SVV) tilt on either bucket test or Catherine Bergego Scale or evidence of subjective postural vertical (SPV) tilt on SCP)?

• For those able to complete the assessments, does vertical perception loss show any relationship with:

• Discharge (DC) destination

• Care package size on discharge

• Number of inpatient falls

• Level of functional independence on discharge

• Is there a trend for any element of the SCP or the Catherine Bergego to be more correlated with SVV tilt.

Primary outcomes:

The primary outcome is to understand the feasibility of completing the suite of outcome measures in an acute stroke setting. The study will determine the :

• Proportion (%) of patients on whom the assessments are attempted.

• Percentage of patients who are able to complete all three assessments within four weeks of admission.

• Time taken to complete the three measures in an acute clinical setting

• A recommendation regarding the most feasible time point to complete these assessments.

Secondary outputs:

The secondary aims are to gain a further understanding of vertical perception loss in acute stroke patients.

• An understanding of factors that prevent or facilitate completion of these three assessments

• An understanding of healthcare professionals' experiences of completing these assessments in an acute stroke unit.

• An understanding of whether people with stroke (or their advocates) find it appropriate to complete all three assessments in an acute stroke setting.

• Percentage of patients admitted to an acute stroke unit showing a positive test for vertical perception loss within four weeks of admission.

• To explore the relationship between vertical perception loss and:

• Discharge destination

• Care package size on discharge

• Number of inpatient falls

• Level of functional independence on discharge

• To explore if any elements of the Catherine Bergego Scale or Scale for Contraversive Pushing show a trend for a relationship to vertical perception loss Trial Setting The population to be studied will be acute stroke patients admitted to a stroke unit. A non-probability, convenience sample will be used. All patients with a diagnosis of stroke admitted for 72 hours to a single stroke unit at Royal Hampshire County Hospital will be considered in the present study. All those admitted to the stroke unit over a six-month period will be eligible for inclusion, meaning approximately 250 people will be screened for participation.

Recruitment Potential participants will be identified during the daily handover. Those meeting the inclusion criteria will be approached and invited to participate. This will take place between 48 hours and one week after admission. Potential participants will be provided with the participant information sheet (PIS). If the patient is unable to consent due to cognitive or language impairment or low level of consciousness then their advocate will be approached. Where possible potential participants will be supported to consent using information in different formats (e.g. through use of pictures) or the skill of appropriate members of the clinical team (e.g. speech and language therapists).

If a participant who lacked capacity, and was consented by an advocate, regains capacity then their informed consent to continue will be sought.

Study protocol For those patients who consent, the qualified physiotherapists or occupational therapists on the stroke unit, will then attempt to complete all 3 outcome measures with the patient. If the patient is unable to complete any elements of the outcome measure for any reason, this will be recorded. If the patient is unable to complete the outcome measures, then an attempt will be made to complete the outcome measures at 1 week post admission, if still unable they will be attempted again at 2 weeks and 4 weeks post admission. At the point participants complete all 3 outcome measures or at 4 weeks (whichever is earliest) most will have no further active participation in the quantitative part of the study. The assessments do not need to all be completed in one sitting and can be spread across sessions. If a patient is unable to be consented at 48 hours they will be consented as soon after this point as possible up to one week after admission, and this will be recorded. If patients are discharged or have a change in status following consenting to participate but prior to completion of the outcome measures any data collected to date will be utilised in the study results and the reasons for non-completion of the outcome measures will be noted as this will inform the feasibility of these outcome measures. The length of time taken to complete the measures will be recorded by the administrator. The expectation is that administration of all three outcome measures will take no longer than one hour. Due to the observational nature of the SCP and Catherine Bergego Scale elements of these can be completed during therapy sessions.

At the point the participants are discharged from the stroke unit appropriate information will be extracted from their medical records.

At the time of discharge a small sub-selection of the study participants will have the outcome measures reassessed. Participants will be identified as having a mild, moderate or severe vertical perception loss in order to allow a spectrum of loss to be measured during inpatient stay. Once discharged from the stroke unit participants will have no further input into the study.

Assessors Outcome measures will be undertaken by a qualified member of the therapy team on the stroke unit. This includes physiotherapists and occupational therapists. All those undertaking the outcome measures will be trained on their use by the main author (AS) to ensure consistency of approach.

Additional Research Activities. Focus Groups Prior to the study commencing a focus group will be completed with the therapists undertaking the outcome measures. This will be held following training on the outcome measures. Therapists will be invited to attend by AS at the end of the training session and provided with a PIS.

This will allow exploration of how feasible or acceptable the therapists feel it will be to complete the outcome measures before data collection. This can then be compared with their thoughts, and the thoughts of people with stroke and their advocates, on acceptability following use of the outcome measures.

At the six month point of the study the focus group will be repeated, with approximately 10 therapists, to allow exploration of the experiences of the therapists that undertook the outcome measures. This will allow collection of data from multiple participants using an unstructured but guided discussion of the use of the outcome measures in the acute stroke setting.

Potential participants will be members of the therapy team on the stroke unit who have undertaken the outcome measures.They will be provided with a PIS explaining the post-trial focus groups and the time and date at which the group will be undertaken. They can then decide if they wish to participate or not.

If they wish to participate they will be asked to sign a consent form and attend the group at the dedicated time. The groups will be moderated by the lead researcher (AS) using a list of topics/questions to guide the conversation. A second member of the research team, unknown to the participants, will assist in the groups to ensure smooth running of the groups and mitigate for the fact that AS will be known to many participants. Face to face groups will be held in the hospital setting at a time convenient to a majority of participants. The focus groups will last no longer than 1.5 hours. Ground rules will be introduced at the beginning of the groups to allow smooth running of the group and to put participants at ease. Focus groups will be recorded for transcription on MS Teams and stored behind two factor authentication on a password protected computer. Each group member will be assigned a participant number to assist with data analysis. The focus group will be anonymised and transcribed verbatim and following transcription the original recording will be deleted. At this point participants will no longer be able to withdraw from the study.

Patient Participant Feedback At the point they complete all the outcome measures (or at 4 weeks if they are unable to complete the measures) participants (or their advocates) will be asked to complete a short survey asking about the acceptability of the outcome measures. Questions will ask about their attitude towards, understanding of and burden of completing the outcome measures. It will be a mix of choice and Likert scale questions with some free text open questions. The survey should take no more than 15 mins to complete. Participants can be supported to complete the survey by an advocate, therapist or member of the research team who can read out the questions and record their responses, but will not influence the answers. The survey will be on paper for ease of completion in the clinical setting.

The decision as to whether it is feasible to use these outcome measures to identify those with vertical perception loss will be made on the basis of collated results of this trial.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Stroke

Intervention

Diagnostic Test:
• Scale for Contraversive Pushing
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.
• Catherine Bergego Scale
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 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.

Locations

Country	Name	City	State
United Kingdom	Royal Hampshire County Hospital	Winchester

Sponsors (3)

Lead Sponsor	Collaborator
University of Winchester	Hampshire Hospitals NHS Foundation Trust, University Hospitals Dorset NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.