Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06301815
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-03-03
Brief Title:
Feasibility of Measuring Vertical Perception in Acute Stroke
Sponsor:
University of Winchester
Organization:
University of Winchester
Study Overview
Official Title:
Identifying Vertical Perception Loss in People With Acute Stroke A Feasibility Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed 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 eg through use of pictures or the skill of appropriate members of the clinical team eg 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 measuresThey 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 topicsquestions 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 15 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
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 eg through use of pictures or the skill of appropriate members of the clinical team eg 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 measuresThey 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 topicsquestions 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 15 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None