Trial Outcomes & Findings for Feasibility of Measuring Vertical Perception in Acute Stroke (NCT NCT06301815)
NCT ID: NCT06301815
Last Updated: 2025-06-08
Results Overview
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.
COMPLETED
53 participants
Admission, 1 week, 2 weeks and 4 weeks, but not repeated once successfully completed.
2025-06-08
Participant Flow
Participants were recruited between 1/5/2024 and 31/10/2024 on the acute stroke unit at Hampshire Hospitals NHS Foundation Trust, UK.
No significant Events
Participant milestones
| Measure |
Intervention Group
Participants who underwent the interventions as laid out in the protocol. As this was an observational study all participants underwent three assessments (bucket test, Catherine Bergego Scale and Scale for contraversive pushing) once on recruitment. There was only one group. These assessments were completed as soon as possible after admission to an acute stroke unit and were all completed by four weeks.
|
|---|---|
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Overall Study
STARTED
|
53
|
|
Overall Study
COMPLETED
|
53
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention Group
n=53 Participants
Participants who underwent the interventions as laid out in the protocol
|
|---|---|
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Age, Continuous
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77 Years
n=53 Participants
|
|
Sex: Female, Male
Female
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28 Participants
n=53 Participants
|
|
Sex: Female, Male
Male
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25 Participants
n=53 Participants
|
PRIMARY outcome
Timeframe: Admission, 1 week, 2 weeks and 4 weeks, but not repeated once successfully completed.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.
Outcome measures
| Measure |
Intervention Group
n=53 Participants
Participants who underwent the interventions as laid out in the protocol
|
|---|---|
|
Bucket Test to Measure Subjective Visual Vertical (SVV).
|
3.2 Degrees
Standard Deviation 3.6
|
PRIMARY outcome
Timeframe: Admission, 1 week, 2 weeks and 4 weeks, but not repeated once successfully completed.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
Outcome measures
| Measure |
Intervention Group
n=53 Participants
Participants who underwent the interventions as laid out in the protocol
|
|---|---|
|
Catherine Bergego Scale to Measure Neglect.
|
0 Units on a scale (0-30)
Interval 0.0 to 1.0
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PRIMARY outcome
Timeframe: Admission, 1 week, 2 weeks and 4 weeks, but not repeated once succesfully completed.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.
Outcome measures
| Measure |
Intervention Group
n=53 Participants
Participants who underwent the interventions as laid out in the protocol
|
|---|---|
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Scale for Contraversive Pushing to Measure Lateropulsion
|
0 Units on a scale (0-6)
Interval 0.0 to 1.0
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Adverse Events
Intervention Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place