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A feasibility study for attention loss after stroke

A feasibility Study of Prisms And Therapy In Attention Loss after stroke (SPATIAL feasibility)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN88395268
Enrollment
142
Registered
2019-01-09
Start date
2019-02-01
Completion date
Unknown
Last updated
2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention loss following stroke Nervous System Diseases Stroke, not specified as haemorrhage or infarction

Interventions

Current Interventions as of 10/02/2020: The trialists are testing how sensible and practical it is to use PAT as part of an occupational therapy session in order to inform a larger tri

Sponsors

The University of Manchester
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Current participant inclusion criteria as of 10/02/2020: PATIENT PARTICIPANTS 1. Over 18 years old 2. Confirmed stroke (ischaemic or hemorrhagic) 3. Positive for spatial inattention at routine screening 4. Spatial inattention impacting on functional task performance 5. At least 1 week post-stroke onset 6. Eligible for standard occupational therapy (for at least one session) 7. Able to provide informed consent (or availability of personal/ professional consultee) 8. Able to sit with support and perform brief research intervention (e.g. has sufficient vision, physical mobility and cognition to be able to participate) CARER PARTICIPANTS 1. Informal carer of a patient in the trial 2. Aged 18 or over 3. Able to provide informed consent STAFF PARTICIPANTS 1. A member of the NHS occupational therapy team (Occupational therapist, Occupational therapy assistant, rehabilitation assistant) 2. Has been trained in the study processes 3. The staff member has treated a minimum of 1 patient participant from the intervention arm Previous participant inclusion criteria: PATIENT PARTICIPANTS 1. Over 18 years old 2. Confirmed stroke (ischaemic or haemorrhagic) 3. Positive for spatial inattention at routine screening 4. Spatial inattention impacting on functional task performance 5. 1 to 4 weeks post stroke onset 6. Eligible for standard occupational therapy (for at least one session) 7. Able to provide informed consent (or availability of personal/ professional consultee) 8. Able to sit with support and perform brief research intervention (e.g. has sufficient vision, physical mobility to be able to participate) CARER PARTICIPANTS 1. Informal carer of a patient in the trial 2. Aged 18 or over 3. Able to provide informed consent STAFF PARTICIPANTS 1. A member of the NHS occupational therapy team (Occupational therapist, Occupational therapy assistant, rehabilitation assistant) 2. Has been trained in the study processes 3. The staff member has treated a minimum of 1 patient participant from the intervention arm

Exclusion criteria

Exclusion criteria: PATIENT PARTICIPANTS 1. Receiving or expected to receive end of life care 2. Discharge anticipated before at least one therapy session The trialists will begin this feasibility trial with broad inclusion criteria but will monitor and adjust these as recruitment proceeds. For example they will note levels of pre-stroke dependency using the modified Rankin Scale (mRS). They will initially include people regardless of their mRS, including those who were assessed as pre-morbidly dependent ie > 3 on the mRS (an mRS of 4 is defined as: moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance). A mRS of > 3 would only be added as an exclusion criterion should staff feedback and review of patient participation indicate that the intervention appears unsuitable for this group of patients. CARER PARTICIPANTS Under 18 STAFF PARTICIPANTS Have not provided PAT to any patient participants

Design outcomes

Primary

MeasureTime frame
Functional ability is measured using EADL at 12 weeks

Secondary

MeasureTime frame
1. Inattention is measured using star cancellation, Oxford Cognitive Screen, reading test and KF-NAP at baseline, 3 and 12 weeks 2. Impact of cognitive problems is measured using PRECiS at 12 weeks 3. Health status is measured using EQ5D5L at 12 weeks 4. Impact on carers is measured with the Carer Experience Scale, modified Carer Strain Index and self-reported informal carer costs at 12 weeks

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026