Feasibility of a Neuropsychologically Informed Occupational Therapy Intervention Targeting Decreased Ability to Perform Activities of Daily Living in People With Poststroke Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 8
- 主要终点
- Change from baseline in ADL process skills level (assessed by the Assessment of Motor and Process Skills, AMPS) at 3 months poststroke
研究概览
简要总结
The purpose of this study is to investigate feasibility aspects of an intervention targeting problems in managing daily tasks due to mild-to-moderate poststroke cognitive impairments. We will specifically address uncertainties related to intervention content and delivery, and trial design and conduct.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria:
- •first-ever symptomatic stroke,
- •age ≥ 18 years,
- •residence in Frederiksberg Municipality, Denmark,
- •independent in pre-stroke everyday life (≤ 2 points on the modified Rankin Scale, mRS),
- •experiencing problems in performing ADLs due to cognitive impairment; these problems are expected to still be present at hospital discharge,
- •medical condition allows commencement of rehabilitation focused on ADL and cognition
- •fully aware or mild-to-moderate unawareness of deficits (≤ 2 points on the Bisiach Anosognosia Scale, BAS),
- •a global cognitive function corresponding to ≥ 17 points on the Montreal Cognitive Assessment, MoCA,
- •≤ 10 points on the depression subscale of the Hospital Anxiety and Depression Scale, HADS,
- •able to provide informed consent, as evaluated by the recruiting healthcare professional(s),
- •logistically possible to perform baseline assessments and create an individualised intervention plan during hospital stay
- •provides informed consent
排除标准
- •psychiatric conditions causing difficulties or preventing participation, as evaluated by the recruiting health care professional(s)
- •communication problems causing difficulties or preventing participation, as evaluated by the recruiting healthcare professional(s)
- •CAREGIVERS:
- •Inclusion criteria:
- •appointed as close carer (by a patient who consented to participate),
- •age ≥18y,
- •provides informed consent.
- •Exclusion criteria:
- •communication problems or other issues causing difficulties in participation as evaluated by the recruiting healthcare professional(s).
- •Patients without a close carer will not be excluded.
- •CLINICAL STAFF:
- •Inclusion criteria:
- •appointed as local project managers, or OTs or NPs who conduct assessments or deliver the intervention in the participating centres,
- •provides informed consent.
- •Exclusion criteria:
- •- unable to to follow a preliminary English version of the intervention manual.
结局指标
主要结局
Change from baseline in ADL process skills level (assessed by the Assessment of Motor and Process Skills, AMPS) at 3 months poststroke
时间窗: At baseline (as soon as possible after stroke onset - expected:1 week poststroke) and 3 months poststroke
The AMPS is a standardised observation-based instrument measuring two aspects of ADL performance: ADL motor skills (reflecting physical effort) and ADL process skills (reflecting efficiency, safety, and independence). The quality of each skill is evaluated on a 4-level scale. Based on Rasch statistics, the AMPS software converts these raw scores into two overall linear ADL scores (expressed in logits): an ADL motor score, and an ADL process score. Several studies support the AMPS' validity and reliability in both stroke populations. The AMPS is an OT-specific instrument and requires user certification.
次要结局
- Change from pre-stroke in global disability (assessed by the modified Rankin Scale, mRS) at 3 months. Min-max values: 0 (no symptoms at all) - 6 (dead)(At baseline (as soon as possible after stroke onset - expected:1 week poststroke) and 3 months poststroke)
- Caregiver perceived burden of stroke (assessed by the Caregiver Burden Scale, CBS) at 3 months posttsroke.(At 3 months poststroke)
- Change from baseline in ADL motor skills level (assessed by the Assessment of Motor and Process Skills, AMPS) at 3 months poststroke(At baseline (as soon as possible after stroke onset - expected:1 week poststroke) and 3 months poststroke)
- Patient perceived health-related quality of life (assessed by the EuroQol-5D-5L, EQ-5D-5L) at 3 months poststroke(At 3 months poststroke)
研究者
Emma Ghaziani
Postdoc, OT
University Hospital Bispebjerg and Frederiksberg