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Clinical Trials/NCT05829421
NCT05829421
Completed
Not Applicable

Feasibility of a Neuropsychologically Informed Occupational Therapy Intervention Targeting Decreased Ability to Perform Activities of Daily Living in People With Poststroke Cognitive Impairment

Emma Ghaziani4 sites in 1 country8 target enrollmentMay 25, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Impairment
Sponsor
Emma Ghaziani
Enrollment
8
Locations
4
Primary Endpoint
Change from baseline in ADL process skills level (assessed by the Assessment of Motor and Process Skills, AMPS) at 3 months poststroke
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 25, 2023
End Date
October 1, 2025
Last Updated
4 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Emma Ghaziani
Responsible Party
Sponsor Investigator
Principal Investigator

Emma Ghaziani

Postdoc, OT

University Hospital Bispebjerg and Frederiksberg

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change from baseline in ADL process skills level (assessed by the Assessment of Motor and Process Skills, AMPS) at 3 months poststroke

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (4)

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