Effect of Intensified Occupational Therapy on Basic Activities of Daily Living
1 other identifier
interventional
20
1 country
1
Brief Summary
The objective is to investigate the effect of an intensified occupational therapy intervention on independence in basic activities of daily living (ADL) in subjects with stroke
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2022
CompletedFirst Posted
Study publicly available on registry
December 6, 2022
CompletedStudy Start
First participant enrolled
February 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2025
CompletedJanuary 7, 2026
December 1, 2025
2.5 years
November 14, 2022
January 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of motor and process skills (AMPS)
Observed limitations in activities of daily living, with scores for the motor- and proces- domains of activitites of daily living abilities. Each item in the domains is scored on a 4-point Likert scale, with higher scores representing a better outcome.
Change in scores from baseline to scores following three weeks intervention
Secondary Outcomes (4)
Activities of Daily Living - Interview
Change in scores from baseline to scores following three weeks intervention
Functional Independence Measure (FIM)
Change in scores from baseline to scores following three weeks intervention
Goal Attainment Scaling
Following three weeks intervention
Length of stay
Follow-up up to one year of admission for inpatient rehabilitation.
Study Arms (2)
Intensified occupational therapy
EXPERIMENTALTwo hours occupational therapy each weekday with specific focus on basic ADL
Usual care
ACTIVE COMPARATOROccupational therapist instruct nursing staff on how to assist patients with basic ADL
Interventions
The intervention is an intensified occupational therapy effort, which does not take time away from other occupational therapy efforts.
Eligibility Criteria
You may qualify if:
- First-time stroke
- \<=4 on four of six Functional Independence Measure (FIM) basic ADL items
You may not qualify if:
- Not able to understand danish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hammel Neurorehabilitation Centre and University Research Clinic
Hammel, Central Jutland, 8450, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jesper Fabricius, PhD
Hammel Neurorehabilitation Centre and University Research Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2022
First Posted
December 6, 2022
Study Start
February 20, 2023
Primary Completion
August 15, 2025
Study Completion
August 15, 2025
Last Updated
January 7, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share