Effect of Intensified Occupational Therapy on Basic Activities of Daily Living

Effect of Intensified Occupational Therapy on Basic Activities of Daily Living: a Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: ADL
• Intervention / Treatment: Behavioral: Intensified occupational therapy

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Central Jutland
    • Hammel, Central Jutland, Denmark, 8450
      • Hammel neurorehabilitation centre and university research clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• First-time stroke
• <=4 on four of six Functional Independence Measure (FIM) basic ADL items

Exclusion Criteria:

• Not able to understand danish

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intensified occupational therapy; Two hours occupational therapy each weekday with specific focus on basic ADL	Behavioral: Intensified occupational therapy; The intervention is an intensified occupational therapy effort, which does not take time away from other occupational therapy efforts.
Active Comparator: Usual care; Occupational therapist instruct nursing staff on how to assist patients with basic ADL	Behavioral: Intensified occupational therapy; The intervention is an intensified occupational therapy effort, which does not take time away from other occupational therapy efforts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activities of Daily Living - Interview	Patient reported outcome measure	Change in scores from baseline to scores following three weeks intervention
Functional Independence Measure (FIM)	FIM measures activities of daily living observed by the interdisciplinary team in routinely daily practice. The scale has 18 items which are scored on a 7 point Likert Scale. The total score thus range from 18 to 126, with higher scores represent a better outcome.	Change in scores from baseline to scores following three weeks intervention
Goal Attainment Scaling	Scoring system based on rehabilitation goal setting. Each rehabilitation goal is rated on a 5-point Likert scale from -2 to +2 with higher score representing a better outcome. Examples are: -2 denoting "much less than expected" and +2 denoting "much more than expected".	Following three weeks intervention
Length of stay	Length of stay starts the day the patient is admitted for subacute rehabilitation and ends the day the patient is discharged. The mean length of stay at the hospital is arround 6 weeks.	Follow-up up to one year of admission for inpatient rehabilitation.

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Jesper Fabricius, PhD, Hammel neurorehabilitation centre and university research clinic

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2023
• Primary Completion (Actual): August 15, 2025
• Study Completion (Actual): August 15, 2025

Study Registration Dates

• First Submitted: November 14, 2022
• First Submitted That Met QC Criteria: December 2, 2022
• First Posted (Actual): December 6, 2022

Study Record Updates

• Last Update Posted (Estimated): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Stroke; Occupational therapy; Trial; Basic activities of daily living
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 1-10-72-169-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No