Effect of Intensified Occupational Therapy on Basic Activities of Daily Living

Sponsor

University of Aarhus (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05638607

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
ADL	Behavioral: Intensified occupational therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 15, 2023

Anticipated Primary Completion Date :

Feb 15, 2024

Anticipated Study Completion Date :

Feb 15, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Assessment of motor and process skills (AMPS) [Change in scores from baseline to scores following three weeks intervention]
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.

Secondary Outcome Measures

Activities of Daily Living - Interview [Change in scores from baseline to scores following three weeks intervention]
Patient reported outcome measure
Functional Independence Measure (FIM) [Change in scores from baseline to scores following three weeks intervention]
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.
Goal Attainment Scaling [Following three weeks intervention]
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".
Length of stay [Follow-up up to one year of admission for inpatient rehabilitation.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

<4 on four of six Functional Independence Measure (FIM) basic ADL items

Exclusion Criteria:

Not able to understand danish

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Aarhus

Investigators

Principal Investigator: Jesper Fabricius, PhD, Hammel Neurorehabilitation Centre and University Research Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Aarhus

ClinicalTrials.gov Identifier:

NCT05638607

Other Study ID Numbers:

1-10-72-169-22

First Posted:

Dec 6, 2022

Last Update Posted:

Dec 6, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Aarhus

Stroke

Occupational therapy

Trial

Basic activities of daily living

Study Results

No Results Posted as of Dec 6, 2022