Effect of Intensified Occupational Therapy on Basic Activities of Daily Living

Study Overview
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Brief Summary
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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

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

Conditions
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ADL

Intervention / Treatment
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* Behavioral: Intensified occupational therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: <4 on four of six Functional Independence Measure (FIM) basic ADL items Exclusion Criteria: Not able to understand danish

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Occupational therapy, Trial, Basic activities of daily living