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Completed

NCT Number: NCT05638607

Effect of Intensified Occupational Therapy on Basic Activities of Daily Living

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

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Key information

Conditions

ADL Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hammel Neurorehabilitation Centre and University Research Clinic

Hammel, Central Jutland, 8450, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Not able to understand danish

Treatment and study plan

Intensified occupational therapy

Behavioral

The intervention is an intensified occupational therapy effort, which does not take time away from other occupational therapy efforts.

Primary outcomes

  1. Assessment of motor and process skills (AMPS)

    Time frame: 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 outcomes

  1. Activities of Daily Living - Interview

    Time frame: Change in scores from baseline to scores following three weeks intervention

    Patient reported outcome measure

  2. Functional Independence Measure (FIM)

    Time frame: 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.

  3. Goal Attainment Scaling

    Time frame: 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".

  4. Length of stay

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 6, 2022
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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