NCT05638607

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 6, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

February 20, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

January 7, 2026

Status Verified

December 1, 2025

Enrollment Period

2.5 years

First QC Date

November 14, 2022

Last Update Submit

January 6, 2026

Conditions

Keywords

StrokeOccupational therapyTrialBasic activities of daily living

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

EXPERIMENTAL

Two hours occupational therapy each weekday with specific focus on basic ADL

Behavioral: Intensified occupational therapy

Usual care

ACTIVE COMPARATOR

Occupational therapist instruct nursing staff on how to assist patients with basic ADL

Behavioral: Intensified occupational therapy

Interventions

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

Intensified occupational therapyUsual care

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jesper Fabricius, PhD

    Hammel Neurorehabilitation Centre and University Research Clinic

    PRINCIPAL INVESTIGATOR

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

Locations