ADLNCT05638607
Effect of Intensified Occupational Therapy on Basic Activities of Daily Living
A study testing Intensified occupational therapy in people with ADL, run by University of Aarhus at 1 site in Denmark.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ADL
- What is being tested?
- Intensified occupational therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Feb 2023to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First-time stroke
- <=4 on four of six Functional Independence Measure (FIM) basic ADL items
Who cannot join
- Not able to understand danish
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Hammel Neurorehabilitation Centre and University Research Clinic
Hammel, Central Jutland, 8450
About this study
Official title: 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
- Conditions
- ADL
- Being tested
- Intensified occupational therapy
- Keywords
- Stroke, Occupational therapy, Trial, Basic activities of daily living
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensified occupational therapyBehavioural
The intervention is an intensified occupational therapy effort, which does not take time away from other occupational therapy efforts.
| Study group | Role | What they receive |
|---|---|---|
| Intensified occupational therapy | Experimental | Two hours occupational therapy each weekday with specific focus on basic ADL Receives: Behavioral: Intensified occupational therapy |
| Usual care | Active comparator | Occupational therapist instruct nursing staff on how to assist patients with basic ADL Receives: Behavioral: Intensified occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in scores from baseline to scores following three weeks intervention
Secondary outcomes (4)
Activities of Daily Living - Interview
Patient reported outcome measure
Measured: 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.
Measured: 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".
Measured: 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.
Measured: Follow-up up to one year of admission for inpatient rehabilitation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start20 Feb 2023
- Primary completion15 Aug 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADLStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jesper Fabricius, PhD, Principal investigator, Hammel Neurorehabilitation Centre and University Research Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638607
- Sponsor's protocol ID
- 1-10-72-169-22
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2022
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intensified Occupational Therapy on Basic Activities of Daily Living: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05638607
- Acronym / sponsor ID
- 1-10-72-169-22
- Conditions
- ADL
- Keywords
- Stroke, Occupational therapy, Trial, Basic activities of daily living
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensified occupational therapy | Experimental | Behavioral: Intensified occupational therapyTwo hours occupational therapy each weekday with specific focus on basic ADL |
| Usual care | Active comparator | Behavioral: Intensified occupational therapyOccupational therapist instruct nursing staff on how to assist patients with basic ADL |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- First-time stroke
- <=4 on four of six Functional Independence Measure (FIM) basic ADL items
Key exclusion criteria (1 listed)
- Not able to understand danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensified occupational therapyThe intervention is an intensified occupational therapy effort, which does not take time away from other occupational therapy efforts. | Behavioural | Intensified occupational therapy, Usual care |
Primary outcome
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.
4 secondary outcomes
Activities of Daily Living - Interview
Time frame: Change in scores from baseline to scores following three weeks intervention
Functional Independence Measure (FIM)
Time frame: Change in scores from baseline to scores following three weeks intervention
Goal Attainment Scaling
Time frame: Following three weeks intervention
Length of stay
Time frame: Follow-up up to one year of admission for inpatient rehabilitation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesper Fabricius, PhD principal investigator
Hammel Neurorehabilitation Centre and University Research Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensified occupational therapy in people with ADL, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of motor and process skills (AMPS) (time frame: Change in scores from baseline to scores following three weeks intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.