Chronic StrokeNCT06630468
Task-Oriented Occupational Therapy Approach in Chronic Stroke: Performance, Balance, Quality of Life
A study testing Task-oriented occupational therapy (TOOT) in people with Chronic Stroke and Occupational Therapy, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Chronic stroke is a neurological disorder that leads to long-term disability and functional impairments in motor, sensory, cognitive, and speech functions, persisting beyond six months after the stroke incident. Read more about this study
- Who is it for?
- Ages 24 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Stroke, Occupational Therapy, Occupational Balance
- What is being tested?
- Task-oriented occupational therapy (TOOT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 1 Apr 2023
- 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 24 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18-65 years old,
- completed the acute phase of stroke
- experienced ischemic and/or hemorrhagic stroke
- had <=21 scores of Montreal Cognitive Assessment (MoCA)
- had <= 15 scores of the Rivermead Motor Assessment (RMA)
- had a motor stage of the hand and upper extremity motor stage level 3 or higher of the Brunnstrom Stages of Motor Recovery
- had scoring 2 or lower on the Modified Ashworth Scale for muscle tone around the shoulder, elbow, and wrist were included into the study.
Who cannot join
- Had an orthopedic problem affecting the upper extremity
- had undergone surgery in the past 6 months
- had a diagnosis related to a psychotic disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Task-oriented Occupational Therapy Intervention on Occupational Performance, Occupational Balance and Quality of Life Among Individuals with Chronic Stroke
Chronic stroke is a neurological disorder that leads to long-term disability and functional impairments in motor, sensory, cognitive, and speech functions, persisting beyond six months after the stroke incident. The purpose of this study was to investigate the effects of task- oriented occupational therapy intervention on occupational performance, occupational balance, and quality of life in individuals with chronic stroke. The study included 30 individuals with chronic stroke aged between 18 and 65, who were divided into two groups:
the task-oriented occupational therapy intervention group (TOOT) (n=15) and the control group (n=15). The participants in the TOOT group received task-oriented occupational therapy intervention in 30-minute sessions, five days a week, for four weeks, while the control group received routine upper-extremity-based occupational therapy intervention in a hospital setting.
- Being tested
- Task-oriented occupational therapy (TOOT), Control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task-oriented occupational therapy (TOOT)Other
Also called TOOT
The task-oriented occupational therapy intervention was applied to individuals in the TOOT group in the form of 30-minute sessions, 5 consecutive days a week, over 4 weeks.
Control groupOther
Routine upper-extremity-based occupational therapy intervention was applied to individuals in the TOOT group in the form of 30-minute sessions, 5 consecutive days a week, over 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Task-oriented occupational therapy (TOOT) | Experimental | The task-oriented occupational therapy intervention was applied to individuals in the TOOT group in the form of 30-minute sessions, 5 consecutive days a week, over 4 weeks. Receives: Other: Task-oriented occupational therapy (TOOT) |
| Control group | Active comparator | Routine upper-extremity-based occupational therapy intervention was applied to individuals in the TOOT group in the form of 30-minute sessions, 5 consecutive days a week, over 4 weeks. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measure
The task was used to evaluate occupational performance, developed by the Canadian Association of Occupational Therapists, the Canadian Occupational Performance Measure is used to identify problems in activity performance, measure changes in performance, and determine performance satisfaction. The Turkish cultural adaptation, validity, and reliability of this measurement tool were carried out by Torpil, with an internal consistency coefficient ranging from 0.9 to 1.
Measured: From enrollment to the end of treatment at 4 weeks
Occupational Balance Questionnaire-11 (OBQ11-T)
The task was used to evaluate occupational balance. The Occupational Balance Questionnaire is a questionnaire in which a person evaluates their occupational balance in relation to their current situation and daily life.
Measured: From enrollment to the end of treatment at 4 weeks
Stroke Impact Scale 3.0
The quality of life was evaluated with The Stroke Impact Scale. It is a self-report questionnaire that evaluates disability and health-related quality of life after stroke
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Dec 2022
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri City Hospital
- Sponsor type
- Other government
- Collaborators
- Medipol University
- Responsible party
- Principal investigator, Zeynep Şule Erkuvan, Kayseri City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630468
- Sponsor's protocol ID
- TOOT_OT_STROKE
- Other IDs
- Kayseri city hospital
- Status last verified
- Dec 2022
- First submitted
- 3 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Task-oriented Occupational Therapy Intervention on Occupational Performance, Occupational Balance and Quality of Life Among Individuals with Chronic Stroke
- ClinicalTrials.gov ID
- NCT06630468
- Acronym / sponsor ID
- TOOT_OT_STROKE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kayseri City HospitalOther government
- Collaborators
- Medipol University
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 8 Oct 2024 (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.
Chronic stroke is a neurological disorder that leads to long-term disability and functional impairments in motor, sensory, cognitive, and speech functions, persisting beyond six months after the stroke incident. The purpose of this study was to investigate the effects of task- oriented occupational therapy intervention on occupational performance, occupational balance, and quality of life in individuals with chronic stroke. The study included 30 individuals with chronic stroke aged between 18 and 65, who were divided into two groups:
the task-oriented occupational therapy intervention group (TOOT) (n=15) and the control group (n=15). The participants in the TOOT group received task-oriented occupational therapy intervention in 30-minute sessions, five days a week, for four weeks, while the control group received routine upper-extremity-based occupational therapy intervention in a hospital setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Task-oriented occupational therapy (TOOT) | Experimental | Other: Task-oriented occupational therapy (TOOT)The task-oriented occupational therapy intervention was applied to individuals in the TOOT group in the form of 30-minute sessions, 5 consecutive days a week, over 4 weeks. |
| Control group | Active comparator | Other: Control groupRoutine upper-extremity-based occupational therapy intervention was applied to individuals in the TOOT group in the form of 30-minute sessions, 5 consecutive days a week, over 4 weeks. |
Who may qualify
- Ages
- 24 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- aged 18-65 years old,
- completed the acute phase of stroke
- experienced ischemic and/or hemorrhagic stroke
- had <=21 scores of Montreal Cognitive Assessment (MoCA)
- had <= 15 scores of the Rivermead Motor Assessment (RMA)
Key exclusion criteria (3 listed)
- Had an orthopedic problem affecting the upper extremity
- had undergone surgery in the past 6 months
- had a diagnosis related to a psychotic disorder.
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 |
|---|---|---|
| Task-oriented occupational therapy (TOOT)Also: TOOTThe task-oriented occupational therapy intervention was applied to individuals in the TOOT group in the form of 30-minute sessions, 5 consecutive days a week, over 4 weeks. | Other | Task-oriented occupational therapy (TOOT) |
| Control groupRoutine upper-extremity-based occupational therapy intervention was applied to individuals in the TOOT group in the form of 30-minute sessions, 5 consecutive days a week, over 4 weeks. | Other | Control group |
Primary outcome
Canadian Occupational Performance Measure
Time frame: From enrollment to the end of treatment at 4 weeks
The task was used to evaluate occupational performance, developed by the Canadian Association of Occupational Therapists, the Canadian Occupational Performance Measure is used to identify problems in activity performance, measure changes in performance, and determine performance satisfaction. The Turkish cultural adaptation, validity, and reliability of this measurement tool were carried out by Torpil, with an internal consistency coefficient ranging from 0.9 to 1.
Occupational Balance Questionnaire-11 (OBQ11-T)
Time frame: From enrollment to the end of treatment at 4 weeks
The task was used to evaluate occupational balance. The Occupational Balance Questionnaire is a questionnaire in which a person evaluates their occupational balance in relation to their current situation and daily life.
Stroke Impact Scale 3.0
Time frame: From enrollment to the end of treatment at 4 weeks
The quality of life was evaluated with The Stroke Impact Scale. It is a self-report questionnaire that evaluates disability and health-related quality of life after stroke
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 8 Oct 2024.
- Individual participant dataSharing planned: Undecided. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Task-oriented occupational therapy (TOOT) in people with Chronic Stroke and Occupational Therapy, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
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 7 inclusion and 3 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 8 Oct 2024. 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 Turkey (Türkiye). 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?
Canadian Occupational Performance Measure (time frame: From enrollment to the end of treatment at 4 weeks). The study lists 3 primary outcomes in all. 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 8 Oct 2024.