- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06630468
Task-Oriented Occupational Therapy Approach in Chronic Stroke: Performance, Balance, Quality of Life
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kayseri, Turkey, 38080
- Kayseri City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Had an orthopedic problem affecting the upper extremity
- had undergone surgery in the past 6 months
- had a diagnosis related to a psychotic disorder.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
Other Names:
|
|
Active Comparator: Control group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From enrollment to the end of treatment at 4 weeks
|
|
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.
|
From enrollment to the end of treatment at 4 weeks
|
|
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
|
From enrollment to the end of treatment at 4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TOOT_OT_STROKE
- Kayseri city hospital (Kayseri city hospital)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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