NCT06630468

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 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

Study Start

First participant enrolled

December 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
Last Updated

October 8, 2024

Status Verified

December 1, 2022

Enrollment Period

4 months

First QC Date

October 3, 2024

Last Update Submit

October 5, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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

    From enrollment to the end of treatment at 4 weeks

Study Arms (2)

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.

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.

Other: Control group

Interventions

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.

Also known as: TOOT
Task-oriented occupational therapy (TOOT)

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.

Control group

Eligibility Criteria

Age24 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Had an orthopedic problem affecting the upper extremity
  • had undergone surgery in the past 6 months
  • had a diagnosis related to a psychotic disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kayseri city hospital

Kayseri, 38080, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Investigator was blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Occupational Therapist

Study Record Dates

First Submitted

October 3, 2024

First Posted

October 8, 2024

Study Start

December 1, 2022

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

October 8, 2024

Record last verified: 2022-12

Locations