NCT06717776

Brief Summary

The aim of the study was to develop a Compensation-Based Problem-Solving Therapy and to examine its effects on occupational performance, participation, self-efficacy, and quality of life in individuals with stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable stroke

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

December 1, 2024

Last Update Submit

February 5, 2026

Conditions

Keywords

strokecompensationself-efficacyproblem solvingparticipation

Outcome Measures

Primary Outcomes (1)

  • The Canadian Occupational Performance Measure (COPM)

    The Canadian Occupational Performance Measure (COPM) is a measurement tool that is specific to the individual and is used to evaluate the performance and satisfaction of individuals in their activities of daily living. The COPM employs a person-centered approach, encompasses a comprehensive scope, and assesses performance and satisfaction. The tool includes the following components: problem definition, prioritization, scoring, goal setting, and re-evaluation. The COPM comprises three domains of occupational performance: self-care, work and productive activities, and leisure time activities. The individual's desired occupations within these areas are identified and assigned a score between 1 and 10. Subsequently, the five most significant occupations are identified from the aforementioned list and performance and satisfaction scores are assigned a value between 1 and 10. The total performance and total satisfaction levels of these occupations are then recorded. Additionally, the total

    1 month

Secondary Outcomes (3)

  • The Stroke Specific Quality of Life Scale (SSQLS)

    1 month

  • Daily Living Self Efficacy Scale

    1 month

  • Participation Scale

    1 month

Study Arms (2)

Aspirin (intervention group)

ACTIVE COMPARATOR

The intervention group received both compensation-bocused problem-solving therapy and standard rehabilitation services. Standard Rehabilitation:The program allows individuals to utilize the physiotherapy and occupational therapy units on a weekly basis, with access available on weekdays. Compensation Based Problem Solving Therapy (CFPS) is an approach based on the occupational adaptation model. It entails the implementation of compensatory strategies with the objective of enhancing the performance of both extremities in activities of daily living.

Behavioral: Compensation Based Problem Solving TherapyBehavioral: standard rehabilitation

Plasebo (control group)

ACTIVE COMPARATOR

The control group received standard rehabilitation services. Standard Rehabilitation:The program allows individuals to utilize the physiotherapy and occupational therapy units on a weekly basis, with access available on weekdays.

Behavioral: standard rehabilitation

Interventions

Compensation-Based Problem Solving Therapy (CB-PST) is a therapeutic approach based on the occupational adaptation model. It entails the implementation of compensatory strategies with the objective of enhancing the performance of both extremities in daily life activities. The therapy encompasses the implementation of problem-solving training. The occupational problem is defined. The development of compensation-focused strategies is based on the "personal factors" and "occupational environment" identified as relevant to the problematic occupation, as determined according to the principles of the occupational adaptation model. Once a compensatory strategy has been selected, the next step is to apply it and evaluate its efficacy, with the expectation that an "adaptive response" will be observed, and that the resulting adaptation will be reflected in improved occupational performance, as guided by the occupational adaptation model.

Aspirin (intervention group)

The standard rehabilitation program is provided to all individuals in the inpatient service on an equal basis. The program allows individuals to utilize the physiotherapy and occupational therapy units on a weekly basis, with access available on weekdays. These units are staffed by physiotherapists and occupational therapists. All individuals included in the study received the same service from the same therapists at the same times in a homogeneous manner. All individuals received physiotherapy, electrotherapy, and hydrotherapy as part of this service. In the physiotherapy unit, the first intervention was 25 minutes of electrotherapy for the upper extremity. This was followed by 40 minutes of physiotherapy exercises, conducted with the assistance of a physiotherapist. The final component of the physiotherapy unit programme was 15 minutes of hydrotherapy. In the occupational therapy unit, a standard 40-minute occupa

Aspirin (intervention group)Plasebo (control group)

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals with ischemic stroke due to middle cerebral artery lesion 18-64 years of age Stroke time between 3-12 months Scoring 24 and above on the Standardized Mini Mental Test Scoring 16 and below on the NIH Stroke Scale Receiving service in the inpatient service at Etlik City Hospital

You may not qualify if:

  • Having any psychiatric or neurological disease that may affect the study Individuals whose affected hand is not their dominant hand Individuals who tend to neglect their affected hand

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Etlik City Hospital

Ankara, Yenimahalle, 06800, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The therapist who conducted the assessment tests was unaware of the participants' group assignments (interventon or control)
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Two groups with an intervention group and a control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 1, 2024

First Posted

December 5, 2024

Study Start

September 1, 2024

Primary Completion

December 1, 2024

Study Completion

July 1, 2025

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations