Formulation of a Novel Compensation Based Intervention to Improve Functional Independence

Not Applicable

Completed

• Conditions: Stroke

• Registration Number: NCT06845566
• Lead Sponsor: Hacettepe University

Brief Summary

The primary aim of this study was to pilot CBPST as a novel intervention method. By applying it to a pilot group, the research sought to contribute to the existing literature by offering a compensation-based rehabilitation approach

Detailed Description

The study was designed as a randomized controlled pilot study. A simple randomization method was employed to randomly assign individuals to two groups (intervention and control groups). A simple randomization method was employed, whereby the intervention and control group papers were selected from a closed envelope. Following the initial evaluation of each participant, one of the papers bearing the designation "intervention" or "control" was selected at random. This decision determined whether the individual would be included in the intervention or control group. The study was conducted in the occupational therapy department of the physical therapy and rehabilitation clinic of Etlik City Hospital. The study was approved by the Ethics Committee of Etlik City Hospital and was assigned the code AEŞH-EK-2025-025. Following approval from the ethics committee, the Compensation-Based Problem Solving Training (CBPST) was developed. The training program was developed in accordance with the tenets of the Occupational Adaptation Model. All subsequent steps were conducted in accordance with the aforementioned model. The adaptive response, as outlined in the model, encompasses the occupational adaptation that is anticipated to occur at the conclusion of the training program. The therapy was then trialled with a pilot group of five individuals, with the aim of refining the content. Subsequently, the final iteration of the training program was established. All individuals included in the study signed a consent form indicating their willingness to participate. This was completed at the outset of the study. All individuals were provided with a standard rehabilitation program comprising five days a week (40 minutes) of routine therapy. In addition to this, the intervention group received CBPST in the form of five days a week (20 minutes) sessions. The evaluations completed at the beginning of the training were repeated one month later.

Study Timeline

• Study Start: 2024-12-01
• Primary Completion: 2025-02-01
• Study First Submitted: 2025-02-20
• Study First Submitted QC: 2025-02-20
• Study First Posted: 2025-02-25
• Study Completion: 2025-03-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• a diagnosis of ischemic stroke due to a middle cerebral lesion,
• age between 18 and 64 years,
• a score of 24 or above on the Standardized Mini-Mental State Examination --
• willingness to participate in the study.

Exclusion Criteria

• Stroke onset between 3 and 12 months prior to the study,
• presence of aphasia (speech impairment)
• diagnosis of another chronic condition that could affect study outcomes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Canadian Occupational Performance Measure (COPM)	1 month	It is a scale that includes a semi-structured interview. Activities that individuals have problems with or want to do in self-care, work and productive activities, and leisure activities are determined and given importance points. Then, the most important activities are ranked, and performance and satisfaction points are requested.These scores are made between 0 and 10. The final score is determined by adding the maximum of five activity, performance, and satisfaction scores. The validity and reliability of the scale have been established in the Turkish context.

Secondary Outcome Measures

Name	Time	Method
Functional Independence Scale (FIM)	1 month	It is a particularly noteworthy instrument. The FIM was developed to measure independence in daily living activities. The FIM comprises two sub-domains: motor and cognitive status, each with 18 items. The motor sub-domain encompasses 13 items, including feeding, bathing, and transferring, while the cognitive sub-domain comprises 5 items such as understanding, expressing, and social participation. Each item is scored on a scale ranging from 1 to 7, with higher scores indicating greater independence. A standardized guideline exists to facilitate the scoring process. Scores obtained are indicative of functionality levels. A Turkish validity and reliability study has been conducted.

Trial Locations

Locations (1)

Mardin Traning and Research Hospital; 🇹🇷 Mardin, Artuklu, Turkey