Clinical trial NCT06845566: Formulation of Compensation Based Intervention
Official title: Formulation of a Novel Compensation Based Intervention to Improve Activities of Daily Living: A Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: activities of daily living
stroke
compensatory
problem solving
participation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups with an intervention group and a control group
Primary purpose: BASIC_SCIENCE

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 prospective and 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Canadian Occupational Performance Measure (COPM)
timeFrame: 1 month
Secondary outcomes:
measure: Functional Independence Scale (FIM)
timeFrame: 1 month
Other outcomes:
measure: Lawton-Brody Instrumental Activities of Daily Living (Lawton-Brody IADL)
timeFrame: 1 month
measure: Frenchay Activities Index (FAI):
timeFrame: 1 month
Locations:
city: Mardin
country: Turkey
facility: Mardin Traning and Research Hospital
state: Artuklu
city: Mardin
country: Turkey
facility: Mardin Traning and Research Hospital
state: Artuklu
Study officials:
References: