Formulation of Compensation Based Intervention

NCT06845566 | Completed

• 1 other identifier: HÜ-OT-LKO-03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Conditions

Stroke

Keywords

activities of daily living; stroke; compensatory; problem solving; participation

Outcome Measures

Primary Outcomes (1)

• The Canadian Occupational Performance Measure (COPM)

  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.

  1 month

Secondary Outcomes (1)

• Functional Independence Scale (FIM)

  1 month

Other Outcomes (2)

• Lawton-Brody Instrumental Activities of Daily Living (Lawton-Brody IADL)

  1 month

• Frenchay Activities Index (FAI):

  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 Therapy; Behavioral: 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 BEHAVIORAL

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)

standard rehabilitation BEHAVIORAL

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 occupational therapy was completed

Aspirin (intervention group); Plasebo (control group)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (2)

Mardin Traning and Research Hospital

Mardin, Artuklu, 47060, Turkey (Türkiye)

Location

Mardin Traning and Research Hospital

Mardin, Artuklu, 47, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular 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
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two groups with an intervention group and a control group

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 25, 2025
• Study Start: February 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 10, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)