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Completed

NCT Number: NCT06753877

Clinical Monitoring Using ICF

The present study examined stroke patients who applied to occupational therapy units within the framework of ICF, following the rehabilitation process, and defining frequently used measurements in terms of ICF codes

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mardin Traning and Rsearch Hospital

Mardin, Artuklu, 47060, Turkey (Türkiye)

About this study

The International Classification of Functioning (ICF) is a standardized method frequently used by health professionals. This follow-up study was performed in accordance with the Declaration of Helsinki. The present study examined stroke patients who applied to occupational therapy units within the framework of ICF, following the rehabilitation process, and defining frequently used measurements in terms of ICF codes. Participants were recruited from the patients who applied to the Occupational Therapy Clinic of Etlik City Hospital. Participants who agreed to participate in the study signed an informed consent form. First, the scales were defined within the framework of ICF. Individuals who had a stroke and were hospitalized in the Physiotherapy and Rehabilitation Clinic of Etlik City Hospital and included in the study were evaluated using ICF parameters within the first 3 days of their hospitalization. All individuals were given a holistic rehabilitation program. Individuals who received inpatient treatment and stayed in the hospital for one month were re-evaluated. Other individuals who were not included in the study benefited from traditional inpatient treatment services. Upon evaluating the rehabilitation service within the framework of ICF, significant changes were observed in body functions, activity, and participation. It is recommended that ICF be used by occupational therapists and other health professionals, that the scales be associated with ICF codes, and that holistic rehabilitation services be developed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of stroke, age between 18 and 64 years,
  • Being served by hospital, being enrolled in the occupational therapy,
  • Volunteering to participate in the study

Exclusion criteria

  • Individuals with orthopedic, psychological or neurological conditions other than stroke that could affect their functioning and those with moderate or severe aphasia were not included in the study

Treatment and study plan

holistic rehabilitation

Behavioral

Holistic rehabilitation service All participants in the study were cared for in the inpatient unit. The same physician and nurses followed the participants for 1 month. The participants were regularly taking their medication and had no co-morbidities. All participants stayed in double rooms and all stayed with their caregivers. The assessments were carried out within the first 3 days of admission to the inpatient unit. The second assessments were repeated by the same professional. Rehabilitation interventions were provided by different therapists. Participants were given standard physiotherapy services (electrotherapy, exercise, gait training, hydrotherapy, respiratory therapy) and standard occupational therapy services. Occupational therapy interventions were provided by the researchers. Physiotherapy services were provided by physiotherapists working full-time in the hospital. Physiotherapy was provided 5 days a week and occupational therapy was provided 3 days a week.

Primary outcomes

  1. Functional Independence Scale (FIM)

    Time frame: 1 month

    The FIM is a scale that measures a person's level of independence in basic motor and cognitive activities of daily living. It consists of 18 items and assesses 2 sub-areas. 1) motor function and 2) cognitive function. Each item is scored on a detailed scale ranging from 1 to 7 (level 1 = fully dependent, level 7 = fully independent). The total score ranges from 18 to 126. The higher the person's score, the higher the level of independence (Ravaud et al., 1999). The Turkish cultural adaptation study was conducted.

Secondary outcomes

  1. Mini Mental State Examination (MMSE)

    Time frame: 1 month

    The MMSE, which assesses cognitive impairment, is a scale developed. It is a useful, short and standardised tool that can be used to determine cognitive level. It consists of five main sections: orientation, registration, attention and calculation, recall, and language with a total of eleven items. The score range is 0-30. A higher score indicates a higher cognitive level. The Turkish validity and reliability were carried out.

Other outcomes

  1. Stroke Impact Scale version 3.0 (SIS v-3.0):

    Time frame: 1 month

    The SIS is a scale designed to assess clients' perceived quality of life after stroke. The scale was developed as SIS 2.0 and updated to SIS 3.0. It consists of 8 domains (strength, hand function, mobility, ADL/IADL, memory and thinking, communication, emotion, and social participation) and 59 questions. The degree of difficulty with activities in the past week is rated on a 5-point Likert scale. The score for each domain ranges from 0 to 100. In addition to the 8 sub-sections, the perception of recovery after stroke is assessed using a 0-100 point visual analog scale (0: no recovery, 100: full recovery). The Turkish validity and reliability study was conducted.

  2. Lawton-Brody Instrumental Activities of Daily Living (Lawton-Brody IADL)

    Time frame: 1 month

    This test, which measures the subjective level of independence in IADL, was developed. It consists of 8 questions about "ability to use phone, shopping, food preparation, housekeeping, laundry, mode of transportation, responsibility for own medications, ability to handle finances". It is scored on a 0-8 scale, with a low score indicating high dependency. The Turkish cultural adaptation study was conducted.

  3. Frenchay Activities Index (FAI):

    Time frame: 1 month

    The Frenchay Activities Index (FAI) is a scale designed to assess the activities of daily living and social participation of individuals. It consists of 15 items asking how often activities of daily living, such as preparing meals and washing up, and activities of social participation, such as socialising and driving, are performed. The first 10 items express the frequency of activities performed in the last three months and the remaining items express the frequency of activities performed in the last six months. Each item consists of a 4-point Likert scale (0=never, 3=at least once a week) and the total score ranges from 0 (not active) to 45 (very active). The Turkish cultural adaptation study was conducted.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Clinical Monitoring of Individuals With Stroke During Inpatient Rehabilitation Using ICF:A Short-Term Follow-Up Study

Acronym: ICF

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 31, 2024
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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