StrokeNCT03723213
Activity Daily Living Performance in Patients With Stroke
An observational study of Stroke, run by Kocaeli University at 2 sites in Turkey (Türkiye).
Trial summary
In the rehabilitation of stroke patients, the emphasis is on the treatment of physical pathologies such as increased range of motion and muscle strength, reduction of spasticity and pain. All these treatments provide increased physical capacity of the patient. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke
- How many people
- 26 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 24 Oct 2018to 11 Oct 2019
- How long will I take part?
- 5 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: In this study we will take patients depends on a article's statistics that called "Combined Cognitive-Strategy and TaskSpecific Training Improve Transfer to Untrained Activities in Subacute Stroke: An Exploratory Randomized Controlled Trial". We calculated the power analysis from this article. According to this calculated; α=0.05, 1-β=0.20, influence quantity=0.69. Between September 10, 2018 and February 11, 2019, 26 stroke patients between the ages of 18-65 who applied for rehabilitation treatment in Kocaeli University Faculty of Medicine Department of Physical Medicine and Rehabilitation will be included.
Who may be able to join
- Being 18 between 65 years of age,
- To be volunteer,
- Stability of medical conditions of patients,
- Have a sufficient communication skills,
- There will be not severe pain that will affect the treatment
- At least three months after cerebrovascular disease,
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- Hemiplegia depends on cerebrovascular disease
- There will be not serious cognitive defect [Mini Mind Test (MMT) score of 24 and above],
- The patients have to have Stage of Brunnstrom is III or more appropriate,
- Modified Ashworth Scale (MAS) score has to be 2 and below
- Independent seating balance
Who cannot join
- To be an acute term stroke
- Patient consciousness is closed,
- Having a history of stroke before,
- Having a history of spinal cord lesion, traumatic brain injury, other accompanying neurological disease (multiple sclerosis, Parkinson's disease, dementia) or lower motor neuron disease,
- Having a history of tumor, convulsion,
- An important comorbid disease, such as severe heart disease (aortic stenosis, angina, arrhythmia, pacemaker) and uncontrolled hypertension, which may prevent rehabilitation, epileptic seizure history,
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- No volunteer
- Excessive spasticity in the affected upper extremity joints (shoulder, elbow, wrist, fingers) [Modified Ashworth Scale (MAS) score is ≥ 3,
- Lack of sitting balance
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Cigdem Cekmece
Kocaeli, İzmit, 41040
cigdem cekmece, 05335483955, cigdemcekmece@yahoo.com
ilgin sade, 05332264615, ilginsade@gmail.com
- Not yet recruiting
Cigdem Cekmece
Kocaeli, Yahya Kaptan, 41040
cigdem cekmece, assist.prof., 05335483955, cigdemcekmece@yahoo.com
ilgin sade, assist.prof., 05332264615, ilginsade@gmail.com
About this study
Official title: Investigation of Activity Daily Living Performance in Patients With Chronic Stroke
In the rehabilitation of stroke patients, the emphasis is on the treatment of physical pathologies such as increased range of motion and muscle strength, reduction of spasticity and pain. All these treatments provide increased physical capacity of the patient. But these are not enough for perform the activity daily living. In order to be successful in activity daily living of the patient, performance based treatment methods should also be applied.
The use of Canadian Occupational Performance Measurement (COPM), which measures patients' defined problem areas in daily practice should contribute to the patient-oriented approach process.
Read the detailed description
In the rehabilitation of stroke patients, the emphasis is on the treatment of physical pathologies such as increased range of motion and muscle strength, reduction of spasticity and pain. All these treatments provide increased physical capacity of the patient. But these are not enough for perform the activity daily living. In order to be successful in activity daily living of the patient, performance based treatment methods should also be applied.
The use of Canadian Occupational Performance Measurement (COPM), which measures patients' defined problem areas in daily practice should contribute to the patient-oriented approach process.The Canadian Occupational Performance Measure (COPM) is an important tool to enable personalized health care.One of the strengths of the measure is its broad focus on occupational performance in all areas of life, including self-care, leisure and productivity, taking into account development throughout the lifespan and the personal life circumstances.
COPM has been described as having various advantages in terms of increasing applicability, responsibility and motivation for occupational therapy.There are two focus points in the COPM. The first one is the person-centered; the second is activity performance appropriate to the person's wishes.
By using conventional methods in stroke rehabilitation, contractures and deformities that may occur in patients can be reduced, muscle strength can be increased, and inadequate gait failure in patients can be minimized.
However, in many activities needed for daily living activities, the patient is able to sustain his inadequacy such as dressing, eating, bathing, going to the store. With the application of COPM, deficiencies in patients and the most important needs can be emphasized; thus, a program can be prepared during the treatment process. As the COPM test is a patient-centered test, it has an important place in occupational therapy programs.
In this study, Frenchay Activities Index, Barthel ADL Index and COPM will be applied in order to focus on the performances that stroke patients need in their daily living activities and to improve the independence of the patients and to emphasize patient-focused treatment. After the tests are applied, the rehabilitation process will be conducted by a treatment plan according to the needs of the patients.After the treatments, the tests will be repeated and the success rate will be evaluated on the patients.
- Conditions
- Stroke
- Keywords
- stroke, occupational therapy, activity daily living
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
canadian occupational performance measure (COPM)
COPM has a client-centered design and measures outcomes according to three occupational performance areas (self-care, productivity, and leisure), examining self-perceived changes in the occupational performance of patients through a semistructured interview. The COPM prompts discussion between interviewees and therapists on factors such as different areas of activity, their concerns, and problems to be resolved. At the beginning, patients start by identifying their difficulties according to the three occupational performance areas. They subsequently use a 10-point Likert-type scale, ranging from not at all crucial (1) to extremely crucial (10), to identify the intensity of certain difficulties. For the top five problems or tasks selected by patients, the interviewer asks them to continue identifying their performance and satisfaction with their performance by using the same 10-point rating scale. Accordingly, therapists focus on these main problems or tasks.
Measured: 3 weeks interval
Secondary outcomes (5)
Modified Ashworth Scale (MAS)
The MAS measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity.
Scoring:
0: No increase in muscle tone
- Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion
- More marked increase in muscle tone through most of the range of motion, but affected part(s) easily moved
- Considerable increase in muscle tone, passive movement difficult
- Affected part(s) rigid in flexion or extension Patients will be evaluated according to the modified ashworth scale described above.
Spasticity of patients with MAS score 2 and below does not affect daily living activities very much. MAS has a minimal spasticity in patients with a total score of 2 and below.
Measured: 3 weeks interval
Brunnstrom's Hemiplegia Recovery Staging
Therapist evaluates patient who suffered from stroke for determine the stage of recovery.
There are a total of six stages in the Upper Extremity Motor Recovery Phase. There are a total of six stages in the Motor Recovery Phase. In the investigator's study, 3 or more points will be accepted for each staging.
Measured: 3 weeks interval
Mini Mental Stage Examination
The Mini Mental State Examination (MMSE) is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is also used to estimate the severity and progression of cognitive impairment and to follow the course of cognitive changes in an individual over time; thus making it an effective way to document an individual's response to treatment.
Measured: 3 weeks interval
The Barthel Activity Daily Living Index
Occupational therapist evaluates each patient in activity daily living. This scale include 10 items such as feeding (score between 0 and 10), bathing (score between 0 and 5), grooming (score between 0 and 5), dressing (score 0 and 10), bowels (score beween 0 and 10), bladder (score between 0 and 10), toilet use (score between 0 and 10), transfers (score berween 0 and 15), mobility (score between 0 and 15), stairs (score between 0 and 10).
Evaluation of total score; 0-20: fully dependent 21-61: highly dependent 62-90: moderately dependent 91-99: slightly dependent 100: fully independent Patients with a score of 90 and above had more status.
Measured: 3 weeks interval
The Frenchay Activities Index (FAI)
FAI is a measure of instrumental activities of daily living for use with patients recovering from stroke.
Frenchay activity index consists of 15 items. The first 10 items are evaluated in the last 3 months. Each item is awarded a score of 0-3. The first 10 items are; food preparation, washing dishes after meals, clothes washing, light housework, heavy house forward, local shopping, social situations, more than 15 minutes walking outside, hobbies, ride the car or ride the bus.
The last 5 items are evaluated in the last 6 months. Each item is awarded a score of 0-3. The last 5 items are; travel trip or car driving, horticultural, home care, reading, profitable business.
The benefit of the FAI is that while activities of daily living scales tend to focus on issues related to self-care and mobility.
Total scores will be compared before and after the study.
Measured: 3 weeks interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start24 Oct 2018
- Primary completion12 Feb 2019
- Study completion11 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 26 participants (estimated)
- Target duration
- 5 Months
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çiğdem Çekmece, Kocaeli University
- Investigators
- elif ozcan, Study chair, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723213
- Sponsor's protocol ID
- KU GOKAEK 2018/251
- Status last verified
- Oct 2018
- First submitted
- 23 Oct 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Activity Daily Living Performance in Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT03723213
- Acronym / sponsor ID
- KU GOKAEK 2018/251
- Conditions
- Stroke
- Keywords
- stroke, occupational therapy, activity daily living
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 12 Feb 2019 (actual)
- Study completion
- 11 Oct 2019 (estimated)
- First posted
- 29 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the rehabilitation of stroke patients, the emphasis is on the treatment of physical pathologies such as increased range of motion and muscle strength, reduction of spasticity and pain. All these treatments provide increased physical capacity of the patient. But these are not enough for perform the activity daily living. In order to be successful in activity daily living of the patient, performance based treatment methods should also be applied.
The use of Canadian Occupational Performance Measurement (COPM), which measures patients' defined problem areas in daily practice should contribute to the patient-oriented approach process.
Detailed description
In the rehabilitation of stroke patients, the emphasis is on the treatment of physical pathologies such as increased range of motion and muscle strength, reduction of spasticity and pain. All these treatments provide increased physical capacity of the patient. But these are not enough for perform the activity daily living. In order to be successful in activity daily living of the patient, performance based treatment methods should also be applied.
The use of Canadian Occupational Performance Measurement (COPM), which measures patients' defined problem areas in daily practice should contribute to the patient-oriented approach process.The Canadian Occupational Performance Measure (COPM) is an important tool to enable personalized health care.One of the strengths of the measure is its broad focus on occupational performance in all areas of life, including self-care, leisure and productivity, taking into account development throughout the lifespan and the personal life circumstances.
COPM has been described as having various advantages in terms of increasing applicability, responsibility and motivation for occupational therapy.There are two focus points in the COPM. The first one is the person-centered; the second is activity performance appropriate to the person's wishes.
By using conventional methods in stroke rehabilitation, contractures and deformities that may occur in patients can be reduced, muscle strength can be increased, and inadequate gait failure in patients can be minimized.
However, in many activities needed for daily living activities, the patient is able to sustain his inadequacy such as dressing, eating, bathing, going to the store. With the application of COPM, deficiencies in patients and the most important needs can be emphasized; thus, a program can be prepared during the treatment process. As the COPM test is a patient-centered test, it has an important place in occupational therapy programs.
In this study, Frenchay Activities Index, Barthel ADL Index and COPM will be applied in order to focus on the performances that stroke patients need in their daily living activities and to improve the independence of the patients and to emphasize patient-focused treatment. After the tests are applied, the rehabilitation process will be conducted by a treatment plan according to the needs of the patients.After the treatments, the tests will be repeated and the success rate will be evaluated on the patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Months
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- In this study we will take patients depends on a article's statistics that called "Combined Cognitive-Strategy and TaskSpecific Training Improve Transfer to Untrained Activities in Subacute Stroke: An Exploratory Randomized Controlled Trial". We calculated the power analysis from this article. According to this calculated; α=0.05, 1-β=0.20, influence quantity=0.69. Between September 10, 2018 and February 11, 2019, 26 stroke patients between the ages of 18-65 who applied for rehabilitation treatment in Kocaeli University Faculty of Medicine Department of Physical Medicine and Rehabilitation will be included.
Key inclusion criteria (11 listed)
- Being 18 between 65 years of age,
- To be volunteer,
- Stability of medical conditions of patients,
- Have a sufficient communication skills,
- There will be not severe pain that will affect the treatment
Key exclusion criteria (9 listed)
- To be an acute term stroke
- Patient consciousness is closed,
- Having a history of stroke before,
- Having a history of spinal cord lesion, traumatic brain injury, other accompanying neurological disease (multiple sclerosis, Parkinson's disease, dementia) or lower motor neuron disease,
- Having a history of tumor, convulsion,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
canadian occupational performance measure (COPM)
Time frame: 3 weeks interval
COPM has a client-centered design and measures outcomes according to three occupational performance areas (self-care, productivity, and leisure), examining self-perceived changes in the occupational performance of patients through a semistructured interview. The COPM prompts discussion between interviewees and therapists on factors such as different areas of activity, their concerns, and problems to be resolved. At the beginning, patients start by identifying their difficulties according to the three occupational performance areas. They subsequently use a 10-point Likert-type scale, ranging from not at all crucial (1) to extremely crucial (10), to identify the intensity of certain difficulties. For the top five problems or tasks selected by patients, the interviewer asks them to continue identifying their performance and satisfaction with their performance by using the same 10-point rating scale. Accordingly, therapists focus on these main problems or tasks.
5 secondary outcomes
Modified Ashworth Scale (MAS)
Time frame: 3 weeks interval
Brunnstrom's Hemiplegia Recovery Staging
Time frame: 3 weeks interval
Mini Mental Stage Examination
Time frame: 3 weeks interval
The Barthel Activity Daily Living Index
Time frame: 3 weeks interval
The Frenchay Activities Index (FAI)
Time frame: 3 weeks interval
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
elif ozcan study chair
Kocaeli University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Kocaeli University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact cigdem cekmece (05335483955, cigdemcekmece@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
canadian occupational performance measure (COPM) (time frame: 3 weeks interval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019; AzTrials last refreshed its copy on 4 Nov 2026.