Clinical trial NCT03723213: Activity Daily Living Performance in Patients With Stroke
Official title: Investigation of Activity Daily Living Performance in Patients With Chronic Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: stroke
occupational therapy
activity daily living
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2018-10-29
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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,
* 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

Exclusion Criteria:

* 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,
* 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

Primary outcomes:
measure: canadian occupational performance measure (COPM)
timeFrame: 3 weeks interval
Secondary outcomes:
measure: Modified Ashworth Scale (MAS)
timeFrame: 3 weeks interval
measure: Brunnstrom's Hemiplegia Recovery Staging
timeFrame: 3 weeks interval
measure: Mini Mental Stage Examination
timeFrame: 3 weeks interval
measure: The Barthel Activity Daily Living Index
timeFrame: 3 weeks interval
measure: The Frenchay Activities Index (FAI)
timeFrame: 3 weeks interval
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Cigdem Cekmece
state: İzmit
city: Kocaeli
country: Turkey
facility: Cigdem Cekmece
state: Yahya Kaptan
Study officials:
affiliation: Kocaeli University
name: elif ozcan
role: STUDY_CHAIR
References: