Activity Daily Living Performance in Patients With Stroke

Stroke Clinical Trial

Official title:

Investigation of Activity Daily Living Performance in Patients With Chronic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03723213
• Other study ID #: KU GOKAEK 2018/251
• Status: Recruiting
• Start date: October 24, 2018
• Est. completion date: October 11, 2019

Study information

• Verified date: October 2018
• Source: Kocaeli University
• Contact: cigdem cekmece
• Phone: 05335483955
• Email: cigdemcekmece[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: October 11, 2019
• Est. primary completion date: February 12, 2019
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
Turkey	Cigdem Cekmece	Kocaeli	Izmit
Turkey	Cigdem Cekmece	Kocaeli	Yahya Kaptan

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 weeks interval
Secondary	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.	3 weeks interval
Secondary	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.	3 weeks interval
Secondary	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.	3 weeks interval
Secondary	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.	3 weeks interval
Secondary	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.	3 weeks interval