- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04084002
Physical Activity and Related Factors in a Sample of Turkish Patients With Stroke
Evaluation of Physical Activity and Related Factors in a Sample of Turkish Patients With Stroke
Study Overview
Detailed Description
The aim of this study was to investigate the relationships between physical activity level and demographic factors, motor function, cognitive function, functional status, balance and quality of life in patients with chronic stroke and to compare physical activity levels with healthy individuals in the same population. It is a fact that the physical activity levels of individuals decrease significantly after stroke. However, there is no study examining to what extent the physical activity is affected and the factors related to the decrease in the level of physical activity. The primary aim of stroke rehabilitation is to recognize and prevent complications, to minimize disturbances, to maximize functions. Secondary objectives; to prevent stroke recurrence. Physical activity has been shown to reduce the risk of stroke, stroke severity and other consequences. The risk of a reduction in physical capacity occurs over time and it is assumed that normal physical activity can prevent recurrent stroke. Therefore, it is necessary to continuously assess physical activity levels after stroke. In order to increase physical activity levels, it is important to identify people with low levels of physical activity and to understand the factors that may be associated. Therefore, in this study, we aimed to provide a comprehensive analysis by including most of the factors that may be related to physical activity in patients with stroke. In this study, unlike previous studies on physical activity in stroke, the relationships between physical activity and factors such as motor function, quality of life and cognitive skills as well as balance measurements and walking speed parameters which will be obtained from computerised posturography will be examined. In previous studies Physical Activity Scale for Elderly (PASE) questionnaire or the accelerometer device are used for the measurement of physical activity level. In this study, both of these tools will be used and the correlation between these two assessment tools will be demonstrated. In this study, patients with stroke will be evaluated by using PASE scale and accelerometer results (accelerometer will be held from Monday to Friday) for physical activity and Mini Mental test for cognitive function, Fugl Meyer Scale for motor function, Berg Balance Test and computerized posturography analysis for balance, Barthel Index for daily activities, Stroke Impact Scale for quality of life, Brunnstrom stage for motor recovery status. Each of the tests lasts about 5-10 minutes. Healthy control group will also be assessed via accelerometer and PASE questionnaire for physical activity and computerized posturography for balance.
With this study, physical activity which is protective for recurrent stroke, will be evaluated comprehensively and factors associated with physical activity will be revealed. Thus, in order to increase the physical activity, it will be concluded which factor should be treated or evaluated, and these results will be very helpful for further studies.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey, 34899
- Recruiting
- Marmara University School of Medicine, Pendik Research and Education Hospital, Department of Physical Medicine and Rehabilitation
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Contact:
- Naime Evrim Karadag Saygi, Prof
- Phone Number: 1628 00902166570606
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Contact:
- Esra G Giray, MD
- Phone Number: 1628 00902166570606
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Principal Investigator:
- Nurullah Eren, PT
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Principal Investigator:
- Esra Giray, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Patient group
- Patients with first ever, unilateral stroke
- Patients with stroke who can walk independently or with an assistive device
- Being at between the ages of 40-80 Control group
1. Being at between the ages of 40-80 and having not previously diagnosed with any neurologic disease
Exclusion Criteria:
Patient group
- Having uncontrolled hypertension, cardiopulmonary disease
- Presence of neglect, dementia, apraxia
- Mini mental scale >24 or being able to complete study outcomes
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with subacute chronic stroke
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Physical activity will be measured via accelerometer and self reported questionnaire (Physical activity scale for elderly)
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|
Control group
Healthy control group age and sex matched
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Physical activity will be measured via accelerometer and self reported questionnaire (Physical activity scale for elderly)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ACtotal
Time Frame: Day 0
|
Total activity count (AC) obtained from accelerometer
|
Day 0
|
|
EEtotal
Time Frame: Day 0
|
Total energy expenditure (EE) obtained from accelerometer
|
Day 0
|
|
PASE
Time Frame: Day 0
|
Physical Activity Score for Elderly (PASE)
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
AC moderate
Time Frame: Day 0
|
activity counts derived from accelerometer during moderate physical activity
|
Day 0
|
|
EE moderate
Time Frame: Day 0
|
energy expenditure obtained from accelerometer during moderate physical activity
|
Day 0
|
|
AC light
Time Frame: Day 0
|
activity counts derived from accelerometer during light physical activity
|
Day 0
|
|
EE light
Time Frame: Day 0
|
energy expenditure obtained from accelerometer during light physical activity
|
Day 0
|
|
AC vigorous
Time Frame: Day 0
|
activity counts derived from accelerometer during vigorous physical activity
|
Day 0
|
|
EE vigorous
Time Frame: Day 0
|
energy expenditure obtained from accelerometer during vigorous physical activity
|
Day 0
|
|
AC sedentary
Time Frame: Day 0
|
activity counts derived from accelerometer during sedentary physical activity
|
Day 0
|
|
EE sedentary
Time Frame: Day 0
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energy expenditure obtained from accelerometer during sedentary physical activity
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Day 0
|
|
step count
Time Frame: Day 0
|
total step count obtained from accelerometer
|
Day 0
|
|
Stroke Impact Scale
Time Frame: Day 0
|
Stroke Impact Scale
|
Day 0
|
|
Berg Balance Score
Time Frame: Day 0
|
Berg Balance Score
|
Day 0
|
|
Barthel Index for Activities of Daily Living
Time Frame: Day 0
|
Barthel Index for Activities of Daily Living
|
Day 0
|
|
FMA-UE
Time Frame: Day 0
|
The Fugl-Meyer Assessment for upper extremity
|
Day 0
|
|
FMA-LE
Time Frame: Day 0
|
The Fugl-Meyer Assessment for lower extremity
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Day 0
|
|
FMA-total
Time Frame: Day 0
|
The Fugl-Meyer Assessment total score
|
Day 0
|
|
Brunnstrom stage for proximal upper extremity
Time Frame: Day 0
|
Brunnstrom stage for proximal upper extremity
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Day 0
|
|
Brunnstrom stage for distal upper extremity
Time Frame: Day 0
|
Brunnstrom stage for distal upper extremity
|
Day 0
|
|
Brunnstrom stage for lower extremity
Time Frame: Day 0
|
Brunnstrom stage for lower extremity
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Day 0
|
|
FAS stage
Time Frame: Day 0
|
Functional Ambulation Scale (FAS) stage
|
Day 0
|
|
Mini Mental Test
Time Frame: Day 0
|
Mini Mental Test
|
Day 0
|
|
stroke duration
Time Frame: Day 0
|
stroke duration
|
Day 0
|
|
WA step width
Time Frame: Day 0
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Walk Across step width obtained from Neurocom forceplate
|
Day 0
|
|
WA step length
Time Frame: Day 0
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Walk Across step width obtained from Neurocom forceplate
|
Day 0
|
|
WA walking speed
Time Frame: Day 0
|
Walk Across walking speed obtained from Neurocom forceplate
|
Day 0
|
|
Modified Clinical Test of Sensory Interaction on Balance
Time Frame: Day 0
|
Modified Clinical Test of Sensory Interaction on Balance obtained from Neurocom forceplate
|
Day 0
|
|
LOS RT
Time Frame: Day 0
|
Limits of Stability reaction time obtained from Neurocom forceplate
|
Day 0
|
|
LOS VL
Time Frame: Day 0
|
Limits of Stability movement velocity obtained from Neurocom forceplate
|
Day 0
|
|
LOS EPE
Time Frame: Day 0
|
Limits of Stability endpoint excursion obtained from Neurocom forceplate
|
Day 0
|
|
LOS MXE
Time Frame: Day 0
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Limits of Stability maximum excursion obtained from Neurocom forceplate
|
Day 0
|
|
LOS DCL
Time Frame: Day 0
|
Limits of Stability directional control obtained from Neurocom forceplate
|
Day 0
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Danielsson A, Meirelles C, Willen C, Sunnerhagen KS. Physical activity in community-dwelling stroke survivors and a healthy population is not explained by motor function only. PM R. 2014 Feb;6(2):139-45. doi: 10.1016/j.pmrj.2013.08.593. Epub 2013 Aug 23.
- Lacroix J, Daviet JC, Borel B, Kammoun B, Salle JY, Mandigout S. Physical Activity Level Among Stroke Patients Hospitalized in a Rehabilitation Unit. PM R. 2016 Feb;8(2):97-104. doi: 10.1016/j.pmrj.2015.06.011. Epub 2015 Jun 21.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17.12.2018-242
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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