- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07652710
Relationship Between Balance, Arm Function and Body Awareness in People With Stroke
Investigation of Balance, Upper Extremity and Body Awareness in Individuals With Stroke
Stroke is one of the leading causes of long-term disability worldwide and is frequently associated with impairments in balance, upper extremity function, and body awareness. These impairments may negatively affect independence in activities of daily living and overall quality of life. Although previous studies have investigated the relationships between balance and upper extremity function after stroke, body awareness has received relatively limited attention.
The aim of this observational cross-sectional study is to investigate the relationship between balance, upper extremity skills, and body awareness in individuals with chronic stroke. Fifty-three individuals with chronic stroke will be recruited from the Department of Physical Medicine and Rehabilitation at Baskent University Hospital.
Balance will be assessed using the Berg Balance Scale and the Tetrax computerized posturography system. Upper extremity motor impairment and functional performance will be evaluated using the Fugl-Meyer Upper Extremity Assessment and the Wolf Motor Function Test. Body awareness will be assessed using the Body Awareness Questionnaire. Additional assessments will include lower extremity motor function, muscle tone, cognitive status, shoulder range of motion, and upper extremity reaction time.
The study is expected to provide a better understanding of the relationships among balance, upper extremity function, and body awareness in individuals with chronic stroke. The findings may contribute to the development of individualized rehabilitation strategies and improve clinical assessment approaches in stroke rehabilitation.
Study Overview
Status
Conditions
Detailed Description
Stroke is one of the leading causes of mortality and long-term disability worldwide and continues to represent a major public health problem. Motor, sensory, perceptual, and cognitive impairments that occur following stroke frequently result in limitations in functional independence and participation in daily life activities. Among these impairments, balance disorders and upper extremity dysfunction are particularly common and may significantly affect quality of life and rehabilitation outcomes.
Balance impairment after stroke is associated with postural instability, altered weight distribution, impaired trunk control, and an increased risk of falls. Changes in muscle tone, muscle weakness, impaired motor control, and deficits in sensory processing may negatively influence both static and dynamic balance. In addition, upper extremity impairments are observed in a large proportion of individuals with stroke and often persist into the chronic stage. Due to the complexity of upper extremity movements and the development of learned non-use, recovery of upper extremity function is generally slower and less complete than recovery of lower extremity function.
Previous studies have demonstrated associations between balance, trunk control, mobility, and upper extremity function in individuals with stroke. Impairments in upper extremity motor performance may influence postural control and balance strategies, while deficits in balance may limit functional use of the affected upper extremity. However, the interaction between these variables has not been fully clarified, particularly when functional upper extremity performance is evaluated using both clinical and objective measurement methods.
Body awareness has emerged as another important factor that may influence functional recovery following stroke. Body awareness is a multidimensional concept involving the perception and interpretation of bodily sensations, movements, and physiological states. It contributes to motor planning, movement execution, postural control, and interaction with the environment. Sensory deficits, perceptual disturbances, and motor impairments following stroke may negatively affect body awareness. Recent studies have suggested that body awareness may be associated with balance, walking ability, trunk control, upper extremity function, fear of falling, and independence in activities of daily living. Nevertheless, research examining body awareness in stroke populations remains limited.
A better understanding of the relationships among balance, upper extremity skills, and body awareness may provide valuable information for the development of individualized rehabilitation strategies. Identifying factors associated with functional performance may also contribute to the selection of appropriate assessment tools and treatment approaches in stroke rehabilitation.
The purpose of this observational cross-sectional study is to investigate the relationship between balance, upper extremity skills, and body awareness in individuals with chronic stroke. The study will be conducted at the Department of Physical Medicine and Rehabilitation, Baskent University Hospital. A total of 53 individuals with chronic stroke who meet the eligibility criteria will be included.
All assessments will be completed during a single evaluation session. Demographic and clinical information including age, sex, disease duration, dominant side, affected side, educational status, occupation, and use of assistive devices will be recorded.
Cognitive status will be assessed using the Standardized Mini-Mental State Examination (SMMSE), and only individuals scoring 24 points or higher will be included in the study. Muscle tone will be evaluated using the Modified Ashworth Scale, and only individuals with spasticity grades of 2 or 3 in the shoulder, elbow, wrist, and finger flexor muscles according to the Modified Ashworth Scale will be included in the study. Passive shoulder flexion range of motion will be measured using a goniometer, and only individuals with at least 120 degrees of shoulder flexion range of motion will be eligible for participation.
Upper and lower extremity motor impairment will be assessed using the Fugl-Meyer Assessment Scale. Upper extremity functional performance will be evaluated using the Wolf Motor Function Test.
Balance will be assessed using both clinical and objective measurement methods. Clinical balance performance will be evaluated using the Berg Balance Scale. Objective balance assessment will be performed using the Tetrax computerized posturography system, which provides measurements related to postural stability, weight distribution, and fall risk under different sensory conditions.
Upper extremity reaction time will be evaluated using the Light Trainer Flash Light Exercise System. Participants will be instructed to respond to randomly illuminated LED targets as quickly as possible, and the number of successful responses and reaction times will be recorded.
Body awareness will be assessed using the Body Awareness Questionnaire. Relationships among balance parameters, upper extremity motor and functional performance, reaction time, and body awareness scores will be analyzed using appropriate statistical methods.
Statistical analyses of the study data will be performed using SPSS software (Version 22.0). The obtained data will be expressed as mean ± standard deviation (x ± SD) and number (n%). Relationships among balance, upper extremity measurements, and body awareness will be evaluated using Pearson correlation analysis when data are normally distributed and Spearman rank correlation analysis when data are not normally distributed. In all analyses, the level of statistical significance will be accepted as p < 0.05.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Tuğba DÖRTBÖLÜK, BSc
- Phone Number: +90 554 678 39 28
- Email: dmrl_tugba@hotmail.com
Study Contact Backup
- Name: Zeliha Ozlem O Yuruk
- Phone Number: 1635 +90 312 246 66 66
- Email: bastug@baskent.edu.tr
Study Locations
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Ankara
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Ankara, Ankara, Turkey (Türkiye)
- Baskent University Hospital
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Principal Investigator:
- Zeliha Özlem YÜRÜK, Prof. Dr.
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Sub-Investigator:
- Münire KILINÇ, MD
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Contact:
- Zeliha Ozlem O Yuruk
- Phone Number: 1635 +90 312 246 66 66
- Email: bastug@baskent.edu.tr
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Contact:
- Tugba Dortboluk
- Phone Number: +90 554 678 39 28
- Email: dmrl_tugba@hotmail.com
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Principal Investigator:
- Tuğba DÖRTBÖLÜK, PT
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Individuals who experienced a cerebrovascular event at least 6 months previously
- Individuals between 18 and 75 years of age
- Individuals who have experienced stroke for the first time
- Individuals with shoulder, elbow, wrist, and finger muscle tone graded as 2 or 3 according to the Modified Ashworth Scale (MAS)
- Individuals scoring 24 points or higher on the Standardized Mini Mental State Examination
- Individuals with at least 120° of shoulder range of motion
- Individuals who are able to walk independently or with a walking aid
Exclusion Criteria:
- Presence of communication problems such as difficulties in reading, writing, or speaking
- Botulinum toxin injection within the last 3 months
- Presence of hemispatial neglect syndrome
- Presence of ataxia due to posterior circulation ischemia
- Bilateral involvement (bilateral hemiparesis)
- Having received physiotherapy within the last 6 months
- Presence of orthopedic problems such as shoulder subluxation, shoulder pain, contracture of the hand and wrist
- History of upper extremity or thoracic surgery
- Presence of stroke-related visual impairments (hemianopia)
- Presence of color blindness
- Use of antiepileptic medication
- History of convulsions
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Berg Balance Scale Score
Time Frame: Baseline (single assessment)
|
To assess balance performance, the Berg Balance Scale (BBS) will be used.
The scale consists of 14 functional tasks including sitting to standing, transfers, turning, reaching forward, picking up an object from the floor, and standing on one leg.
Each item is scored from 0 to 4. Total scores range from 0 to 56, with higher scores indicating better balance performance.
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Baseline (single assessment)
|
|
Tetrax Fall Index
Time Frame: Baseline (single assessment)
|
To assess fall risk the Tetrax Computerized Posturography System will be used.
Measurements will be performed under eight different sensory conditions.
The Fall Index ranges from 0 to 100, with higher scores indicating a greater risk of falling.
|
Baseline (single assessment)
|
|
Eyes Open Stability Index
Time Frame: Baseline (single assessment)
|
To assess postural stability under eyes-open conditions, the Tetrax Computerized Posturography System will be used.
The Stability Index obtained during the normal standing position with eyes open will be recorded.
Higher values indicate poorer postural stability.
|
Baseline (single assessment)
|
|
Eyes Closed Stability Index
Time Frame: Baseline (single assessment)
|
To assess postural stability without visual input, participants will stand on the Tetrax Computerized Posturography System with their eyes closed.
The Stability Index obtained during this condition will be recorded.
Higher values indicate poorer postural stability.
|
Baseline (single assessment)
|
|
Weight Distribution Index
Time Frame: Baseline (single assessment)
|
To assess weight distribution during standing, the Tetrax Computerized Posturography System will be used.
The Weight Distribution Index will be recorded.
Higher values indicate greater asymmetry in weight distribution between the supporting surfaces.
|
Baseline (single assessment)
|
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Fugl-Meyer Upper Extremity Assessment Score
Time Frame: Baseline (single assessment)
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To assess upper extremity motor impairment, the Fugl-Meyer Upper Extremity Assessment will be used.
The scale evaluates reflex activity, voluntary movement, coordination, and speed.
Scores range from 0 to 66, with higher scores indicating better upper extremity motor function.
|
Baseline (single assessment)
|
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Wolf Motor Function Test Functional Ability Score
Time Frame: Baseline (single assessment)
|
Upper extremity functional ability will be assessed using the Functional Ability Scale of the Wolf Motor Function Test (WMFT).
Fifteen functional tasks will be evaluated and scored on a scale from 0 to 5, with higher scores indicating better upper extremity function.
|
Baseline (single assessment)
|
|
Wolf Motor Function Test Performance Time
Time Frame: Baseline (single assessment)
|
Upper extremity motor performance will be assessed using the Wolf Motor Function Test (WMFT).
The average time required to complete the 15 functional tasks will be recorded in seconds.
Shorter completion times indicate better upper extremity performance.
|
Baseline (single assessment)
|
|
Body Awareness Questionnaire Score
Time Frame: Baseline (single assessment)
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To assess body awareness, the Body Awareness Questionnaire will be used.
The questionnaire consists of 18 items evaluating awareness of bodily processes and reactions.
Total scores range from 18 to 126, with higher scores indicating greater body awareness.
|
Baseline (single assessment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Upper Extremity Reaction Time
Time Frame: Baseline (single assessment)
|
Upper extremity reaction time will be assessed using the Light Trainer Flash Light Exercise System.
Participants will be instructed to deactivate illuminated LED targets as quickly as possible during a 60-second test.
The average time required to deactivate the illuminated targets will be recorded.
Shorter reaction times indicate better performance.
|
Baseline (single assessment)
|
|
Fugl-Meyer Lower Extremity Assessment Score
Time Frame: Baseline (single assessment)
|
Lower extremity motor function will be assessed using the Fugl-Meyer Lower Extremity Assessment.
The scale consists of 17 items evaluating movement, coordination, and motor performance of the lower extremity.
Total scores range from 0 to 34, with higher scores indicating better lower extremity motor function.
|
Baseline (single assessment)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zeliha Özlem O YÜRÜK, Baskent University Hospital, Department of Physical Medicine and Rehabilitation
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- KA26/39
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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