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Not yet recruiting NCT07652710

Relationship Between Balance, Arm Function and Body Awareness in People With Stroke

Observational Chronic Stroke Patient

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Chronic Stroke Patient. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Investigation of Balance, Upper Extremity and Body Awareness in Individuals With Stroke

Overview

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.

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.

Primary outcome measures

  • Berg Balance Scale Score [Time frame: Baseline (single assessment)]
  • Tetrax Fall Index [Time frame: Baseline (single assessment)]
  • Eyes Open Stability Index [Time frame: Baseline (single assessment)]
  • Eyes Closed Stability Index [Time frame: Baseline (single assessment)]
  • Weight Distribution Index [Time frame: Baseline (single assessment)]
  • Fugl-Meyer Upper Extremity Assessment Score [Time frame: Baseline (single assessment)]
  • Wolf Motor Function Test Functional Ability Score [Time frame: Baseline (single assessment)]
  • Wolf Motor Function Test Performance Time [Time frame: Baseline (single assessment)]
  • Body Awareness Questionnaire Score [Time frame: Baseline (single assessment)]
Secondary outcome measures (2)
  • Upper Extremity Reaction Time [Time frame: Baseline (single assessment)]
  • Fugl-Meyer Lower Extremity Assessment Score [Time frame: Baseline (single assessment)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Turkey (Türkiye) · 1 center
  • Baskent University Hospital — Ankara

Identifiers

NCT: NCT07652710 · KA26/39

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗