Spinal Straightness, Posture And Balance, Physical Performance And Energy Consumption In Individuals With Stroke

NCT ID: NCT06699381

Last Updated: 2025-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-05

Study Completion Date

2025-07-05

Brief Summary

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Patients diagnosed with ischemic or hemorrhagic stroke who applied to Kırıkkale University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation will be included in the study. The aim of our study is to investigate the relationship between spinal alignment, posture and weight transfer symmetry with balance, physical performance and energy expenditure in stroke patients.

Detailed Description

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Patients diagnosed with ischemic or hemorrhagic stroke who applied to Kırıkkale University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation will be included in the study. The number of patients to be included in our study will be determined by power analysis.

Sociodemographic information (Age, Gender, Body Mass Index, Dominant Side) of the individuals included in the study will be recorded.

Information about the stroke (cause of stroke, time elapsed since stroke, side of involvement, neglect after stroke, comorbidities, history of falls in the last six months and 1 year, use of assistive devices, etc.) will be recorded.

1. Motor assessment The motor level of the individuals will be assessed according to the Brunnstrom Assessment. Upper and lower extremities will be evaluated separately.
2. Posture assessment Within the scope of the posture assessment of the individuals, Spinal Mouse, a computer-aided device, will be used for spinal alignment, and Postural Symmetry Index and Weight Transfer Symmetry will be calculated.
3. Balance Trunk control will be assessed with the Postural Assessment Scale for Stroke Patients (PASS), standing balance will be assessed with the Minibestest, Functional reach test (FUT) and timed get up and walk test (ZKTY)
4. Physical performance assessment Six-minute walk test and 5 times sit and stand test will be used to evaluate physical performance. In addition, physiologic energy expenditure index will be calculated during the six-minute walk test.

When we examine the literature, there are many separate studies on the alignment of the pelvis after stroke, weight transfer symmetry, postural control and energy consumption of individuals with stroke. However, there is a lack of studies on spinal alignment in stroke patients in general. Therefore, the aim of this study was to investigate the relationship between spinal alignment, posture and weight transfer symmetry with balance, physical performance and energy expenditure in stroke patients.

Conditions

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Stroke Postural; Defect Energy Supply; Deficiency

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Stroke

Descriptive research

use of spinal mouse

Intervention Type DEVICE

Spinal Mouse (SM) is an external non-invasive measurement device that evaluates the spinal angle and shape in the frontal and sagittal planes

Brunnstrom's Hemiplegia Recovery Staging

Intervention Type DIAGNOSTIC_TEST

According to Brunnstrom's stages of recovery, the individual will be identified at which stage

The six minute walking test (6MWT)

Intervention Type DIAGNOSTIC_TEST

It evaluates the functional capacity of the individual and it provides valuable information regarding all the systems during physical activity, including pulmonary and cardiovascular systems, blood circulation, neuromuscular units, body metabolism, and peripheral circulation

Functional Reach Test (FRT)

Intervention Type DIAGNOSTIC_TEST

Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in in simple task.

In standing, measures the distance between the length of an outstretched arm in a maximal forward reach, while maintaining a fixed base of support.

This information is correlated with risk of falling A number of factors exert a major influence on this evaluation: Research revealed that movement strategy and reduced spinal flexibility both affect reach distance.

Mini Balance Evaluation Systems Test (Mini-BESTest)

Intervention Type DIAGNOSTIC_TEST

This test measures dynamic balance, functional mobility, and gait. It is commonly used in populations who have or have had multiple sclerosis (MS), Parkinson disease (PD), strokes, spinal cord injury (SCI), or cancer.

The Mini-BESTest was developed in 2010 from the Balance Evaluation Systems Test (BESTest), then revised in 2013 to clarify inconsistencies in scoring. The scoring instructions were different in the published and online versions. The revision clarified that the Mini-BESTest should be scored out of 28 points. Explanations for how to score items 3, 6, and 14 were also given.

The Mini-BESTest consists of 14 items, including 4 of the 6 sections (anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait) from the BESTest.

The five Times Sit to Stand Test (5x Sit-To-Stand Test)

Intervention Type DIAGNOSTIC_TEST

It's used to asses functional lower limbs strength, transitional movements, balance, and fall risk in older adults.

The Postural Assessment Scale for Stroke (PASS)

Intervention Type DIAGNOSTIC_TEST

The Postural Assessment Scale for Stroke (PASS) is an outcome measure specifically designed to assess and monitor postural control after stroke. It was developed in 1999 as an adaptation of the Fugl-Meyer Assessment balance subscale\[1\]. It contains 12 four-level items of varying difficulty for assessing ability to maintain or change a given lying, sitting or standing posture

Postural Symmetry Index and Weight Transfer Symmetry

Intervention Type DIAGNOSTIC_TEST

It is a form of measurement in which two scales are used to calculate the weight transferred to the intact and stroke limb. The values obtained as a result of the test are calculated with formulas.

Measurement of the craniovertebral angle

Intervention Type DIAGNOSTIC_TEST

Measurement of the craniovertebral angle; the patient is asked to find the most natural position by flexion and extension of the head in the standing position and a photograph is taken with a digital camera from a distance of 1.5 m to the shoulder level of the patient and this process is repeated 3 times. The images obtained are then digitally calculated with the help of an appropriate program.

Interventions

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use of spinal mouse

Spinal Mouse (SM) is an external non-invasive measurement device that evaluates the spinal angle and shape in the frontal and sagittal planes

Intervention Type DEVICE

Brunnstrom's Hemiplegia Recovery Staging

According to Brunnstrom's stages of recovery, the individual will be identified at which stage

Intervention Type DIAGNOSTIC_TEST

The six minute walking test (6MWT)

It evaluates the functional capacity of the individual and it provides valuable information regarding all the systems during physical activity, including pulmonary and cardiovascular systems, blood circulation, neuromuscular units, body metabolism, and peripheral circulation

Intervention Type DIAGNOSTIC_TEST

Functional Reach Test (FRT)

Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in in simple task.

In standing, measures the distance between the length of an outstretched arm in a maximal forward reach, while maintaining a fixed base of support.

This information is correlated with risk of falling A number of factors exert a major influence on this evaluation: Research revealed that movement strategy and reduced spinal flexibility both affect reach distance.

Intervention Type DIAGNOSTIC_TEST

Mini Balance Evaluation Systems Test (Mini-BESTest)

This test measures dynamic balance, functional mobility, and gait. It is commonly used in populations who have or have had multiple sclerosis (MS), Parkinson disease (PD), strokes, spinal cord injury (SCI), or cancer.

The Mini-BESTest was developed in 2010 from the Balance Evaluation Systems Test (BESTest), then revised in 2013 to clarify inconsistencies in scoring. The scoring instructions were different in the published and online versions. The revision clarified that the Mini-BESTest should be scored out of 28 points. Explanations for how to score items 3, 6, and 14 were also given.

The Mini-BESTest consists of 14 items, including 4 of the 6 sections (anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait) from the BESTest.

Intervention Type DIAGNOSTIC_TEST

The five Times Sit to Stand Test (5x Sit-To-Stand Test)

It's used to asses functional lower limbs strength, transitional movements, balance, and fall risk in older adults.

Intervention Type DIAGNOSTIC_TEST

The Postural Assessment Scale for Stroke (PASS)

The Postural Assessment Scale for Stroke (PASS) is an outcome measure specifically designed to assess and monitor postural control after stroke. It was developed in 1999 as an adaptation of the Fugl-Meyer Assessment balance subscale\[1\]. It contains 12 four-level items of varying difficulty for assessing ability to maintain or change a given lying, sitting or standing posture

Intervention Type DIAGNOSTIC_TEST

Postural Symmetry Index and Weight Transfer Symmetry

It is a form of measurement in which two scales are used to calculate the weight transferred to the intact and stroke limb. The values obtained as a result of the test are calculated with formulas.

Intervention Type DIAGNOSTIC_TEST

Measurement of the craniovertebral angle

Measurement of the craniovertebral angle; the patient is asked to find the most natural position by flexion and extension of the head in the standing position and a photograph is taken with a digital camera from a distance of 1.5 m to the shoulder level of the patient and this process is repeated 3 times. The images obtained are then digitally calculated with the help of an appropriate program.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Individuals between the ages of 18-75 years diagnosed with stroke
* Volunteering to participate in the study
* Diagnosis of hemorrhagic or ischemic stroke,
* No collaboration and communication problems
* Can walk with assistive device or independently

Exclusion Criteria

* Have another neurological, cardiopulmonary or orthopedic problem other than stroke that may affect functionality, ambulation and balance
* Patients who refused to participate in the study and did not give written consent.
* Cooperation and communication problems were determined as
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kırıkkale University

OTHER

Sponsor Role lead

Responsible Party

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Saniye Aydoğan Arslan

assoc. prof. dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Saniye Arslan, Assoc.Prof.

Role: PRINCIPAL_INVESTIGATOR

Kırıkkale University

Serhat Ceylan, PT, MSc.

Role: PRINCIPAL_INVESTIGATOR

Kırıkkale University

Locations

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Kırıkkale University

Kırıkkale, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Saniye Arslan, Assoc.Prof.

Role: CONTACT

+90 5053333457

Serhat Ceylan, PT, MSc.

Role: CONTACT

+90 5380391432

Facility Contacts

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Saniye Aydoğan arslan, Assoc. Prof

Role: primary

Other Identifiers

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KirikkaleU-SCEYLAN-001

Identifier Type: -

Identifier Source: org_study_id

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