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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 75 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Study population: Individuals aged 18-75 years with ischemic or hemorrhagic stroke who applied to Kırıkkale University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation will be included in our study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Investigation Of The Relationship Between Spinal Straightness And Posture And Balance, Physical Performance And Energy Consumption In Individuals With Stroke

Conditions

Stroke, Postural; Defect, Energy Supply; Deficiency

Being tested

use of spinal mouse, Brunnstrom's Hemiplegia Recovery Staging, The six minute walking test (6MWT), Functional Reach Test (FRT), Mini Balance Evaluation Systems Test (Mini-BESTest)

Keywords

stroke,posture,balance,spinal straightness

Medical subject headings

Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• use of spinal mouseDevice

  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 StagingDiagnostic test

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

• The six minute walking test (6MWT)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)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)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)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)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 SymmetryDiagnostic 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 angleDiagnostic 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Use of Spinal Mouse

   The SM device is started at the 7th cervical vertebra and advanced to the anal line. During the measurement, the mouse is lowered from the skin surface at a constant speed from top to bottom at the midpoint of the processus spinosus. Individuals are asked to assume the upright, maximal flexion, maximal extension positions in sequence.

   The relevant parameters in each position are thoracic curvature angle, lumbar curvature angle, sacrum-hip angle, tilt angle, mobility assessment (from extension to flexion position). The data transferred by the SM device to the computer via Bluetooth is analyzed and the angular deviation between each vertebra is calculated by the SM software as an angle value. The raw data of the wireless and handheld mouse is transferred to the computer via bluetooth and the data is analyzed by the SM software.

   Measured: day 1

2. Postural Symmetry Index

   A form of measurement in which two scales are used to calculate the weight transferred to the intact and paralyzed limb. The values obtained as a result of the test are calculated with the following formulas. In this index, percentages close to 0 define equal symmetry and good postural control while standing, while higher percentages define asymmetry and poor postural control. Postural Symmetry (%) = Weight on Paralytic Side / Body Weight - 0.5| x 100 Weight Transfer Symmetry = Weight on Intact Side - Weight on Paralytic Side (%) Total Body Weight.

   Measured: day 1

3. The Postural Assessment Scale (PASS)

   The PASS contains 12 items that measure a person's balance performance in situations of varying difficulty, such as lying, sitting, standing or changing standing position. The scale is administered under two main headings: during posture maintenance and posture change. Sitting without support, standing with support, standing without support, standing on paretic and nonparetic legs are the balance assessments under the heading of maintaining posture. Lateral rotation from supine to paretic and nonparetic side, lateral rotation from supine to sitting, from sitting to supine, from sitting to supine, from sitting to supine, from sitting to standing, from standing to sitting, and picking up a pen on the floor while standing are balance assessments under the heading of posture change. The scale is evaluated between 0-36. The feasibility of the movement is tested between 0-3; "0" is the lowest value; "3" is the highest value

   Measured: day 1

4. MINI-BEST TEST

   Mini-BEST Test will be used to determine balance level. It consists of 4 sub-parameters including preparatory movement, reactive postural control, sensory orientation, dynamic walking and a total of 14 items. It is a test that is evaluated over a total of 28 points and requires an average of 10-15 minutes. High score indicates high function

   Measured: day 1

5. Functional reach test (FRT)

   It is used to measure both the individual's functional balance and the amount of dynamic reaching. Patients will first be asked to extend their arm straight forward and the distance they reach will be recorded. They will then be asked to reach as far as they can reach forward without lifting their heels off the floor. The maximum value at which he/she can reach and return to his/her original position without losing his/her balance will be measured. Repeating 3 times, these three values will be averaged

   Measured: day 1

6. Timed Up and Go Test (TUG)

   The timed stand and walk test (STWT) is used to assess timed performance. In the application, the individual first gets up from the chair, walks 3 meters, then walks back to the same chair and sits down again. The patient's time to complete the test is measured with a stopwatch. Measuring the time taken during this performance is used to determine the functional mobility of the person. Accordingly, completing the task in ≤ 10 seconds indicates that functional mobility is normal, completing the task in 10-20 seconds indicates that mobility is good, the person can walk with or without a device, can go out alone, completing the task in 20-30 seconds indicates that there is a serious problem with mobility and that the person performs mobility using an assistive device.

   Measured: day 1

7. 6 Minute Walk Test(6MWT)

   6 Minute Walk Test (6MWT): Physiological expenditure index (PEI) will be calculated to evaluate the energy expenditure and walking effort of individuals during the test. During the test, individuals will be asked to walk as fast as possible in a 30-meter straight corridor. Individuals will be told that if they feel tired or breathless during the test, they can rest or stop the test. Standard words of encouragement are used during the test. At the end of the test, the 6MWT distance is recorded in meters. Using age and gender, 6MWT expected values and 6MWT distance (% 6MWT) values expressed as a percentage of the expected values (6MWT distance * Body weight (kg)) are calculated. A 6MWT distance of less than 82% indicates a reduced functional capacity

   Measured: day 1

8. The Five Times Sit to Stand Test (5xSTS)

   For the test, the individual is asked to sit on a chair with a height of 43.18 (12 inches) cm with the back straight, feet in contact with the floor and arms crossed on the chest. The individual is asked to sit on and stand up from the chair 1 time for a trial. After the trial performance, he/she is instructed to sit on the chair and stand up as quickly as possible and without stopping, and the elapsed time at the end of the fifth repetition is recorded. Validity and reliability studies were conducted in individuals with stroke 20-29 yrs ⇒ 6.0±1.4 sec 30-39 yrs ⇒ 6.1±1.4 sec 40-49 yrs ⇒ 7.6±1.8 sec 50-59 yrs ⇒ 7.7±2.6 sec 60-69 yrs ⇒ 8.4±0.0 sec (male), 12.7±1.8 sec (female) 70-79 yrs ⇒ 11.6±3.4 sec (male), 13.0±4.8 sec (female) 80-89 yrs ⇒ 16.7±4.5 sec (male), 17.2±5.5 sec (female) 90+ yrs ⇒ 19.5±2.3 sec (male), 22.9±9.6 sec (female)

   Measured: day 1

9. 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.

   Measured: day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted21 Nov 2024
2. Study start5 Mar 2024
3. Primary completion18 Jun 2025 (estimated)
4. Study completion5 Jul 2025 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for StrokeStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.