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Completed

NCT Number: NCT06181877

Deep Trunk Muscle Activation and Balance in Post-Stroke Hemiplegia

Patients with post-stroke hemiplegia frequently exhibit balance impairments driven by multiple pathophysiological mechanisms. Although the role of core musculature in maintaining normal posture and balance is well established, and the benefits of core stabilization exercises have been documented, further research is needed on individual muscle contributions.

Therefore, this study aimed to investigate the specific impact of bilateral transversus abdominis and bilateral lumbar multifidus muscles on balance performance in patients with stroke-related hemiplegia.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Physical Medicine Rehabilitation Training & Research Hospital

Istanbul, Turkey (Türkiye)

About this study

Trunk muscle dysfunction in stroke patients leads to both balance impairments and excessive compensatory effort to maintain postural control. While some patients completely lose their ambulation ability due to stroke, others experience increased postural sway and impaired balance, which elevate the fear and risk of falling. Previous studies have demonstrated a significant relationship between static balance, duration of hospital stay, and post-stroke functional abilities. Furthermore, early-stage trunk muscle control has been shown to be a strong predictor of activities of daily living within the first six months post-stroke. Although numerous studies have proven the efficacy of core stabilization exercises on balance and functional outcomes in hemiplegic patients, data on individual deep muscle dynamics remain limited.

Therefore, this cross-sectional study aimed to investigate the relationship between ultrasound-measured bilateral transversus abdominis and bilateral lumbar multifidus muscle values and balance performance in patients with hemiplegia. The study population consists of adult patients diagnosed with post-stroke hemiplegia who underwent clinical and ultrasonographic evaluations. Participants are selected from patients receiving inpatient or outpatient rehabilitation at a single tertiary training and research hospital, according to specific functional and clinical eligibility criteria using a non-probability convenience sampling method.

To standardize the ultrasonographic measurements and minimize inter-individual variations, specific muscle parameters are calculated and integrated into the statistical analyses:

Paretic Thickening Fraction (TF) = ([Contraction Thickness - Resting Thickness] / Resting Thickness) x 100,

Resting Thickness Ratio (RTR) = (Paretic Resting Thickness / Non-paretic Resting Thickness) x 100,

Thickening Fraction Ratio (TFR) = (Paretic Thickening Fraction / Non-paretic Thickening Fraction) x 100.

Statistical analyses will be performed to evaluate the relationships between these muscle parameters and clinical balance scores. Initially, correlation analyses will be performed between the dependent and independent variables to identify potential predictors. Subsequently, hierarchical linear regression analyses will be conducted to evaluate the specific impact of muscle values on balance outcomes. In these models, confounding control variables will be entered in the first block (Block 1) to adjust for baseline characteristics. The muscle parameters that demonstrated significant correlations in the initial analysis will be entered in the second block (Block 2). This hierarchical approach will allow for the determination of the incremental variance explained by deep trunk muscle dynamics on postural balance performance, over and above the control variables. A p-value of less than 0.05 will be considered statistically significant.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-65 years
  • At least 1 month post stroke
  • History of unilateral stroke
  • Ability to cooperate cognitively
  • Ability to maintain balance while sitting without support and/or balance while standing with or without support
  • BMI < 30 kg/m²

Exclusion criteria

  • History of hemiplegia on the opposite side of the body
  • Diagnosis of extruded or sequestrated lumbar herniation and/or a history of lumbar surgery
  • History of lumbar vertebral fracture
  • Traumatic brain injury
  • Neuromuscular disorders that may cause muscle atrophy
  • Sensory deficits
  • Cerebellar sequelae
  • Vestibular balance disorders (e.g., vertigo)
  • Parkinson's disease
  • Balance impairments due to visual deficits
  • Pre-stroke balance disorders

Treatment and study plan

Primary outcomes

  1. Berg Balance Scale (BBS)

    Time frame: Baseline (Single assessment on the same day as the ultrasonographic evaluation)

    The Berg Balance Scale (BBS) is a 14-item objective clinical measure designed to assess static and dynamic balance performance in post-stroke patients. Items include tasks ranging from sitting unsupported to standing on one leg. Each item is scored on a 5-point ordinal scale from 0 (lowest function/cannot perform) to 4 (highest function/independent performance). The total score ranges from 0 to 56, with higher scores indicating better functional balance and postural control.

  2. Postural Assessment Scale for Stroke Patients - Total Score (PASS-Total)

    Time frame: Baseline (Single assessment on the same day as the ultrasonographic evaluation)

    The total score of the Postural Assessment Scale for Stroke Patients (PASS) is obtained by summing the scores of all 12 items across both subscales (5 items for Maintaining a Posture and 7 items for Changing a Posture). Each item is scored from 0 to 3, resulting in a total score ranging from 0 to 36. Higher total scores indicate a higher level of comprehensive postural control, encompassing both static stability and dynamic mobility in stroke patients.

  3. Postural Assessment Scale for Stroke Patients - Maintaining a Posture Subscale (PASS-MP)

    Time frame: Baseline (Single assessment on the same day as the ultrasonographic evaluation)

    This subscale evaluates the patient's ability to maintain a given posture across 5 specific items. Each item is scored from 0 (cannot perform) to 3 (can perform for a sustained period), with a subscale total score ranging from 0 to 15. Higher scores indicate better postural maintenance.

  4. Postural Assessment Scale for Stroke Patients - Changing a Posture Subscale (PASS-CP)

    Time frame: Baseline (Single assessment on the same day as the ultrasonographic evaluation)

    This subscale assesses the patient's ability to change posture across 7 specific items. Each item is scored from 0 to 3, with a subscale total score ranging from 0 to 21. Higher scores indicate greater mobility and transition capability.

Secondary outcomes

  1. Brunnstrom Stages of Recovery (BRS)

    Time frame: Baseline (Single assessment on the same day as the ultrasonographic evaluation)

    Brunnstrom Stages of Recovery is a clinical classification system used to evaluate the sequential stages of motor recovery and synergy patterns in post-stroke hemiplegic patients. Motor recovery is independently assessed for the upper extremity (BRS-UE), hand (BRS-Hand), and lower extremity (BRS-LE) across 6 distinct stages (Stage 1: Flaccidity to Stage 6: Normal).

    However, BRS-Hand was excluded from the analyses for two reasons:

    • The strong correlation between BRS-UE and BRS-Hand poses a high risk of multicollinearity in regression models.
    • Literature indicates upper body motor status is widely represented by BRS-UE, whereas the hand influences balance primarily through somatosensory perception rather than distal motor function.

    Therefore, only BRS-UE and BRS-LE scores were integrated into the correlation and regression models.

  2. Paretic-Side Transversus Abdominis Thickening Fraction (TF)

    Time frame: Baseline (concurrent with clinical balance and motor evaluations)

    ([Contraction Thickness - Resting Thickness] / Resting Thickness) x 100

    Unit of Measure: Percentage (%)

  3. Transversus Abdominis Resting Thickness Ratio (RTR)

    Time frame: Baseline (concurrent with clinical balance and motor evaluations)

    (Paretic Resting Thickness / Non-paretic Resting Thickness) x 100

    Unit of Measure: Percentage (%)

  4. Transversus Abdominis Thickening Fraction Ratio (TFR)

    Time frame: Baseline (concurrent with clinical balance and motor evaluations)

    (Paretic Thickening Fraction / Non-paretic Thickening Fraction) x 100

    Unit of Measure: Percentage (%)

  5. Paretic-Side Lumbar Multifidus Thickening Fraction (TF)

    Time frame: Baseline (concurrent with clinical balance and motor evaluations)

    ([Contraction Thickness - Resting Thickness] / Resting Thickness) x 100

    Unit of Measure: Percentage (%)

  6. Lumbar Multifidus Resting Thickness Ratio (RTR)

    Time frame: Baseline (concurrent with clinical balance and motor evaluations)

    (Paretic Resting Thickness / Non-paretic Resting Thickness) x 100

    Unit of Measure: Percentage (%)

  7. Lumbar Multifidus Thickening Fraction Ratio (TFR)

    Time frame: Baseline (concurrent with clinical balance and motor evaluations)

    (Paretic Thickening Fraction / Non-paretic Thickening Fraction) x 100

    Unit of Measure: Percentage (%)

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study title

The Effect of Lumbar Multifidus and Transversus Abdominis Muscle Activation on Balance in Patients With Hemiplegia

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 26, 2023
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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