HemiplegiaNCT06181877
Deep Trunk Muscle Activation and Balance in Post-Stroke Hemiplegia
An observational study of Hemiplegia, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hemiplegia
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 31 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of 36 adult patients diagnosed with post-stroke hemiplegia. Participants were selected from patients receiving inpatient or outpatient rehabilitation at a single tertiary training and research hospital, according to specific functional and clinical eligibility criteria
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Cerebellar sequelae
- Vestibular balance disorders (e.g., vertigo)
- Parkinson's disease
- Balance impairments due to visual deficits
- Pre-stroke balance disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Training & Research Hospital
Istanbul
About this study
Official title: The Effect of Lumbar Multifidus and Transversus Abdominis Muscle Activation on Balance in Patients With 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.
Read the detailed description
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.
- Conditions
- Hemiplegia
- Keywords
- hemiplegia, transversus abdominis, multifidus, balance, stroke
- Medical subject headings
- Hemiplegia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hemiplegic Patients | Patients with hemiplegia after stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale (BBS)
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.
Measured: Baseline (Single assessment on the same day as the ultrasonographic evaluation)
Postural Assessment Scale for Stroke Patients - Total Score (PASS-Total)
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.
Measured: Baseline (Single assessment on the same day as the ultrasonographic evaluation)
Postural Assessment Scale for Stroke Patients - Maintaining a Posture Subscale (PASS-MP)
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.
Measured: Baseline (Single assessment on the same day as the ultrasonographic evaluation)
Postural Assessment Scale for Stroke Patients - Changing a Posture Subscale (PASS-CP)
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.
Measured: Baseline (Single assessment on the same day as the ultrasonographic evaluation)
Secondary outcomes (7)
Brunnstrom Stages of Recovery (BRS)
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.
Measured: Baseline (Single assessment on the same day as the ultrasonographic evaluation)
Paretic-Side Transversus Abdominis Thickening Fraction (TF)
([Contraction Thickness - Resting Thickness] / Resting Thickness) x 100
Unit of Measure: Percentage (%)
Measured: Baseline (concurrent with clinical balance and motor evaluations)
Transversus Abdominis Resting Thickness Ratio (RTR)
(Paretic Resting Thickness / Non-paretic Resting Thickness) x 100
Unit of Measure: Percentage (%)
Measured: Baseline (concurrent with clinical balance and motor evaluations)
Transversus Abdominis Thickening Fraction Ratio (TFR)
(Paretic Thickening Fraction / Non-paretic Thickening Fraction) x 100
Unit of Measure: Percentage (%)
Measured: Baseline (concurrent with clinical balance and motor evaluations)
Paretic-Side Lumbar Multifidus Thickening Fraction (TF)
([Contraction Thickness - Resting Thickness] / Resting Thickness) x 100
Unit of Measure: Percentage (%)
Measured: Baseline (concurrent with clinical balance and motor evaluations)
Lumbar Multifidus Resting Thickness Ratio (RTR)
(Paretic Resting Thickness / Non-paretic Resting Thickness) x 100
Unit of Measure: Percentage (%)
Measured: Baseline (concurrent with clinical balance and motor evaluations)
Lumbar Multifidus Thickening Fraction Ratio (TFR)
(Paretic Thickening Fraction / Non-paretic Thickening Fraction) x 100
Unit of Measure: Percentage (%)
Measured: Baseline (concurrent with clinical balance and motor evaluations)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start1 Feb 2023
- Primary completion1 Sep 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies 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.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nazlı Derya Bugdayci, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- NAZLI DERYA BUGDAYCI, MD, Principal investigator, Istanbul Physical Therapy Rehabilitation Training & Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181877
- Sponsor's protocol ID
- IstanbulPMRTRH-2023-ELMTRABH
- Status last verified
- May 2026
- First submitted
- 13 Dec 2023
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lumbar Multifidus and Transversus Abdominis Muscle Activation on Balance in Patients With Hemiplegia
- ClinicalTrials.gov ID
- NCT06181877
- Acronym / sponsor ID
- IstanbulPMRTRH-2023-ELMTRABH
- Conditions
- Hemiplegia
- Keywords
- hemiplegia, transversus abdominis, multifidus, balance, stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 26 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemiplegic Patients | – | –Patients with hemiplegia after stroke |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of 36 adult patients diagnosed with post-stroke hemiplegia. Participants were selected from patients receiving inpatient or outpatient rehabilitation at a single tertiary training and research hospital, according to specific functional and clinical eligibility criteria
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
7 secondary outcomes
Brunnstrom Stages of Recovery (BRS)
Time frame: Baseline (Single assessment on the same day as the ultrasonographic evaluation)
Paretic-Side Transversus Abdominis Thickening Fraction (TF)
Time frame: Baseline (concurrent with clinical balance and motor evaluations)
Transversus Abdominis Resting Thickness Ratio (RTR)
Time frame: Baseline (concurrent with clinical balance and motor evaluations)
Transversus Abdominis Thickening Fraction Ratio (TFR)
Time frame: Baseline (concurrent with clinical balance and motor evaluations)
Paretic-Side Lumbar Multifidus Thickening Fraction (TF)
Time frame: Baseline (concurrent with clinical balance and motor evaluations)
Lumbar Multifidus Resting Thickness Ratio (RTR)
Time frame: Baseline (concurrent with clinical balance and motor evaluations)
Lumbar Multifidus Thickening Fraction Ratio (TFR)
Time frame: Baseline (concurrent with clinical balance and motor evaluations)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
Related trials for Hemiplegia
Not yet recruiting
Effects of Upper Extremity Physiotherapy and Home Exercises on Functional Outcomes in Individuals With Stroke
Stroke
Recruiting
Task-Oriented Training Versus High-Intensity Gait Training in People With Chronic Stroke
Stroke, Hemiplegia
Active, not recruitingObservational study
Studies of the Variable Phenotypic Presentations of Rapid-Onset Dystonia Parkinsonism and Other Movement Disorders
Dystonia, Parkinsonism
RecruitingObservational study
Post-Stroke Apraxia, Motor Function, Balance, and Gait
Stroke, Ideomotor Apraxia
RecruitingObservational study
Ideomotor Apraxia and Robotic Gait Rehabilitation Outcomes After Stroke
Stroke, Ideomotor Apraxia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
NAZLI DERYA BUGDAYCI, MD principal investigator
Istanbul Physical Therapy Rehabilitation Training & Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemiplegia, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (BBS) (time frame: Baseline (Single assessment on the same day as the ultrasonographic evaluation)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.