NCT06181877

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 13, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 26, 2023

Completed
Last Updated

June 1, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

December 13, 2023

Last Update Submit

May 29, 2026

Conditions

Keywords

hemiplegiatransversus abdominismultifidusbalancestroke

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

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

Secondary Outcomes (7)

  • Brunnstrom Stages of Recovery (BRS)

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

  • Paretic-Side Transversus Abdominis Thickening Fraction (TF)

    Baseline (concurrent with clinical balance and motor evaluations)

  • Transversus Abdominis Resting Thickness Ratio (RTR)

    Baseline (concurrent with clinical balance and motor evaluations)

  • Transversus Abdominis Thickening Fraction Ratio (TFR)

    Baseline (concurrent with clinical balance and motor evaluations)

  • Paretic-Side Lumbar Multifidus Thickening Fraction (TF)

    Baseline (concurrent with clinical balance and motor evaluations)

  • +2 more secondary outcomes

Study Arms (1)

Hemiplegic Patients

Patients with hemiplegia after stroke

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training & Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

HemiplegiaStroke

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • NAZLI DERYA BUGDAYCI, MD

    Istanbul Physical Therapy Rehabilitation Training & Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 13, 2023

First Posted

December 26, 2023

Study Start

February 1, 2023

Primary Completion

September 1, 2023

Study Completion

October 31, 2023

Last Updated

June 1, 2026

Record last verified: 2026-05

Locations