NCT06181877

Brief Summary

Patients with post-stroke hemiplegia may develop balance disorder and limitation in ambulation ability due to multiple mechanisms. The effects of core muscles on maintaining normal posture, balance and ambulation ability are known. The positive effects of core stabilisation exercises on balance in hemiplegic patients have been shown in previous studies. In this study, we planned to investigate the effects of bilateral transversus abdominis and bilateral lumbar multifidus muscles on balance 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

December 26, 2023

Status Verified

December 1, 2023

Enrollment Period

7 months

First QC Date

December 13, 2023

Last Update Submit

December 13, 2023

Conditions

Keywords

hemiplegiatransversus abdominismultifidusbalancestroke

Outcome Measures

Primary Outcomes (3)

  • Berg Balance Scale (BBS)

    Patients' balance was evaluated using the Berg Balance Scale.

    Same day with ultrasound-guided muscle measurement

  • Postural Assessment Scale For Stroke Patients (PASS)

    Posture change and posture maintenance scores of the patients were evaluated using PASS.

    Same day with ultrasound-guided muscle measurement

  • Functional Ambulation Category (FAC)

    Ambulation ability of the patients was evaluated using FAC.

    Same day with ultrasound-guided muscle measurement

Secondary Outcomes (3)

  • Brunnstrom Stages

    Same day with ultrasound-guided muscle measurement

  • Transversus Abdominis Muscle Activation

    BBS, PASS, FAC and Brunnstrom stages were measured immediately after recording.

  • Multifidus Muscle Activation

    BBS, PASS, FAC and Brunnstrom stages were measured immediately after recording.

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 MethodProbability Sample
Study Population

36 hemiplegic patients who met the inclusion criteria and did not meet the exclusion criteria

You may qualify if:

  • Patients aged 18-65 years
  • Time after stroke must be at least 1 month
  • Unilateral stroke
  • Must be cognitively compatible in terms of cooperation
  • Standing balance with/without support and/or sitting balance without support
  • BMI\<30

You may not qualify if:

  • Patients with a history of hemiplegia in the opposite half of the body
  • Patients with extruded or sequestered lumbar hernia and/or history of lumbar operation
  • Patients with a history of lumbar vertebral fracture
  • Patients with traumatic brain injury
  • Patients with neuromuscular muscle disease that may lead to muscle atrophy
  • Patients with sensory defects
  • Patients with cerebellar defects
  • Patients with vestibular balance disorders (vertigo, etc.)
  • Patients with Parkinson's disease
  • Patients with balance problems due to visual impairment
  • Patients with pre-stroke balance problems

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

December 26, 2023

Record last verified: 2023-12

Locations