Brief Summary

The aim of this study was to investigate the clinical features affecting bone mineral density in plegic and non-plegic extremities in hemiplegic patients with stroke in the subacute and chronic phases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2025

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

First Submitted

Initial submission to the registry

July 1, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

July 11, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2026

Completed
Last Updated

March 30, 2026

Status Verified

July 1, 2025

Enrollment Period

9 months

First QC Date

July 1, 2025

Last Update Submit

March 25, 2026

Conditions

Keywords

Stroke Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Dual X-ray absorptiometry (DXA)

    Bone mineral density/ Bone mineral density (BMD) will be measured on the lumbar spine (L1-L4) and femoral neck by dual X-ray absorptiometry (DXA) method./ Baseline

    baseline

Secondary Outcomes (7)

  • Manual muscle strength measurement/ Muscle strength

    baseline

  • Fugl-Meyer Lower Extremity Motor Subscale

    baseline

  • Functional Ambulation Classification

    baseline

  • Spasticity assessment/ Ashworth graded spasticity from 0 to 4

    baseline

  • Berg Balance Scale

    baseline

  • +2 more secondary outcomes

Interventions

Bone mineral density/ Bone mineral density (BMD) will be measured on the lumbar spine (L1-L4) and femoral neck by dual X-ray absorptiometry (DXA) method

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

44 Patients aged 40-65 years with a unilateral stroke confirmed by magnetic resonance imaging (MRI) or computed tomography (CT)

You may qualify if:

  • Patients aged 40-65 years with a unilateral stroke confirmed by magnetic resonance imaging (MRI) or computed tomography (CT)
  • Patients with a cognitive status sufficient to understand the study instructions (Mini-Mental State Assessment score ≥ 23)
  • Patients with stable medical and psychological status
  • Patients willing to participate in the study

You may not qualify if:

  • Presence of hip pathologies that may lead to incorrect measurements in bone mineral density (advanced osteophytic coxarthrosis, heterotrophic ossification, internal fixator, etc.)
  • Previous hip, lumbar vertebra fractures (osteoporotic compression fractures)
  • History of multiple strokes
  • History of concomitant neurological diseases other than stroke (Parkinson, multiple sclerosis, myopathy, etc.)
  • History of diseases that may cause secondary osteoporosis (hypogonadism, primary hyperparathyroidism, thyrotoxicosis, malabsorption, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sbü Ankara Gaziler Fizik Tedavi Ve Rehabilitasyon Eğitim Ve Araştirma Hastanesi

Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

StrokeOsteoporosis

Interventions

Bone Density

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Engin Koyuncu, Prof.

    SBÜ ANKARA GAZİLER FİZİK TEDAVİ VE REHABİLİTASYON EĞİTİM VE ARAŞTIRMA HASTANESİ

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof

Study Record Dates

First Submitted

July 1, 2025

First Posted

July 10, 2025

Study Start

July 11, 2025

Primary Completion

March 25, 2026

Study Completion

March 25, 2026

Last Updated

March 30, 2026

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations