Osteoporosis After Stroke

N/ANot Yet RecruitingNCT07059468

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital44 enrolled

Overview

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.

One of the common complications after stroke is secondary osteoporosis that develops due to stroke. The most important event that draws attention to bone health in stroke patients is fractures, the most serious of which in terms of morbidity and mortality are hip fractures. The risk of hip fracture in stroke patients is 2-4 times higher than the normal population due to the decrease in bone mineral density on the plegic side and the increased risk of falling. There is a loss of bone mineral density after stroke. This loss is faster and larger in the early stages of stroke and is greater on the plegic side. The factors affecting this loss of bone mineral density after stroke have not been well defined. The relationship between stroke-related bone mineral density loss and motor function, functional mobility, balance, and muscle mass is not clear. It is important to reveal the changes in bone structure after stroke and the factors affecting this change. 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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Stroke Osteoporosis

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)DIAGNOSTIC_TEST

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

Sex: ALLMin age: 40 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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.)

Locations (1)

Sbü Ankara Gaziler Fizik Tedavi Ve Rehabilitasyon Eğitim Ve Araştirma Hastanesi

Ankara, Turkey (Türkiye)

Outcomes

Primary Outcomes

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

Time frame: baseline

Secondary Outcomes

Manual muscle strength measurement/ Muscle strength

Manual muscle strength measurement/ Muscle strength will be evaluated by the Medical Research Council muscle strength scale. This scale is a 6-point scale. (0 = no movement; 1 = tremor of movement; 2 = movement with gravity eliminated; 3 = movement against gravity; 4 = movement against resistance; 5 = full strength

Time frame: baseline

Fugl-Meyer Lower Extremity Motor Subscale

This scale evaluates motor function, sensory function, balance, range of motion, and joint pain, and the maximum score is 226. The maximum possible scores on the motor scale are 100 points for the upper (66) and lower (34) extremities, 24 for the sensory scale, 14 for balance, 44 for range of motion, and 44 for joint pain. The motor scale evaluates the mobility of the shoulder, elbow, forearm, wrist, hand, hip, knee, and ankle. Accordingly, 0 indicates that the movement cannot be performed, 1 indicates that it can be performed partially, and 2 indicates that the movement can be performed fully. The motor scale also includes reflex and coordination-speed evaluations (Gladstone et al., 2002). The motor-coordination subscale has a maximum score of 66 points for the upper extremity and a maximum score of 34 points for the lower extremity. Higher scores indicate better motor recovery. In this study, lower extremity motor subscale will be used

Time frame: baseline

Functional Ambulation Classification

The Functional Ambulation Classification is a functional walking test that evaluates ambulation ability. It includes six different categories and assesses ambulation status by determining how much support the patient needs while walking, regardless of whether they use assistive devices.

Central Contacts

Pelin Mutlu Arı, MD

CONTACT

+90 312 291 10 00 plnmutlu93@gmail.com

Tugba Atan, Assoc. Prof.

CONTACT

+90 312 291 10 00 tubaatan@gmail.com

Data from ClinicalTrials.gov

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