Clinical trial NCT06362954: Muscle Oxygenation and Spasticity in Hemiparetic Stroke Patients
Official title: The Effect of Spasticity Severity on Peripheral Muscle Oxygenation in Hemiparetic Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Hemiparesis;Poststroke/CVA
Spasticity as Sequela of Stroke
Keywords: stroke
paresis
spasticity
near-infrared spectroscopy
lower extremity
Lead sponsor: Ankara Medipol University
Sponsor class: OTHER
Collaborators: name: Gazi University
First posted: 2024-04-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twenty patients with chronic hemiparetic stroke and 10 healthy controls was conducted at Gazi University, Faculty of Health Sciences, Outpatient Clinics.

Brief summary: Conditions such as hemiparesis, sensory and motor impairment, perceptual impairment, cognitive impairment, aphasia, and dysphagia may be observed after stroke. Motor impairment after stroke may occur due to damage to any part of the brain related to motor control. There is much clinical evidence that damage to different parts of the sensorimotor cortex in humans affects other aspects of motor function. Loss of strength, spasticity, limb apraxia, loss of voluntary movements, Babinski sign, and motor neglect are typical motor deficits following a cortical lesion (upper motor neuron lesion). Post-stroke spasticity can be seen in 19% to 92% of stroke survivors. Post-stroke hemiparesis is a significant cause of morbidity and disability, along with abnormal muscle tone. It has also been recognized that post-stroke hemiparesis may occur without spasticity. Spasticity influences muscle hemodynamic and oxidative metabolism, but its impact on the balance between oxygen delivery and utilization is not well understood.

This study study aims to investigate the effect of spasticity severity on peripheral muscle oxygenation in patients with hemiparetic stroke.

Detailed description: Conditions such as hemiparesis, sensory and motor impairment, perceptual impairment, cognitive impairment, aphasia, and dysphagia may be observed after stroke. Motor impairment after stroke may occur due to damage to any part of the brain related to motor control. There is much clinical evidence that damage to different parts of the sensorimotor cortex in humans affects other aspects of motor function. Loss of strength, spasticity, limb apraxia, loss of voluntary movements, Babinski sign, and motor neglect are typical motor deficits following a cortical lesion (upper motor neuron lesion). Post-stroke spasticity can be seen in 19% to 92% of stroke survivors. Post-stroke hemiparesis is a significant cause of morbidity and disability, along with abnormal muscle tone. It has also been recognized that post-stroke hemiparesis may occur without spasticity. Spasticity influences muscle hemodynamic and oxidative metabolism, but its impact on the balance between oxygen delivery and utilization is not well understood.

Motor deficits seen in stroke patients and the conditions caused by them cause various limitations in the daily life of patients and affect their participation in daily life and quality of life. Decreased involvement in daily life negatively affects patients both socially and financially. Evaluating and identifying the disorders, taking preventive and developmental measures, and establishing treatment programs are necessary to increase participation. Therefore, objective and accurate assessment significantly affects the progress of the process.

Medical and surgical treatment and physiotherapy and rehabilitation approaches constitute the basis of treatment in stroke disease. The treatment of patients is carried out using a multidisciplinary approach involving many fields, such as medical and surgical treatment, physiotherapy, and rehabilitation practices. For this reason, it is seen that the financial burden, which cannot be covered by the insurance system from time to time, is relatively high. This burden is gradually increasing in direct proportion to the needs of the patients. For this reason, it is essential to develop practices and strategies for the patient's objective and most accurate evaluation, follow the clinical course, and create the most appropriate treatment program.

Although it is not among the routine evaluation methods, considering the studies conducted, "muscle oxygenation" should be considered in the evaluation phase in line with the possibilities.

Eligibility criteria: Stroke patients were included if they had a confirmed diagnosis (≥6 months post-stroke), were ≥18 years old, had hemiparesis with ankle plantar flexor spasticity, a Chedoke-McMaster Stroke Assessment score of 2-6 (leg/foot), a Modified Rankin Scale score of ≤4, and calf adipose tissue thickness \<20 mm. Healthy controls were age- and gender-matched, ≥18 years old, with calf adipose tissue thickness \<20 mm.

Exclusion criteria included severe uncontrolled hypertension, cardiovascular conditions limiting exercise, unrelated neurological or psychiatric disorders, and sensory impairments affecting the study.

Primary outcomes:
measure: Gastrocnemius Muscle Oxygenation
timeFrame: Day 1
measure: Spasticity
timeFrame: Day 1
Secondary outcomes:
measure: Motor Function
timeFrame: Day 1
measure: Disability Level
timeFrame: Day 1
measure: 6-Minute Walk Test
timeFrame: Day 1
measure: Stair Climbing Test
timeFrame: Day 1
measure: Adipose tissue thickness
timeFrame: Day 1
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University, Faculty of Health, Department of Physiotherapy and Rehabilitation
Study officials:
References: