An observational study in Stroke, Hemiparesis;Poststroke/CVA and Spasticity as Sequela of Stroke, sponsored by Ankara Medipol University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by Ankara Medipol University · Observational
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.
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.
704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.
This study's enrollment of 30 is below the median of 60 across 162 observational studies indexed under Muscle Spasticity.
Browse Muscle Spasticity studies →Ankara Medipol University is the lead sponsor of 55 studies on the registry; 12 are open to participants now.
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Twenty patients with chronic hemiparetic stroke and 10 healthy controls was conducted at Gazi University, Faculty of Health Sciences, Outpatient Clinics.
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.
Hemiparetic stroke patients with spasticity levels greater than or equal 2 on the Modified Ashworth Scale.
Hemiparetic stroke patients with spasticity levels less than 2 on the Modified Ashworth Scale.
Healthy individuals were included in the control group.
Gastrocnemius Muscle Oxygenation
Gastrocnemius muscle oxygenation will be evaluated with Near-Infrared Spectroscopy at rest, during and after the 6-Minute Walk Test (6MWT) and the Stair Climbing Test (SCT).
Time frame: Day 1
Spasticity
Plantar flexor muscle spasticity on the affected side will be evaluated with Modified Ashworth Scale
Time frame: Day 1
Motor Function
Motor function of the affected limb was assessed using the leg and foot sections of the Chedoke-McMaster Stroke Assessment (1-7 scale).
Time frame: Day 1
Disability Level
Disability level was determined using the Modified Rankin Scale, which ranges from 0 (no symptoms) to 6 (death).
Time frame: Day 1
6-Minute Walk Test
Submaximal functional capacity will be evaluated with 6-Minute Walk Test during muscle oxygenation measurement.
Time frame: Day 1
Stair Climbing Test
Maximal functional capacity will be evaluated with Stair Climbing Test during muscle oxygenation measurement.
Time frame: Day 1
Adipose tissue thickness
The skinfold thickness of gastrocnemius muscle was evaluated with a Skinfold Caliper. Adipose tissue thickness was obtained by dividing the skinfold thickness by two.
Time frame: Day 1
Plan to share: Undecided
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Ankara Medipol University