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NCT Number: NCT06362954

Muscle Oxygenation and Spasticity in Hemiparetic Stroke Patients

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Gastrocnemius Muscle Oxygenation

    Time frame: Day 1

    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).

  2. Spasticity

    Time frame: Day 1

    Plantar flexor muscle spasticity on the affected side will be evaluated with Modified Ashworth Scale

Secondary outcomes

  1. Motor Function

    Time frame: Day 1

    Motor function of the affected limb was assessed using the leg and foot sections of the Chedoke-McMaster Stroke Assessment (1-7 scale).

  2. Disability Level

    Time frame: Day 1

    Disability level was determined using the Modified Rankin Scale, which ranges from 0 (no symptoms) to 6 (death).

  3. 6-Minute Walk Test

    Time frame: Day 1

    Submaximal functional capacity will be evaluated with 6-Minute Walk Test during muscle oxygenation measurement.

  4. Stair Climbing Test

    Time frame: Day 1

    Maximal functional capacity will be evaluated with Stair Climbing Test during muscle oxygenation measurement.

  5. Adipose tissue thickness

    Time frame: Day 1

    The skinfold thickness of gastrocnemius muscle was evaluated with a Skinfold Caliper. Adipose tissue thickness was obtained by dividing the skinfold thickness by two.

Sponsors and collaborators

Lead sponsor

Ankara Medipol University

Other

Collaborators

  • Gazi University

Registry information

Official study title

The Effect of Spasticity Severity on Peripheral Muscle Oxygenation in Hemiparetic Stroke Patients

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 12, 2024
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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