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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06362954
Other study ID # AnkaraMedipolU-FTR-SS-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 31, 2023
Est. completion date June 1, 2024

Study information

Verified date April 2024
Source Ankara Medipol University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 seen after stroke causes loss of movement control, painful spasms, abnormal posture, increased muscle tone, and a general decrease in muscle function, and may affect limb blood flow. Studies in the literature show that spasticity can affect limb blood flow. This study aims to investigate the relationship between muscle oxygenation and spasticity in post-stroke hemiparetic patients based on the idea that oxygenation may be insufficient as a result of restriction of blood flow on the affected side due to spasticity in stroke patients.


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 seen after stroke causes loss of movement control, painful spasms, abnormal posture, increased muscle tone, and a general decrease in muscle function, and may affect limb blood flow. Studies in the literature show that spasticity can affect limb blood flow. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 18
Est. completion date June 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Volunteering to participate in the study - To be diagnosed with stroke by a specialist physician - Age = 18 years - At least six months after the stroke - Having a stage 2-6 motor recovery of the affected side's leg and foot on the Chedoke-McMaster Stroke Assessment - Bilateral gastrocnemius muscle adipose tissue thickness <20mm Exclusion Criteria: - Severe uncontrolled hypertension or orthostatic blood pressure drop >20 mmHg - Cardiovascular diseases that limit exercise tolerance - Uncontrolled blood sugar - Previous neurological or psychiatric disease not related to stroke - Having hearing, vision, and perception problems that may affect research results

Study Design


Intervention

Other:
Assessment
Chedoke-McMaster Stroke Assessment (CMSA), Modified Ashworth Scale (MAS), Near-Infrared Spectroscopy (NIRS), 6-Minute Walk Test (6MWT), Stair Climbing Test (SCT), Adipose Tissue Thickness

Locations

Country Name City State
Turkey Gazi University, Faculty of Health, Department of Physiotherapy and Rehabilitation Ankara Çankaya

Sponsors (2)

Lead Sponsor Collaborator
Ankara Medipol University Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plantar Flexors Muscle Oxygenation Bilateral plantar flexor muscles oxygenations will be evaluated with Near-Infrared Spectroscopy at rest, during the 6-Minute Walk Test (6MWT) and Stair Climbing Test (SCT). First day
Secondary Spasticity Plantar flexor muscle spasticity on the affected side will be evaluated with Modified Ashworth Scale First day
Secondary Motor Function Motor functions on the affected side will be evaluated with Chedoke-McMaster Stroke Assessment. First day
Secondary 6-Minute Walk Test Submaximal functional capacity will be evaluated with 6-Minute Walk Test during muscle oxygenation measurement. First day
Secondary Stair Climbing Test Maximal functional capacity will be evaluated with Stair Climbing Test during muscle oxygenation measurement. First day
Secondary Adipose tissue thickness The skinfold thickness of bilateral plantar flexor muscles will be evaluated with a Skinfold Caliper. Adipose tissue thickness will be obtained by dividing the skinfold thickness by two. First day
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