ClinicalTrials.Veeva

Menu

The Relationship Between Muscle Oxygenation and Spasticity in Hemiparetic Stroke Patients

A

Ankara Medipol University

Status

Enrolling

Conditions

Hemiparesis;Poststroke/CVA
Stroke
Spasticity as Sequela of Stroke

Treatments

Other: Assessment

Study type

Observational

Funder types

Other

Identifiers

NCT06362954
AnkaraMedipolU-FTR-SS-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

18 participants in 3 patient groups

High-Level Spasticity
Description:
Hemiparetic stroke patients with spasticity levels 3 and 4 on The Modified Ashworth Scale
Treatment:
Other: Assessment
Low-Level Spasticity
Description:
Hemiparetic stroke patients with spasticity levels between 1 and 2 on The Modified Ashworth Scale
Treatment:
Other: Assessment
No Spasticity
Description:
Hemiparetic stroke patients with spasticity level 0 on The Modified Ashworth Scale
Treatment:
Other: Assessment

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems