Muscle Oxygenation and Spasticity in Hemiparetic Stroke Patients

The Effect of Spasticity Severity on Peripheral Muscle Oxygenation 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.

Study Overview

• Status: Completed
• Conditions: Stroke; Hemiparesis;Poststroke/CVA; Spasticity as Sequela of Stroke
• Intervention / Treatment: Other: Assessment

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Gazi University, Faculty of Health, Department of Physiotherapy and Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
High-Level Spasticity Group; Hemiparetic stroke patients with spasticity levels greater than or equal 2 on the Modified Ashworth Scale.
Low-Level Spasticity Group; Hemiparetic stroke patients with spasticity levels less than 2 on the Modified Ashworth Scale.
Control Group; Healthy individuals were included in the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Day 1
Spasticity	Plantar flexor muscle spasticity on the affected side will be evaluated with Modified Ashworth Scale	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Day 1
Disability Level	Disability level was determined using the Modified Rankin Scale, which ranges from 0 (no symptoms) to 6 (death).	Day 1
6-Minute Walk Test	Submaximal functional capacity will be evaluated with 6-Minute Walk Test during muscle oxygenation measurement.	Day 1
Stair Climbing Test	Maximal functional capacity will be evaluated with Stair Climbing Test during muscle oxygenation measurement.	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.	Day 1

Collaborators and Investigators

• Sponsor: Ankara Medipol University
• Collaborators: Gazi University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2024
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: April 9, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 17, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: stroke; spasticity; near-infrared spectroscopy; paresis; lower extremity
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Muscle Spasticity; Stroke; Paresis
• Other Study ID Numbers: GaziU-FTR-SS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data will be shared without the participants' private information.
• IPD Sharing Time Frame: starting one year after publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No