RU2841090C1 - Method for diaphragm function recovery in patients with hemiparesis as result of stroke - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to rehabilitation, physiotherapy, neurology, and aims at diaphragm function recovery in the integrated treatment of the patients with diaphragm dysfunction caused by stroke. Magnetic stimulation represents a local exposure to a magnetic field generated by a magnetic inductor. Exposure is generated by a figure-of-eight magnetic inductor. Magnetic stimulation covers an area of a shoulder joint on the affected side above a deltoid muscle. That is followed by the local exposure to an alternating magnetic field of MagPro R30 magnetic stimulator. At that, the maximum power is 2700 VA, the peak magnetic induction is 2.0 T, with frequency of 20 Hz, 25 pulses in a pack, 100 packs, total number of pulses 2500 with intensity 25 to 75% of peak magnetic induction, number of procedures 10, five days a week.

EFFECT: method provides more effective medical rehabilitation in the diaphragm malfunction in the patients with hemiparesis caused by stroke.

1 cl, 2 dwg, 2 tbl, 2 ex

Description

The invention relates to medicine, namely to rehabilitation, physiotherapy, neurology, and is intended to restore diaphragm function in the complex treatment of patients with diaphragm dysfunction as a result of a stroke.

According to the World Stroke Organization, from 1990 to 2019, the absolute number of registered cases of cerebral stroke in the world increased by 70%, deaths from stroke - by 43.0%. Stroke remains the second leading cause of death and the third leading cause of death and disability combined, which is expressed in the sum of potential years of life lost due to premature death or disability (Disability-Adjusted Life-Years (DALYs)) in the world (World Stroke Organization (WSO), 2022). Such statistics are associated with the general trend of increasing life expectancy, as well as the persistent insufficient prevention of cardiovascular diseases in a number of countries. One of the most common complications of stroke is hemiparesis on the contralateral side of the body, which occurs in 70-90% of cases (Levin O.S. et al., Post-stroke motor and cognitive impairment: clinical features and modern approaches to rehabilitation, Korsakov Journal of Neurology and Psychiatry. 2020; 120 (11): pp. 99-107). According to the World Health Organization (WHO), 70% of patients in the European Union experienced hemiparesis within the first month after a stroke, and 40% of patients continued to have hemiparesis after 6 months from the onset of the disease. The main dysfunctions of the upper limb (FUL) are decreased muscle strength and the occurrence of muscle contractures as a result of immobilization, impaired muscle tone, joint stability, and movement incoordination, which affects such important FUL as support, balancing, and grasping. Violation of the FVC significantly affects all aspects of the patient's health, significantly changing the overall level of his activity, independence, self-esteem, and participation in everyday life.

Complications such as joint subluxations and muscle contractures lead to manifestations of nociceptive musculoskeletal pain. Shoulder subluxation is a common complication of post-stroke hemiplegia. The incidence of shoulder subluxation in patients after stroke ranges from 7 to 81%, with 73% occurring in the acute stage. A 10-month study (Jung KM et al, The Effects of Active Shoulder Exercise with a Sling Suspension System on Shoulder Subluxation, Proprioception, and Upper Extremity Function in Patients with Acute Stroke, Med Sci Monit. 2019;25, p.4849-4855) found that shoulder subluxation worsened over time in 67% of patients. This condition can cause shoulder pain that worsens over time. In this regard, active treatment and rehabilitation of shoulder subluxation to restore the FVC in patients with stroke should begin in the acute period of the disease.

In half of the cases of ischemic stroke, there is also a dysfunction of the diaphragm in the form of paresis, leading to flattening and displacement of the diaphragm dome, a decrease in contractile function and diaphragm excursion (Catala-Ripoll JV et al, Incidence and predictive factors of diaphragmatic dysfunction in acute stroke, BMC Neurol. 2020 Mar 5;20(1), p.79; Liu X et al, Assessment of Diaphragm in Hemiplegic Patients after Stroke with Ultrasound and Its Correlation of Extremity Motor and Balance Function, Brain Sci. 2022 Jul 4; 12(7), p.882). Most often, this disorder occurs on the side of hemiparesis, but in some cases the opposite side or both halves of the diaphragm are affected.

The diaphragm is not only the main respiratory muscle of a person, providing the depth and intensity of inhalation and exhalation, it also plays an important role in maintaining intra-abdominal pressure, static and dynamic balance, participates in motor synergies with the muscles of the shoulder girdle and upper limb, as well as swallowing and speech functions. In patients with cerebral stroke, the function of the diaphragm can be impaired on the side of hemiparesis in more than half of the cases, negatively affecting the entire recovery process.

Dysfunction of the diaphragm in the form of decreased contractility and excursion during breathing on the side of hemiparesis were observed in studies in the acute phase of stroke in 51.7% (Catala-Ripoll JV et al, Incidence and predictive factors of diaphragmatic dysfunction in acute stroke, BMC Neurol., 2020 Mar, 5,20(1), p.79), and in the recovery period in 46.7% of patients (Liu X et al, Assessment of Diaphragm in Hemiplegic Patients after Stroke with Ultrasound and Its Correlation of Extremity Motor and Balance Function, Brain Sci, 2022 Jul, 4, 12(7), p.882). To determine diaphragm dysfunction in clinical settings, ultrasound examination is successfully used, which allows determining the thickness, the degree of thickening of the diaphragm on inhalation, as well as the excursion of the diaphragm during the respiratory cycle (Table 1). In order to assess the function of the diaphragm in clinical conditions, functional scales and tests for assessing balance and upper limb function are also used.

During the recovery period of a stroke (1-12 months from the moment of the stroke), methods of therapeutic exercise, physiotherapy, speech therapy, and psychological rehabilitation are used to correct movement disorders.

A number of studies have proven the correlation between ELF impairment and diaphragm dysfunction. Moreover, the diaphragm plays an important role in maintaining intra-abdominal pressure, static and dynamic balance, and participates in motor synergies with the muscles of the shoulder girdle and upper limb, according to Thomas Myers's anatomical train theory. Diaphragm dysfunction is caused by the involvement of the cortico-diaphragmatic tracts, and the severity of diaphragmatic breathing disorders correlates with the severity of motor (pyramidal) disorders (Liu X et al, Assessment of Diaphragm in Hemiplegic Patients after Stroke with Ultrasound and Its Correlation of Extremity Motor and Balance Function, Brain Sci, 2022 Jul, 4, 12(7), p.882). On the side of hemiparesis, flattening and displacement of the diaphragm dome occurs, the diaphragm excursion and diaphragmatic pressure during inhalation and exhalation decrease, which leads to disruption of the physiological process of breathing. There are cases of correlation of diaphragm dysfunction with impaired swallowing function (Yun RY et al, Correlation of Swallowing Function with Bilateral Diaphragmatic Movement in Hemiplegic Stroke Patients, Ann Rehabil Med. 2019 Apr;43(2), p. 156-162), rotator cuff pathology (Fernandez-Lopez I et al, Effects of diaphragm muscle treatment in shoulder pain and mobility in subjects with rotator cuff injuries: A dataset derived from a pilot clinical trial, Data Brief. 2021 Feb 12; 35, p. 106867), and impaired postural control.

A direct relationship between the diaphragm excursion during deep breathing on the side of hemiparesis and the Fugl-Mayer and Berg scales (p<0.05) was also confirmed. Both indicators - FM and Berg show a moderate positive correlation with each other, as well as with the FIM independence scale (p<0.05) (Melnikova E.A. et al., The Impact of Patient Motivation on the Restoration of Motor Function in the Recovery Period of Stroke. Preliminary Results of a Clinical Study, Physical and Rehabilitation Medicine, Medical Rehabilitation. - 2024. - Vol. 6. - No. 2, pp. 122-130).

A strong association was found between severe upper limb paresis (1-3 points on the MRC scale) and the frequency of diaphragm dysfunction using Fisher's exact test (two-sided) (FET=0.00006; p<0.05). No cases of diaphragm dysfunction were found with less severe upper limb paresis.

Diaphragm dysfunction is more associated with the severity of motor impairment - the degree of upper limb paresis, limitation of passive range of motion, and shoulder pain. In 100% of cases, diaphragm dysfunction occurs with an upper limb paresis grade of 1 to 3 on the MRC scale (O'Dell MW et al, Stroke Rehabilitation and Motor Recovery, Continuum (Minneap Minn). 2023 Apr 1;29(2), p.605-627). Therefore, the degree of upper limb paresis can be considered a predictor of diaphragm dysfunction. The presence of severe upper limb paresis even in the late recovery period of stroke is a reason to evaluate diaphragm function.

The closest in technical essence to the proposed method is the method of treating movement disorders using peripheral or neuromuscular electrical stimulation (NMES) (Sousa ASP et al, Usability of Functional Electrical Stimulation in Upper Limb Rehabilitation in Post-Stroke Patients: A Narrative Review, Sensors (Basel), 2022 Feb, 12, 22(4), p.1409). NMES consists of a series of intermittent electrical stimuli acting on a muscle or nerve trunk to induce tetanic muscle contractions. In patients who have suffered a stroke, NMES is used to facilitate voluntary movements when performing functional tasks, in which case it is referred to as Functional Electrical Stimulation (FES). In fact, FES consists of applying cyclic electrical stimulation of moderate intensity to selected muscles to create functional movements that imitate voluntary contractions and restore lost functions, for example, during cyclic loads (exercise bike, motomed, walking).

Electrical stimulation can be delivered using electrodes of varying degrees of invasiveness; they can be fully or partially implanted (called implanted and transcutaneous electrodes, respectively) or placed on the body surface (cutaneous or surface electrodes). Each type of electrode has its own advantages and disadvantages in terms of flexibility, stimulation specificity, ease of use, and cost. Table 1 provides a summary of the types of electrodes commonly used for stimulation (Marquez-Chin C et al, Functional electrical stimulation therapy for restoration of motor function after spinal cord injury and stroke: a review, Biomed Eng Online, 2020 May, 24,19(1), p. 34).

Typical pulse frequencies range from 20 to 50 Hz. Higher stimulus frequencies produce stronger tetanic contractions, which can lead to faster muscle fatigue.

The impulses used for stimulation can be divided into monophasic and biphasic. In turn, biphasic impulses can be divided into symmetrical and asymmetrical. It is believed that monophasic impulses can have a negative effect, since they transmit energy to the body that is never removed, creating, among other things, the possibility of damage to the stimulated tissues. On the other hand, biphasic impulses alternate the anode and cathode electrodes with each stimulation impulse, which is safer for the person receiving the stimulation. Symmetrical biphasic impulses, as the name suggests, consist of two phases that are identical in duration and amplitude, the only difference between them is polarity. In contrast, asymmetrical biphasic impulses also have two phases of opposite polarity, but they are not identical in either amplitude or duration.

Determining the optimal placement of the electrodes is often done empirically: the electrodes are first placed over the nerve(s) innervating the muscle to be stimulated, and stimulation is performed. If the resulting movement is desired, the process is complete. Otherwise, the electrodes are moved (usually with minor adjustments, no more than a few centimeters) and the process is repeated until the desired movement is achieved.

The intensity of the impact is selected individually, it is determined by the duration and amplitude of the pulse, taking into account the following indicators (common to all types of electromagnetic stimulation):

• Sensory threshold is the lowest intensity at which stimulation can be perceived by the person receiving the stimulation, even if no movement occurs.

• Motor threshold is the minimum intensity that results in a visible muscle contraction, even if the contraction does not result in movement.

• Maximum Tolerable Intensity is the maximum level a person can tolerate without experiencing discomfort.

• The operative stimulation intensity is the intensity used for stimulation during the procedure.

The electrical stimulation method has a number of contraindications and limitations according to known data (Marquez-Chin C et al, Functional electrical stimulation therapy for restoration of motor function after spinal cord injury and stroke: a review, Biomed Eng Online, 2020 May, 24,19(1), p. 34):

• Poor skin condition: pressure sores or irritation prevent the use of self-adhesive electrodes.

• Poorly controlled epilepsy: FES can be used during remission or under drug control.

• Autonomic dysreflexia.

• Pregnancy. The effect of FES on the unborn child during pregnancy is unknown.

• Pacemakers: Electrical stimulation may interfere with the electrical signals of pacemakers, causing them to malfunction.

• Cancerous tumor in the area of electrical stimulation.

• Exposed Metal: Patients with exposed orthopedic metal should not undergo electrical stimulation of the affected area.

• Non-healing fracture: Muscle contractions caused by FES around a non-healing fracture may result in a displaced fracture.

• Suspected, diagnosed or uncontrolled cardiovascular diseases.

• Botulinum toxin. Patients undergoing botulinum toxin therapy may not respond to stimulation.

There is also a known method for restoring peripheral muscle function in cases of muscle spasticity and impaired motor functions in patients undergoing rehabilitation after a stroke, which includes magnetic stimulation in the form of local exposure to a magnetic field from a magnetic inductor, which we adopted as a prototype (Catalog of the Reamed company, NEURO-MSX transcranial and peripheral magnetic stimulation device, section "Rhythmic peripheral magnetic stimulation (rPMS)", found on the Internet https://reamed.su/catalog/product/apparat-transkranialnoy-magnitnoy-stimulyatsii-neuro-msx/ 11/23/2023). However, this source does not specifically describe the modes and protocols for restoring diaphragm function in patients with hemiparesis due to a stroke.

Thus, there is a need for a method for restoring diaphragm function in patients with hemiparesis due to stroke that is free from the above-mentioned disadvantages.

The technical result of the proposed method is to increase the efficiency of rehabilitation treatment for this pathology; the method allows to obtain the following positive effects: firstly, under the influence of an alternating magnetic field with the specified characteristics, stimulation of efferent neurons occurs, leading to the restoration of neuromuscular conductivity at the diaphragm level, increased contractility of muscle fibers, improved blood supply and nutrition; secondly, stimulation of afferent neurons leads to the restoration of corticospinal conductivity, sensitivity, normalization of reflex activity and control of voluntary movements. The result of this effect will be the restoration of the diaphragm function, as well as balance, equilibrium, motor function of the upper limb, swallowing and speech.

In order to achieve the specified technical result in the method for restoring the function of the diaphragm in patients with hemiparesis as a result of a stroke, including magnetic stimulation in the form of local exposure to a magnetic field from a magnetic inductor, it is proposed to carry out the exposure with a figure-eight magnetic inductor, while magnetic stimulation is performed on the shoulder joint area on the affected side above the deltoid muscle, in the form of local exposure to an alternating magnetic field of a MagPro R30 magnetic stimulator with a maximum power of 2700 VA, a peak magnetic induction of 2.0 T, with a gap between the inductor and the skin surface of 0.5 cm, a frequency of 20 Hz, 25 pulses per pack, 100 packs, a total number of pulses of 2500, with an intensity of 25 to 75% of the peak magnetic induction with a number of procedures of 10, five days a week.

Fig. 1 illustrates the area of action of the figure-eight inductor on the shoulder joint area on the affected side above the deltoid muscle.

Fig. 2 illustrates the external localization of the imposition of a figure-eight inductor.

The method is carried out as follows.

During the peripheral magnetic stimulation procedure, the patient is positioned on a couch lying on his side (on the side contralateral to the hemiparesis) or sitting with his arms down. The effect is carried out by a figure-eight magnetic inductor, while magnetic stimulation is performed on the shoulder joint area on the affected side above the deltoid muscle (Fig. 1, Fig. 2), in the form of local exposure to an alternating magnetic field (conducted from a MagPro R30 magnetic stimulator with a maximum power of 2700 VA (Volt-Ampere), an eight-shaped inductor with a diameter of 8 mm x 2, a peak magnetic induction of 2.0 T, a peak electrical induction of 530 V/m.

The intensity of the operative stimulation is selected individually, in the range from 25 to 75% of the peak magnetic induction, based on the patient's comfort. After the procedure, the patient is in the initial position sitting or lying on his back for 10 minutes.

These parameters are selected optimally taking into account an adequate muscular response, at the same time comfortably and painlessly tolerated by the patient; completing a full course of 10 procedures, five days a week, leads to the restoration of neuromuscular conductivity at the level of the diaphragm, increased contractility of muscle fibers, improved blood supply and nutrition.

The physiological basis of the method of rhythmic peripheral magnetic stimulation (rPMS) is associated with the occurrence of induced electric current as a result of magnetic induction with subsequent activation of the conductive structures of the central and peripheral nervous system.

Contraindications to the procedure are heart rhythm disturbances.

Magnetic stimulation has a number of advantages over electrical stimulation, expressed in the non-invasive nature of the effect, greater efficiency - the possibility of using stimuli of lower intensity, deeper impact, the absence of stimulation of skin receptors and associated painful sensations (Blokhina V.N. et al., Application of rhythmic peripheral magnetic stimulation (rPMS), Bulletin of the National Medical and Surgical Center named after N.I. Pirogov. 2016. No. 3, pp. 111-117).

The proposed treatment method was used in 12 patients. A good clinical effect was achieved in 10 patients (83.3%) - clinically significant progress in motor, strength and balance indicators. The study included patients aged 36 to 82 years, who were at the second stage of rehabilitation due to stroke in the recovery period, the period from the moment of stroke from 1 to 12 months. The severity of the patients' condition was from 3 to 4 points on the Rehabilitation Routing Scale. The average level of limb paresis according to the WHO Expert Scale upon admission was - 3.0 ± 1.6 points, the average level of spasticity according to the modified Ashworth scale was 2.4 ± 0.8 points. Pain syndrome in the shoulder joint on the side of hemiparesis was observed in 8 patients (66.7%). The average pain level according to VAS was 3 ± 2.0 points. Impaired contractile function of the diaphragm was determined by functional ultrasound. The following parameters were used: bilateral thickening index, normal breathing excursion, and deep inhalation excursion. The Berg scale and Morse fall risk scale were used to assess balance. The Fugl-Mayer test was used to assess upper limb function.

Upon completion of the treatment course, there was a statistically significant increase in the diaphragm thickening index by 13+6.6 percentage points (p<0.05); an increase in the diaphragm excursion during deep inspiration by 4.9+3.7 mm (p<0.05); an improvement in balance - an increase in the Berg scale score by 8.6+3.4 points (p<0.05) and a decrease in the risk of falling on the Morse scale by 10+5.0 points (p<0.05), an increase in strength in the upper limbs to 3.9+0.7 points, accompanied by an expansion of motor activity - an increase on the Fugl-Mayer scale by 8+4.0 points (p<0.05); regression of spasticity to -1.3+1.7 points.

Thus, according to the main indicators, 12 patients in the main group showed a statistically significant improvement compared to the control group of 16 patients.

The high efficiency of the proposed method is also confirmed by the clinical examples below.

Example 1. Example 1. Patient C, 56 years old.

Admitted with the diagnosis: "Ischemic stroke in the left middle cerebral artery basin. Atherothrombotic subtype according to TOAST. Right-sided hemiparesis."

Complaints on admission: Pain in the shoulder joint when attempting to abduct the arm (VAS score = 4 points)

From the anamnesis: he was admitted to the 2nd stage of rehabilitation 82 days after the stroke.

Status upon admission: Paresis of the right upper limb: 2-2-2 points according to the WHO expert scale. Muscle tone of the right upper limb is 3-3-2 points according to Ashworth. Balance assessment according to the Berg scale: 42 points. Risk of falling according to the Morse scale is 55 points. Diaphragm thickening index according to ultrasound data on the right during inhalation is 19%; diaphragm excursion during normal breathing is 12 mm, during deep inhalation - 34 mm. Assessment of upper limb function according to the Fugl-Mayer scale is 46.

The patient underwent a course of peripheral magnetic stimulation with a frequency of 20 Hz, 25 pulses per pack, 100 packs, the total number of pulses per procedure is 2500, with an intensity of 75% of the peak magnetic induction, the number of procedures is 10, in a complex of rehabilitation measures (physical therapy, mechanotherapy with biofeedback, psychological correction).

The treatment resulted in improvement of the upper limb motor function by 10 points (56 points on the Fugl-Mayer scale); improvement of upper limb muscle strength by 1 point (3-3-3); decrease in increased muscle tone of the upper limb by 0.5-1.5 points (1.5-1.5-1.5); improvement of balance function by 11 points on the Berg scale (53 points), decrease in the risk of falling on the Morse scale by 10 points (45 points). The diaphragm thickening index according to ultrasound data on the right during inhalation increased by 10 percentage points and amounted to 29%. Diaphragm excursion during normal breathing increased by 2 mm (14 mm), during deep breathing by 6 mm (40 mm). Pain in the shoulder joint decreased by 2 points (VAS = 2 points).

Example 2. Patient A., 69 years old.

Admitted with the diagnosis: "Ischemic stroke in the left middle cerebral artery basin, TOAST subtype not determined. Right-sided moderate hemiparesis."

Complaints upon admission: impaired coordination, unsteady gait, pain in the area of the right shoulder joint (VAS score = 5 points) when moving the joint, impaired movement in the right arm.

From the anamnesis: she was admitted to the 2nd stage of rehabilitation 263 days after the stroke.

Status upon admission: Paresis of the right upper limb: 2-2.5-2 points according to the WHO expert scale. Muscle tone of the right upper limb: 2-2-3 points according to Ashworth. Balance assessment according to the Berg scale: 36 points. Risk of falling according to the Morse scale is 55 points. Diaphragm thickening index according to ultrasound data on the right during inhalation is 6%; diaphragm excursion during normal breathing is 7 mm, during deep breathing - 17 mm. Assessment of upper limb function according to the Fugl-Mayer scale is 40.

The patient underwent a course of peripheral magnetic stimulation with a frequency of 20 Hz, 25 pulses per pack, 100 packs, the total number of pulses per procedure is 2500, with an intensity of 25% of the peak magnetic induction, the number of procedures is 10, in a complex of rehabilitation measures (physical therapy, mechanotherapy with biofeedback, psychological correction).

The treatment resulted in progress of the upper limb motor function by 12 points (52 points on the Fugl-Mayer scale); upper limb muscle strength by 0.5-1 point (3-3-3); decrease in increased tone of the upper limb by 1-1.5 points (1-1-1.5); improvement of balance function by 14 points on the Berg scale (50 points), decrease in the risk of falling on the Morse scale by 10 points (45 points). The diaphragm thickening index according to ultrasound data on the right during inhalation increased by 15 percentage points and amounted to 21%. Diaphragm excursion during normal breathing increased by 7 mm (14 mm), during deep breathing by 9 mm - (26 mm). Pain in the right shoulder decreased by 3 points (VAS = 2 points). The patient began to use her right hand for self-care.

The method is safe. No immediate or remote side or undesirable effects were detected. Thus, the proposed invention allows to increase the effectiveness of treatment of patients in the recovery period of stroke, i.e. it provides more pronounced dynamics of progress of motor and balance functions.

Claims (1)

A method for restoring diaphragm function in patients with hemiparesis as a result of a stroke, including magnetic stimulation in the form of local exposure to a magnetic field from a magnetic inductor, characterized in that the exposure is carried out with a figure-eight magnetic inductor, while magnetic stimulation is performed on the shoulder joint area on the affected side above the deltoid muscle in the form of local exposure to an alternating magnetic field of a MagPro R30 magnetic stimulator with a maximum power of 2700 VA, a peak magnetic induction of 2.0 T, with a gap between the inductor and the skin surface of 0.5 cm, a frequency of 20 Hz, 25 pulses per pack, 100 packs, a total number of pulses of 2500 with an intensity of 25 to 75% of the peak magnetic induction, a number of procedures of 10, five days a week.