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Muscle Spasticity clinical trials

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NCT ID: NCT06365476 Recruiting - Stroke Clinical Trials

FlexWave Trial: Efficacy of Extracorporeal Shock Wave Therapy in Post-Stroke Upper Limb Spasticity

Start date: April 15, 2024
Phase: N/A
Study type: Interventional

Extracorporeal shock wave therapy (ESWT) has emerged as an effective therapeutic intervention for addressing post-stroke limb spasticity. This research aims to explore the therapeutic implications of focused ESWT for wrist and finger flexor muscles in patients suffering from post-stroke upper limb spasticity.

NCT ID: NCT06362954 Recruiting - Stroke Clinical Trials

The Relationship Between Muscle Oxygenation and Spasticity in Hemiparetic Stroke Patients

Start date: December 31, 2023
Phase:
Study type: Observational

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.

NCT ID: NCT06357949 Recruiting - Stroke Clinical Trials

The Effectiveness of High-intensity Laser Therapy on Plantar Flexor Muscle Spasticity in Stroke Patients

Start date: April 5, 2024
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effectiveness of high-intensity laser therapy for treating plantar flexor muscle spasticity in subacute and chronic stroke patients, focusing on its impact on spasticity, joint range of motion, pain, muscle thickness, functional ambulation, and quality of life.

NCT ID: NCT06343701 Recruiting - Clinical trials for Cerebral Palsy, Spastic

Investigation of Motor Imaging Skills in Children With Spastic Cerebral Palsy

Start date: July 18, 2023
Phase:
Study type: Observational

The aim of this study was to investigate implicit and explicit motor imagery skills in children with spastic cerebral palsy and typically developing children. The main questions it aims to answer are: - There is a difference between the implicit motor imagery skills of children with bilateral and unilateral CP. - There is a difference between the explicit motor imagery skills of children with bilateral and unilateral CP. - There is a difference between the implicit motor imagery skills of children with cerebral palsy and typically developing children. - There is a difference between the explicit motor imagery skills of children with cerebral palsy and typically developing children.

NCT ID: NCT06340451 Recruiting - Clinical trials for Spasticity, Cerebral or Spinal Condition

Study to Assess the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity

Start date: April 16, 2024
Phase: Phase 3
Study type: Interventional

This multicenter, randomized, double-blind, sham-controlled study is designed to evaluate the efficacy and safety of the iovera° system in subjects with upper extremity spasticity. A total of approximately 132 subjects will be enrolled; 88 subjects will receive treatment with the iovera° system and 44 subjects will receive sham treatment (sham iovera° system treatment).

NCT ID: NCT06330922 Recruiting - Clinical trials for Cerebral Palsy, Spastic

Muscle-tendon Pathology and Metabolic Dysregulation in CP

Start date: March 8, 2024
Phase:
Study type: Observational

The main aim of this project is to gain knowledge about the muscle-tendon pathology of moderately to severely affected young people with cerebral palsy and their risk for cardiometabolic diseases and chronic inflammation. Furthermore, it will be investigated whether there are associations between the existing pathophysiology as well as inactivity and muscle function, cardiometabolic risk factors and inflammation. Moreover, the potential of the target group for adaptation of its muscular, cardiorespiratory, and endocrine system will be investigated. The study parameters will be determined in adolescents and young adults aged 14 to 25 years with moderate to severe spastic cerebral palsy and compared with those of their less severely affected and healthy peers (cross-sectional study). In addition, the more affected individuals will participate in a 12-week training intervention (longitudinal study) performed with special tricycles (i.e., Frame Runners). To measure the study parameters, ultrasound, strength tests, near-infrared spectroscopy, blood analyses, and spiroergometry will be used. The fitness training will be performed two times a week for 12 weeks with the Frame Runners.

NCT ID: NCT06311526 Recruiting - Stroke Clinical Trials

Mechanism of Action of Focal Extracorporeal Shock Waves as a Treatment of Upper Limb Stroke Spasticity: a Pilot Study

SASHA
Start date: May 30, 2023
Phase:
Study type: Observational

Spasticity, common after a stroke, aggravates the patient's motor impairment causing pain and limitation in daily activities such as eating, dressing and walking. There are different spasticity treatments, such as botulinum neurotoxin, in the first place. Among the emerging therapies is focal extracorporeal shock wave therapy, consisting of a sequence of sonic (mechanical) impulses with high peak pressure. Systematic reviews highlighted that shock waves effectively improve lower and upper limb spasticity. Moreover, the shock waves therapeutic effect can last up to 12 weeks from the last treatment session. When used to treat stroke spasticity, the shock waves' mechanism of action is poorly detailed. On the one side, shock waves could change the physical properties of the muscular tissue (e.g. viscosity, rigidity). On the other, the shock waves produce a robust mechanical stimulation that massively activates muscle and skin mechanoreceptors (e.g. muscle spindles). This activation would modulate, in turn, the spinal (and supra-spinal) circuits involved in spasticity. To our knowledge, no study investigated the shock waves mechanism of action in stroke upper limb spasticity. Research question: do shock waves exert their therapeutic effect on spasticity by changing the muscle's physical properties or by indirectly modulating the excitability of spinal circuits? Specific aims: To investigate the mechanism of action of shock wave therapy as a treatment of upper limb spasticity after a stroke. Two major hypotheses will be contrasted: shock waves reduce hypertonia 1) by changing the muscle's physical features or 2) by changing the motoneurons excitability and the excitability of the stretch reflex spinal circuits. Shock wave therapy is expected to improve spasticity, thus improving the following clinical tests: the Modified Ashworth Scale (an ordinal score of spasticity) and the Functional Assessment for Upper Limb (FAST-UL, an ordinal score of upper limb dexterity). This clinical improvement is expected to be associated with changes in spastic muscle echotexture assessed with ultrasounds, such as an improvement in the Heckmatt scale (an ordinal score of muscle echotexture in spasticity). Clinical improvement is also expected to be associated with an improvement in the following neurophysiological parameters: a reduction of the H/Mmax ratio (an index of hyperexcitability of the monosynaptic stretch reflex circuit), a decrease in amplitude of the F waves (a neurophysiological signal reflecting the excitability of single/restricted motoneurones) and an increase of the homosynaptic depression (also known as post-activation depression, reflecting the excitability of the transmission between the Ia fibres and motoneurones). Understanding the shock wave mechanism of action will lead to a better clinical application of this spasticity treatment. If the shock waves exert their therapeutic effect by changing the muscle's physical properties, they could be more appropriate for patients with muscle fibrosis on ultrasounds. On the contrary, if the shock waves work on spasticity by indirectly acting on the nervous system's excitability, then a neurophysiology study could be used to preliminary identify the muscle groups with the most significant neurophysiological alterations, which could be the muscles benefitting the most from this treatment.

NCT ID: NCT06309810 Recruiting - Spasticity/Paresis Clinical Trials

Stereotactic Radiosurgery (SRS) in Malignant Spasticity and Hypertonia

Start date: March 6, 2023
Phase: N/A
Study type: Interventional

This is a pilot, experimental, monocentric study. The main objective of the study is to evaluate whether stereotactic radiotherapy is able to reduce symptomatic spasticity from a clinical point of view, and therefore induce an improvement in posture and quality of life in patients with malignant spasticity. The study foresees the enrollment of about 10 patients, in a period of 24 months. The radiotherapy treatment will be delivered in a single session with an image-guided stereotaxic technique, and a prescription dose between 45 and 60 Gy; subsequently the patients will be followed up for one year.

NCT ID: NCT06270550 Recruiting - Spastic Diplegia Clinical Trials

Role of Dynamic Movement Intervention in Children With Spastic Diplegia

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

The study aims to investigate the effect of dynamic movement intervention approach on static and dynamic balance, quality of step length and cadence of walking pattern of children with spastic diplegic cerebral palsy.

NCT ID: NCT06260982 Recruiting - Spastic Paraplegia Clinical Trials

Cognitive Disorders in Hereditary Spastic Paraplegia Type 4

SPG-TEP
Start date: January 1, 2022
Phase:
Study type: Observational [Patient Registry]

Hereditary spastic paraplegia type 4 is the most frequent mutation of hereditary spastic paraplegias. It is commonly described as pure, with progressive weakness of the lower limbs, pyramidal syndrome and vesico-sphincter disorders. However, cognitive disorders have been reported for over 20 years, but remain poorly characterized.