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Paresis clinical trials

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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: NCT06299943 Recruiting - Stroke Clinical Trials

Biofeedback Gait Training by Target Biomechanical Parameters in the Early Recovery Period of Stroke

TargetGait
Start date: January 24, 2022
Phase: N/A
Study type: Interventional

Single-blinded controlled clinical trial. Biofeedback training courses based on target biomechanical gait parameters are being studied. For targeted biofeedback training, various biomechanical parameters are used: parameters of the gait cycle, EMG or kinematics of joint movements. The number of sessions is 8-11 for each patient. Clinical gain analysis is carried out before and after a course of training. Changes in biomechanical parameters that occurred at the end of the training course are assessed in comparison with those before training, and both statuses (before and after training) are compared with similar gait parameters in a group of healthy adults.

NCT ID: NCT06288217 Recruiting - Stroke, Ischemic Clinical Trials

Non-invasive Trigeminal and Vagus Nerve Stimulation for Stroke Subjects With Chronic Upper Extremity Deficits

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

This is a single-center, pilot study of up to 25 subjects with residual upper extremity deficits at least six months after an ischemic stroke. The purpose of the study is to evaluate the initial clinical safety, device functionality, and treatment effect of non-invasive electrical stimulation of the trigeminal and/or vagus nerves (nTVNS) using the NeuraStasis Stimulator System adjunctive to rehabilitation. Subjects will either receive the intervention or control-sham stimulation. The study will inform the design and implementation of a pivotal study.

NCT ID: NCT06230796 Recruiting - Clinical trials for Hemiparesis;Poststroke/CVA

Effects of Functional Electrical Stimulation Assisted Cycling in Patients With Hemiparesis After Stroke

AVCyclES
Start date: November 17, 2023
Phase: N/A
Study type: Interventional

To determine whether active cycling assisted by functional electrical stimulation (FES) Is more effective than active cycling on cardiovascular fitness in post stroke hemiparesis

NCT ID: NCT06179745 Recruiting - Stroke/Brain Attack Clinical Trials

BCI Driving FES and Hand Orthosis for Upper Limb Rehabilitation in Chronic Stroke

Start date: March 14, 2022
Phase: N/A
Study type: Interventional

Multi-center, randomized, sham-controlled, double-blind, longitudinal, experimental clinical study to investigate functional recovery effects on the upper limb in chronic stroke patients and the accompanying neural plasticity mechanisms after the application of a brain-computer interface (BCI)-driven functional electrical stimulation (FES) therapy supported by an assistive device (hand orthosis). All the equipment used during the study will be applied in compliance with the indications and methods of use for which it is authorized. Therefore, the results will not extend the indications for the use of the equipment and will not explicitly target industrial development. The study is non-profit and is aimed at improving clinical practice. The study involves two clinical centers. The promoting center is the Vipiteno Neurorehabilitation Department, Italy. The aggregate experimentation center is the Neurology Department of Hochzirl Hospital, Austria. The University of Essex, United Kingdom is the technology provider and data analysis center.

NCT ID: NCT06164912 Recruiting - Stroke Clinical Trials

Investigating the Use of a Brain-computer Interface Based on TMS Neurofeedback for Upper Limb Stroke Rehabilitation

Start date: June 1, 2023
Phase: Phase 1
Study type: Interventional

The mechanisms and effectiveness of a technique to boost the brain's recovery mechanisms will be studied. Brain-Computer Interface (BCI),based on applying magnetic pulses (Transcranial Magnetic Stimulation, TMS) to the stroke damaged area in the brain, causing twitches in the paralysed muscles will be used. The size of these twitches are then displayed to the patient as neurofeedback (NF) on a computer screen in the form of a game. In the game, the aim for the patient is to learn how to make the twitches bigger by engaging appropriate mental imagery to re-activate the damaged brain region.

NCT ID: NCT06140381 Recruiting - Clinical trials for Hemiparesis;Poststroke/CVA

Strengthening in Sub-acute Stroke Survivors: A Randomized Controlled Trial

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to compare between Eccentric training and conventional therapy in sub-acute stroke survivors. The primary objective of this study is to evaluate improvements in gait speed after four months of ET in comparison to conventional therapy for patients with sub-acute stroke. Secondary objectives involve assessing: i) modifications in neuromuscular parameters of PF, ii) changes in muscle stiffness within PF during passive mobilization and active force generation, and iii) modifications in architectural parameters of PF.

NCT ID: NCT06109194 Recruiting - Clinical trials for Hemiparesis;Poststroke/CVA

Immediate Effect of Ankle Mobilization on Active Range of Motion and Gait in Subacute Stroke

Start date: December 19, 2023
Phase: N/A
Study type: Interventional

The goal of this observational study is to determine the effect of ankle joint mobilization on active range of motion and gait in subacute first-time stroke. The main questions it aims to answer are: - What is the effect of ankle joint mobilization on active range of motion in the ankle and gait qualities? - What is the effect of ankle joint mobilization on self-perceived gait ability? Participants will receive physical therapy interventions of: - Grade III ankle joint mobilization - stretching of ankle plantarflexor muscles - ankle muscle activation training - assisted gait as part of assessment Study design is to measure conditions before and after the intervention to determine effect(s) of one treatment dose, completed within one session of 90 minutes.

NCT ID: NCT06107010 Recruiting - Stroke, Acute Clinical Trials

Effects of Atalante Exoskeleton on Gait Recovery in Non- or Poorly Ambulatory Patients With Hemiparesis in the Acute/Subacute Phase (Month 1 to 4)

EarlyExo
Start date: June 12, 2023
Phase: N/A
Study type: Interventional

The present clinical investigation - EarlyExo, is an interventional, international, multicentric, prospective, single-blinded randomized controlled trial. This clinical investigation is designed to test the hypothesis that early and intense introduction of walking sessions assisted by the Atalante exoskeleton, in a sample of hemiparetic patients with still non or poor ambulatory capacities (FAC 0 or 1) between one- and four-months post stroke, would result in a better recovery of functional walking compared to a control group only receiving conventional therapy. Improved recovery will be measured through the proportion of patients reaching a FAC score of 4 or higher at the end of the intervention period. The tested hypothesis is that this proportion will be higher in the Exo group. The duration of the intervention period in both groups is 6 weeks. - For the Exo group: 3 sessions per week (i.e., 18 one-hour sessions) with the Atalante device and 2 sessions per week (i.e., 12 one-hour sessions) of conventional therapy. - For the Control group: 5 sessions per week of conventional therapy (i.e., 30 one-hour sessions). The study will include 66 patients (33 in each arm) and takes place in two French centers, two German centers and one Spanish center.