Spasticity, Muscle

13

Review clinical trials related to Spasticity, Muscle. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Does ESWT With BoNTA Treatment Improve Outcomes When Compared to Standard Management for Upper Limb Spasticity Patient.

Background Effective management of spasticity, a debilitating and challenging condition afflicting many recovering from and living with neurological conditions, may reduce long term consequences such as limb contracture, skin breakdown, compromised mobility, caregiver burden and discomfort. In rehabilitation, spasticity represents a significant barrier to successful rehabilitation outcomes. Effective spasticity management can increases the length of individual functional status, reduces equipment/care needs, hospital admissions and extends the time people can stay safely at home, which would represent an economic benefit to the health system. Extra-corporeal Shock Wave Therapy (ESWT), an intense short energy wave delivered directly at the region of affected muscles has, in past randomized controlled studies, demonstrated positive outcomes for this population (spastic stroke population, TBI), on its own and as an adjunct to current modalities. In fact, one retrospective observational study demonstrated an increased efficacy of Toxin botulinum at 1 month when combined with ESWT. Where existing treatment options may be limited by coverage, access to delivery, complications and side effects, ESWT represents a potential to be a safe, low cost, efficacious alternative that can be administered by any trained clinician. Aims The aims of this pilot study will be to explore the hypothesis that adding ESWT to Botulinum Neurotoxin A (BoNTA) in spasticity post-stroke (TBI)will demonstrate greater clinical and patient reported outcomes compared to standard treatment with BoNTA alone, a comparison only once previously studied. Methods Incorporating randomization and placebo control (n= 20 in each arm), this patient-centric study will examine treatment goals and holistic perception of benefit after the treatment experience. We will use patient reported outcomes at baseline and at defined intervals after intervention. We will test our hypothesis using clinical and patient reported scales, such as the patient reported numeric rating scale (NRS) and goniometric range for spasticity as our primary outcome in conjunction with measures of muscle stiffness, quality of life, feasibility and acceptability of the protocol to help inform future study direction.

Participants needed: 40
Trial details
Age: 18-99Biological sex: AllType: InterventionalSponsor: University of AlbertaUpdated: Apr 13, 2026Locations: 1
Eligibility criteria

Acquired brain injury (of at least 1 year following the event); [+10]

Known neurodegenerative disorder at the spinal level; [+15]

Status: Recruiting

Hereditary Spastic Paraplegia Genomic Sequencing Initiative (HSPseq)

The purpose of the HSP Sequencing Initiative is to better understand the role of genetics in hereditary spastic paraplegia (HSP) and related disorders. The HSPs are a group of more than 80 inherited neurological diseases that share the common feature of progressive spasticity. Collectively, the HSPs present the most common cause of inherited spasticity and associated disability, with a combined prevalence of 2-5 cases per 100,000 individuals worldwide. In childhood-onset forms, initial symptoms are often non-specific and many children may not receive a diagnosis until progressive features are recognized, often leading to a significant diagnostic delay. Genetic testing in children with spastic paraplegia is not yet standard practice. In this study, the investigators hope to identify genetic factors related to HSP. By identifying different genetic factors, the investigators hope that over time we can develop better treatments for sub-categories of HSP based on cause.

Participants needed: 200
Trial details
Age: 1-30Biological sex: AllType: ObservationalSponsor: Boston Children's HospitalUpdated: Mar 18, 2026Locations: 1Duration: 5 Years
Eligibility criteria

Clinical diagnosis of progressive spasticity

Status: Recruiting

Radiosurgery Treatment for Spasticity Associated With Stroke, SCI & Cerebral Palsy

A scientific study is being done to test a special treatment for people who have spasticity or tight muscles. This treatment is called "stereotactic radiosurgery dorsal rhizotomy." It uses very accurate beams of radiation to target certain nerves in the back to help loosen up the muscles. In this study, people are put into two groups by chance: one group gets the real treatment, and the other group gets a "fake" treatment that doesn't do anything. This fake treatment is called a "sham." Doing this helps make sure the study is fair and the results are true. After the people in the study get their treatment, the researchers will watch and see how they do. They will check if their muscles are less stiff and if they have any side effects. By looking at the results from both groups, the researchers can find out if the special treatment really helps people with spasticity. Patients who got the "fake" treatment will be eligible to receive the "real" treatment after 6 months.

Participants needed: 22
Trial details
Age: 16+Biological sex: AllType: InterventionalSponsor: Ohio State UniversityUpdated: Dec 19, 2025Locations: 2
Eligibility criteria

Chronic spasticity refractory to medical management or in a patient who cannot r... [+1]

Inability to lie supine for simulation & treatment [+2]

Status: Recruiting

Operant Conditioning of Spinal Reflexes Training System--Reflex Operant Down Conditioning

The purpose of this study is to validate the capacity of a reflex training system to change the size of the targeted reflex. For this, the researchers are recruiting 25 individuals with chronic incomplete SCI who have spasticity in the leg to participate in the reflex training procedure. The study involves approximately 45 visits with a total study duration of about 6 months.

Participants needed: 25
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Medical University of South CarolinaUpdated: Sep 9, 2025Locations: 2
Eligibility criteria

a clinically stable spinal cord injury (above T11) that occurred at least one ye... [+6]

motoneuron injury; [+9]

Status: Recruiting

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

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.

Participants needed: 40
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: National Taiwan University HospitalUpdated: Jul 29, 2025Locations: 1
Eligibility criteria

Individuals aged 18 years or older with unilateral cerebral stroke. [+3]

History of more than one stroke, traumatic brain injury, or cerebral neoplasm. [+4]

Status: Recruiting

Investıgatıon Of The Effectıveness Of The Mollıı Suıt In Chıldren Wıth Ambulatory Cerebral Palsy

Cerebral Palsy (CP) is the most common developmental disorder in childhood. Individuals' independence in daily living activities and participation in education, games, social and community activities are restricted. Technology applications in the field of rehabilitation are gaining momentum. EXOPULSE Mollii Suit method, one of the newest rehabilitation technology products, is a non-invasive neuromodulation approach with a garment that covers the whole body and electrodes placed inside. Designed to improve motor function by reducing spasticity and pain, the method is based on the principle of reciprocal inhibition, which occurs by stimulating the antagonist of a spastic muscle at low frequencies and intensities. Therefore, the aim of our study is to examine the effectiveness of the Mollii Suit application on gross and fine motor function, spasticity severity, balance, walking, selective motor control, postural control, daily living activities, quality of life, pain and sleep quality in individuals with ambulatory spastic CP.

Participants needed: 32
Trial details
Age: 4-18Biological sex: AllType: InterventionalSponsor: Kastamonu UniversityUpdated: Jul 11, 2025Locations: 1
Eligibility criteria

Being a voluntary participant in the study, [+4]

Being between 4-5 on Gross Motor Classification System (GMFCS) [+3]

Status: Recruiting

Study of Brain-spinal Cord Neural Connectivity in Spasticity

Little is known about the peripheral and central mechanisms of action of selective dorsal rhizotomy surgery for the treatment of spasticity. A better understanding of these mechanisms will enable us to improve the surgical procedure. This will require cortico-medullo-radiculo-muscular recordings never before performed and published in the literature, and the identification of variations in connectivity correlated with the clinic.

Participants needed: 50
Trial details
Age: 3-17Biological sex: AllType: ObservationalSponsor: Fondation Ophtalmologique Adolphe de RothschildUpdated: Jun 11, 2025Locations: 2
Eligibility criteria

Patients aged 3 to 17 years included [+3]

Contraindications to selective rhizotomy [+4]

Status: Not yet recruiting

Vibrotactile Coordinated Reset for Spasticity After Spinal Cord Injury

The purpose of our study is to evaluate vibrotactile Coordinated Reset (vCR) and its effects on spasticity symptoms in incomplete spinal cord injured patients. vCR will be administered with a device called the Stanford CR Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as oral baclofen and or deep brain stimulation. Patients will be followed for three months and will be asked to come to the lab for clinical testing 4 times during this period. A total of 30 patients will be included in the study.

Participants needed: 30
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Stanford UniversityUpdated: May 15, 2025Locations: 1
Eligibility criteria

Age at the time of enrollment: Any adult ages 18 and over [+9]

Sensory deficits in palma manus resulting in missing inter digit discrimination... [+11]

Status: Recruiting

Melpida: Recombinant Adeno-associated Virus (serotype 9) Encoding a Codon Optimized Human AP4M1 Transgene (hAP4M1opt)

MELPIDA is proposed for the treatment of subjects with SPG50 and targets neuronal cells to deliver a fully functional human AP4M1 cDNA copy via intrathecal injection to counter the associated neuronal loss. Outcomes will evaluate the safety and tolerability of a single dose of MELPIDA, which will be measured by the treatment-associated adverse events (AEs) and serious adverse events (SAEs). Secondarily, the trial will explore efficacy in terms of disease burden assessments.

Participants needed: 4
Trial details
Phase: Phase 1, Phase 2Age: 4-10Biological sex: AllType: InterventionalSponsor: Elpida Therapeutics SPCUpdated: Oct 8, 2024Locations: 1
Eligibility criteria

Age 4 months-10 years old [+7]

Inability to participate in study procedures (as determined by the site investig... [+13]

Status: Recruiting

Extracorporeal Shock Wave Therapy on Spastic Equinus Foot in Stroke Patients

The goal of this study is to evaluate long term effects of focused extracorporeal shock wave therapy (fESWT) on triceps surae spasticity in stroke patients according to the number of sessions applied. Hypothesis: 3 sessions of fESWT on equinus foot in stroke patients improve spasticity and functionality for longer term than 1 session of fESWT.

Participants needed: 60
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Teresa Mateu CamposUpdated: Sep 19, 2024Locations: 1
Eligibility criteria

Age greater than 18 years old [+3]

Fixed ankle joint contracture [+3]

Status: Not yet recruiting

Identification of Sodium Channel Fragments as Serum Biomarkers of a Traumatic Central Nervous System Injury

Following spinal cord injury (SCI), 75% of patients develop spasticity of the limbs characterized by an increase in muscle tone causing severe pain. Currently, the diagnosis of spinal cord injury is based on clinical and radiological evaluation by CT and MRI, but there is no reliable biomarker capable of predicting the medium and long-term clinical course in terms of emergence and severity of spasticity and neurological recovery. Recently, pre-clinical models in rats have shown the presence of protein fragments from a cleavage of sodium channels in spinal cords below the level of injury. Other studies have also shown the presence of these fragments in the brain following a head injury. These fragments would be potentially useful as a biomarker of the SCI. The detection of sodium fragments would be potentially useful as a biomarker of a lesion of the central nervous system (spinal cord or brain) and of the severity of the spasticity in patients suffering from SCI. The main objective of this study is to detect the presence of sodium fragments in blood samples from patients with SCI from or brain injury. The secondary objectives will be to study the post-lesional / injury kinetics of sodium fragments, to determine their diagnostic values in terms of the severity of the injury, and their prognostic values concerning the emergence of the spasticity in patients with SCI. An initial prospective cohort will include 40 people. The fragments of sodium channels will be measured in blood samples taken within 6 hours post-trauma, then 1, 3, 5 and 7 days post-trauma, as well as 3 and 6 months post-trauma. The overall expression of sodium fragments will be compared to that of healthy controls. Participants will be recruited in the acute care units of the AP-HM. Participants will be recruited from the main acute care units of the AP-HM. Post-traumatic follow-up assessments during their rehabilitation will be carried out at 3 and 6 months in the neurosurgery department of North Hospital from APHM.

Participants needed: 40
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: Assistance Publique Hopitaux De MarseilleUpdated: Aug 1, 2024
Eligibility criteria

Age 18 to 75 [+3]

Pregnant or breast-feeding women [+26]

Status: Recruiting

Obturator Cryoneurotomy for Hip Adductor Spasticity

The purpose of the study is to measure the effects of obturator nerve cryoneurotomy, on clinical measures in adult (ages 19+) and paediatric (ages 12-18) patients with hip adductor spasticity, who will receive this procedure as a part of their treatment based on the spasticity treatment available guidelines. The results will provide us valuable information like how long cryoneurotomy is effective, before regeneration happens

Participants needed: 20
Trial details
Age: 12+Biological sex: AllType: ObservationalSponsor: Vancouver Island Health AuthorityUpdated: Jun 14, 2024Locations: 1
Eligibility criteria

Will have cryoneurotomy as part of their standard treatment for spastic hip addu... [+3]

Have a history of previous nerve procedures such as chemical neurolysis with alc... [+1]

Status: Recruiting

The Muscle in Cerebral Palsy; Sarcomere Length in Vivo and Microscopic Characterization of Biopsies.

Cerebral palsy (CP) is a motor impairment due to a brain malformation or a brain lesion before the age of two. Spasticity, hypertonus in flexor muscles, dyscoordination and an impaired sensorimotor control are cardinal symptoms. The brain lesion is non-progressive, but the flexor muscles of the limbs will during adolescence become relatively shorter and shorter (contracted), forcing the joints into a progressively flexed position. This will worsen the positions of already paretic and malfunctioning arms and legs. Due to bending forces across the joints, bony malformations will occur, worsening the function even further. Currently, the initial treatment of choice is the use of braces, which diminishes the shortening somewhat, but eventually lengthenings of tendons and release of aponeuroses around the muscles often is needed, and transfers of wrist flexors to wrist extensors may improve wrist position. But the long-term results are unpredictable- how much does the muscle need to be lengthened? What muscles should be transferred for a better position of the wrist, and at what tension? A method to measure sarcomere length in vivo has been developed. The sarcomere, the distance between two striations, is the smallest contractile unit in the striated muscle. When, during surgery, a muscle fiber bundle is transilluminated with a low energy laser light, a diffraction pattern is formed. This diffraction pattern reflects the sarcomere length, and thereby an instant measure of how the stretch of the muscle is obtained. When performing tendon transfers of e.g. wrist flexors to wrist extensors, the setting of the tension of the transfer is arbitrary, and the long-term result is unpredictable. Laser diffraction measurements will give a guide to a precise setting of tension. It is known that there may be pathological changes in muscle in cerebral palsy that also will affect the long-term results of tendon lengthenings and transfers. In order to also take these changes into account, small muscle biopsies will be taken during the same surgeries. These will be examined with immuno-histochemical and biochemical techniques, gel-electrophoresis as well as electron microscopy.

Participants needed: 150
Trial details
Age: 2-18Biological sex: AllType: ObservationalSponsor: Eva PontenUpdated: Aug 26, 2022Locations: 3
Eligibility criteria

Celebral Palsy or Aquired Brain Injury

Progressive neurological disease