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Muscle Spasticity clinical trials

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NCT ID: NCT06407921 Not yet recruiting - Clinical trials for Spastic Cerebral Palsy

Whole Body Vibration and BOSU Ball in Spastic Cerebral Palsy

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

Cerebral palsy is a non-progressive neurodevelopmental disorder, also known as littles disease.The most common cause of physical and mental disabilities in the pediatric population. Cerebral means brain and palsy means weakness or problems in muscles. Spastic cerebral palsy is the common type of cerebral palsy characterized by spasticity or high muscle tone, results in stiffness etc. This will be a randomized clinical trial, data will be collected from Sehat medical complex Lahore. Study will be conducted on 62 patients. Inclusion criteria of this study is spastic diplegic CP children with age between 6 to 12 years, with GMFCS level 1 and 2 and those who are able to Walk at least 10m with or without walking aids, able to understand command will be included. Those diplegic spastic CP who have orthopedic intervention/surgery, botulinum toxin injection within past six months, epilepsy and orthopedic conditions or medical problems that prevented children from participating in exercises will be excluded.

NCT ID: NCT06407869 Not yet recruiting - Clinical trials for Spastic Cerebral Palsy

Effects of Functional Progressive Strength Training in Children With Spastic Cerebral Palsy

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

This study focuses on the effects of Functional Progressive Strength Training (FPST) on children with spastic cerebral palsy, a condition characterized by increased muscle tone that affects movement. Spastic cerebral palsy is one type of cerebral palsy, with others including dyskinetic, which involves involuntary movements, and ataxic, which affects coordination. FPST differs from traditional strength training by incorporating exercises that replicate everyday activities to integrate strength use in daily movements. The study uses an experimental design with participants aged 6-12 years, recruited from specialized centers. They are randomly assigned to either a treatment group receiving FPST or a control group receiving standard care. The study aims to measure improvements in gait and mobility, assessed through various tools like step and stride length, cadence, and gait speed, alongside caregiver reports and direct observations. Statistical analyses will determine the effectiveness of FPST in enhancing motor function and walking capacity in these children.

NCT ID: NCT06407856 Not yet recruiting - Clinical trials for Spastic Cerebral Palsy

Dual Task Training in Spastic Cerebral Palsy

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

Cerebral palsy(CP) is a non-progressive disorder, undergoing mishap to the developing brain and it affect a person's ability to move and maintain balance and posture. Old name of CP is "Little's disease". In Spastic diplegic, muscle stiffness is mainly in the legs, with the arms less affected or not affected at all. There could be secondary musculoskeletal problems due to muscle weakness resulting from poor alignment, limited range of motion, and asymmetrical posture. These deformities are negatively affected by biomechanical movements and can affect balance and gait functions. The main goal of rehabilitation in children with cerebral palsy is to restore independent walking. However, children with cerebral palsy have limited mobility, which leads to gait disorders (short steps, slow walking speed, increased swing phase and postural instability). Therefore, it is important to choose an effective training method to improve the balance and gait of children with cerebral palsy. Walking training can help improve muscle tone, postural control and gait function as well as improve muscle strength, endurance, and coordination of the lower extremities. A growing body of evidence supports implementing dual-task gait training for enhancing functional mobility and cognitive performance. This will be a randomized controlled trial, data will be collected from Rising Sun Institute, Mughalpura campus. A study will be conducted on 32 patients. Inclusion criteria of this study is spastic diplegic CP children with age between 6 to 12 years, with GMFCS level 1 to 3 and those who can walk 50 m without mechanical walking aids and maintain standing for more than 5 seconds without falling will be included. Exclusion criteria of this study is low intellectual ability (IQ < 80) and behavioral symptoms which might affect participation in the protocol, none of the children had surgery or botulinum toxin injections during the year prior to the assessment. Group1 will receive conventional therapy for 30 minutes a day, 3 times a week for 8 weeks. And group 2 will receive conventional therapy with dual-task training for 30 minutes a day, 3 times a week for 8 weeks. For the pre- and post-evaluation of all participants Berg balance scale and Gait outcome assessment list-(GOAL) will be used. Data will be analyzed through SPSS version 23.00.

NCT ID: NCT06394310 Not yet recruiting - Multiple Sclerosis Clinical Trials

Dry Needling in Multiple Sclerosis

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

The investigators are doing this study to see if a treatment called dry needling improves muscle spasticity (muscle tightness) in people who have Multiple Sclerosis. Dry needling involves using tiny needles, like those in acupuncture, to target some muscles, like calf muscles. It differs from traditional acupuncture as it focuses on treating or managing muscle spots, aiming to reduce muscle stiffness and pain. Dry needling may offer a minimally-invasive and medication-free approach to improve muscle spasticity. The investigators hope to see if dry needling also helps enhance balance and walking abilities. This might provide potential improvements inoverall mobility and balance.

NCT ID: NCT06384170 Not yet recruiting - Chronic Pain Clinical Trials

Closed Loop Spinal Cord Stimulation for Neuromodulation of Upper Motor Neuron Lesion Spasticity

CLONUS
Start date: July 2024
Phase:
Study type: Observational

Spasticity is characterized by increased muscle tension and is a classic consequence of upper motor neuron (UMN) damage in the central nervous system, such as from stroke or trauma. Clinically, it presents as muscle resistance to passive stretching, along with clasp-knife rigidity, clonus, increased tendon reflexes, and muscle spasms. An imbalance of the descending inhibitory and muscle stretch reflexes is thought to be the cause of spasticity. Post-stroke spasticity is a common condition that occurs in 37.5-45% of cases in the acute stage and 19-57.4% in the subacute stage after a stroke. At 6 months post-stroke, spasticity develops in 42.6-49.5% of cases, and at one year, it affects 35-57.4% of individuals. In patients with cerebral palsy (CP), incidence is almost 80% while in those living with spinal cord injury the number approaches up to 93%. Traumatic brain injury (TBI) patients have a higher prevalence on initial admission to neurorehabilitation but one in three patients will have chronic spasticity. However, the Defense and Veterans Brain Injury Center report a rate of TBIs amongst deployed veterans to be around 11-23% mostly from blast and explosive trauma. There have been studies as early as the 1980s exploring the efficacy of SCS for spasticity control, however, the credibility of many of these studies is constrained due to an incomplete comprehension of spasticity's underlying mechanisms, outdated research methods, and early limitations in implantable device technology. Intrathecal pumps for baclofen have remained as the mainstay for refractory spasticity, however, it comes with associated risks such as chemical dependence leading to acute baclofen withdrawal and requiring frequent refill requirement. Most importantly, it does not yield functional improvement of muscle activity, just suppression of spasticity. Botox is also routinely used but due to heterogeneity in muscle involvement as well as variability in provider skill, results may be inconsistent and short-lasting, requiring frequent clinic visits for repeat injections to the affected muscle groups. SCS may be able to address that gap in spasticity management.

NCT ID: NCT06358976 Not yet recruiting - Clinical trials for Spasticity as Sequela of Stroke

Anti-Spastic Splint With Focal Muscle Vibration for Stroke Hand Spasticity

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

Title: The Effect of Vibrating Splint on Hand Function After Stroke Summary: This study aims to investigate the effectiveness of a vibrating splint in improving hand function and reducing spasticity among individuals who have experienced a stroke. Stroke is a major global health issue, often resulting in long-term disability and impairments in the upper limbs. Spasticity, a common complication of stroke, causes stiffness and involuntary muscle contractions, leading to difficulties in performing daily activities. Current treatment options for spasticity include medications and physical therapy techniques. However, these approaches may have limitations in terms of effectiveness and duration of benefits. Therefore, non-pharmacological interventions are being explored to enhance rehabilitation outcomes. The hypothesis of this study is that the use of a vibrating splint, which applies mechanical vibrations to the hand muscles, will decrease spasticity and improve hand functionality in individuals with chronic stroke. The vibrations from the splint stimulate the sensory receptors in the skin and muscles, leading to muscle relaxation and improved motor control. The study will be conducted as a pilot randomized controlled trial, involving participants who meet specific eligibility criteria. The participants will be divided into three arms, with each arm receiving a different intervention. Outcome measures, including assessments of spasticity, range of motion, pain levels, and functional abilities, will be collected before and after the intervention period. The findings from this study will contribute to the understanding of non-pharmacological approaches in managing spasticity and improving hand function after stroke. If the vibrating splint proves to be effective, it could offer a safe and accessible option for stroke survivors to enhance their recovery and regain independence in daily activities. This research is essential as it addresses the need for more effective interventions for spasticity management and hand rehabilitation after stroke. By providing valuable insights into the potential benefits of the vibrating splint, this study has the potential to improve the quality of life for individuals who have experienced a stroke and empower them to regain control over their hand movements.

NCT ID: NCT06296082 Not yet recruiting - Stroke Clinical Trials

Comparative Study of the Mechanism of Action of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity: a Proof of Concept Controlled Trial

STROKEPOC
Start date: May 1, 2024
Phase: Phase 2
Study type: Interventional

Trial design This study is a protocol of a phase II clinical trial which will be conducted in two countries (Belgium and Spain) to compare the effectiveness of DN and BTX A in reducing post-stroke spasticity in the plantar flexor muscles. This study is a prospective randomized, controlled, multiple-baseline design with blinded assessors. The study will be registered in ClinicalTrials.gov and will have a length of 19 weeks Trial population Inclusion Criteria: 1) aged 18-75 years old, 2) having lower limb post-stroke spasticity in ankle plantar flexors (MAS scores of 1, 1+ and 2); 3) having had a first stroke; 4) having no more than 12 months of evolution since stroke; 5) having no previous Dry Needling (DN) or Botulinum Toxin type A (BTX A) treatment for spasticity; 6) having ankle PROM ≥ 20° (approx.) when the knee is supported in ~30° flexion; 7) being able to walk independently with or without aids. Exclusion Criteria: 1) medical conditions interfering with data interpretation; 2) any contraindication to receiving BTX A or PS treatment; 3) If taking anti-spasticity medications, participants must be on stable medication for at least 3 months prior to the start of the study and neither the dose nor the medication can be changed during the tria Interventions Participants will be randomly allocated to the group receiving a session of BTX A or to the group receiving Dry Needling once weekly for 12 weeks. Blinded evaluators will assess the effects before, during, after treatment, and at 4-week follow-up. The trial will have regular monitoring visits by an independent external monitor to ensure compliance with the protocol and Good Clinical Practices. Monitors may review source documents to confirm accurate data on CRD. The investigator and institution will guarantee direct access to source documents for monitors and regulatory authorities.

NCT ID: NCT06291974 Not yet recruiting - Clinical trials for Cerebral Palsy Spastic Diplegia

Ankle Foot Orthosis on Muscle Activity in Cerebral Palsy

Start date: March 15, 2024
Phase:
Study type: Observational

To compare the effect of solid ankle foot orthosis and ground reaction foot orthosis on the muscle activity in children with spastic diplegic cerebral palsy (Gross Motor Functional Classification Scale III).

NCT ID: NCT06290609 Not yet recruiting - Clinical trials for Spinal Cord Injuries

Vibrotactile Coordinated Reset for Spasticity After Spinal Cord Injury

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

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.

NCT ID: NCT06281223 Not yet recruiting - Spasticity, Muscle Clinical Trials

Study of Brain-spinal Cord Neural Connectivity in Spasticity

MOVE
Start date: March 2024
Phase:
Study type: Observational

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.