Early Use of Botulinum Toxin in Spasticity Post Stroke.
StrokeMuscle Spasticity1 morePatients who survive a stroke are often left with an arm that cannot be used. One reason for this is that the muscles affected by the stroke become overactive. This is known as spasticity. Such unwanted muscle overactivity, if left untreated or poorly managed, can lead to limb deformities. For example, the wrist and fingers in the arm affected by spasticity become stiff and curl into a fist and the hand cannot be used for any functional purpose. Palm hygiene can become difficult and patients find this deformity unsightly and painful. Botulinum toxin (BT) has been shown to reduce muscle overactivity and is licensed for this purpose. In current practice this treatment is often used as a last line of defence. Although BT can reduce the muscle overactivity, when injected using current protocols, it seems to have little impact on the recovery of function and/or treating the limb deformities and pain. If BT can be given in the early stages of a stroke, i.e. as soon as the muscle overactivity is observed, then we will be able to treat spasticity and may prevent the limb deformities and pain from developing. We may also be able to assist the recovery of arm movement in some of the patients who would otherwise not have regained this. In addition to benefiting the patient, the prevention of secondary complications by early treatment may reduce the costs of long term care to the NHS . We hope to discover if our plan of providing early treatment with BT is more effective than the current approach. If we demonstrate that the treatment is effective we will be able to introduce this new method almost immediately within the NHS through our collaboration with doctors and therapists who are actively treating patients with this condition.
Shockwaves Therapy and Botulinum Toxin for the Treatment of Spasticity in Patients With Cerebral...
SpasticityCerebral PalsySpasticity is a motor disorder that can affect the lower limbs in up to 75% patients with cerebral palsy, having a significantly effect on their mobility and quality of life. There is much controversy about what is the most appropriate treatment of spasticity The objective of the present study is to evaluate the effects of radial extracorporeal shock wave therapy (rESWT) compared to treatment with botulinum toxin to improve spasticity in patients with cerebral palsy The number needed of patients is 70 (35 per group). Leaving a period of washout between one therapy and the other
A Study to Evaluate the Botulinum Toxin Type A for Injection(HengLi®) in Subjects With Post-stroke...
Cerebrovascular AccidentThis is a multicenter, double-blind, randomized, placebo-controlled study designed to compare Botulinum Toxin Type A for Injection (HengLi®) with placebo on the efficacy and safety of treatment in post-stroke subjects with focal wrist, finger and in some cases, thumb spasticity. Approximately 180 subjects will be enrolled. The core period of the subjects will receive a single treatment session of intramuscular HengLi® 200U or 240U (if thumb spasticity is present) or placebo in a randomization ratio of 2:1. Research contains two parts: core phase and extension phase. In the core phase, subjects will finish 6 visits (12 weeks ) after initial injection. During the extension phase, subjects will accept two follow-up visit (6 weeks). Outcome measures include changes from baseline at every post injection visit as measured on the Modified Ashworth Scale (MAS), Disability Assessment Scale (DAS) and Global Assessment Scale(GAS). The primary efficacy endpoint is the change from baseline at week 6 for wrist flexor muscle tone as measured on the Modified Ashworth Scale. Safety parameters will also be measured including adverse events, vital signs (pulse and blood pressure) and clinical laboratory tests (haematology, serum chemistry and urinanalysis).
Dysport® Adult Lower Limb Spasticity Follow-on Study
Post-stroke SpasticitySpasticity Post-Traumatic Brain InjuryThe purpose of this research study is to assess the long term safety of Dysport® in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.
The Efficacy and Safety of MEDITOXIN® in Children With Cerebral Palsy
Muscle SpasticityThe purpose of this study is to evaluate the efficacy and safety of Meditoxin® in the treatment of children with cerebral palsy.
Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg...
Post-stroke Spasticity of the Lower LimbThe purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg are effective in treating patients with increased muscle tension/uncontrollable muscle stiffness (spasticity) after a stroke.
Efficacy and Safety Study of Botulinum Neurotoxin A With Rehabilitation Versus Botulinum Neurotoxin...
Upper Limb SpasticityThe purpose of this study is to determine if a combination of botulinum neurotoxin A and rehabilitation therapy is better than botulinum neurotoxin A alone for improvement in function based on the Fugl-Meyer and other validated measures. Hypothesis: The combination of botulinum neurotoxin A and rehabilitation therapy will produce better functional improvement than botulinum neurotoxin A alone in post-stroke upper limb spasticity measured by the Fugl-Meyer Assessment of Sensorimotor Recovery after Stroke.
Botulinum Toxin A Adult Gastrocnemius Muscle Study
Muscle SpasticityStrokeThe study aims to compare the effectiveness of BOTOX-A® (botulinun toxin A) placed between two different injection sites, namely at the proximal portion of the gastrocnemius(GCM) versus at the midbelly of the GCM.
SISTERS: Spasticity In Stroke Study - Randomized Study
Severe SpasticityTo demonstrate that Intrathecal Baclofen (ITB) Therapy, compared to Best Medical Treatment (BMT), has superior efficacy in the treatment of severe spasticity in adult post-stroke patients with generalized spastic hypertonia who have not reached their therapy goal with other treatment interventions assessed by a decrease in the average Ashworth Scale (AS) score in the lower extremities.
BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity
PediatricsMuscle Spasticity1 moreThis study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric lower limb spasticity.