None listed
Conditions
Brief summary
Stroke is one of the main causes of disability and mortality in the world by acting not only a significant medical problem but also, due to permanent disability of patients and the costs of their hospitalization, long-term care and rehabilitation, significant economic and social problems. The aim of the study is to evaluate the effect of physiotherapy of the upper limb in patients with stroke injecting botulinum toxin based on clinical trials and stabilometric platform. Patients will be recruited from the general population through local medical centers. They will be randomly divided into a control group and intervention group. Patients in the intervention group will be submitted to 6 cycles of intramuscular injections of botulinum toxin. Subsequent injections of Botox will be performed every 12 weeks. Each time, after 3 weeks of administration, patients will take part in the ongoing three weeks of individual therapeutic exercise program. Patients in the control group will be injected with botulin toxin only once and after 12 weeks they will be evaluated again..
Interventions
Therapeutic management will be carried out by a multidisciplinary team of doctors and physiotherapists. Treatment consisted of the procedure will be described below multifactorial as "combination therapy." To monitor adherence it will be used register of attendance at injection and exercise sessions. Combination therapy will consist of the following interactions; 1. Injection preparation of botulinum toxin type A 2. Movement Therapy Patients will be injected a preparation of botulinum toxin type A. In controlled clinical trials, patients are administered a dose of the product in the dimension of 100 units. The muscles chosen to receive botox and the dose delivered to each of those muscles is determined at the clinical discretion of the treating neurologist based on severity of symptoms in each muscle. They will be divided between the occupied muscle groups and served during one procedure under the control of ultrasound. The dose of botulinum toxin will be divided between the following structure of the muscle: flexor digitorum profundus (15 - 50 units), flexor digitorum superficialis (15 - 50 units), flexor carpi radialis (15 - 60 units), flexor carpi ulnaris (10 -50 units) flexor pollicis longus (20 units), biceps brachi (50 - 100 units). Injections will always be made by the specialist neurologist at the clinical discretion of the treating neurologist based on severity of symptoms in each muscle. Eligible patients for the research program will be submitted to 6 administrations of botox, occurring every 12 weeks. Each time, after 3 weeks after each botox administration, patients will take part in the ongoing three weeks of individual therapeutic exercise program (3 weeks x 5 days per week x 90 minutes) at the study site. Study participants will be evaluated clinically at the time they qualify for each of the six stages of the research program and after completion of each. During the 3 weeks movement therapy, participants will be required to attend physical therapy 5 days a week. Each session will be lasted 90 minutes. It will start with 30 min long term elongation of upper limb with use of splints. Then will be 10 min introductory part including warm-up mobilization of joint structures, nerve, muscle and fascial. After the introductory part followed will be 40 minutes of the main part of which included will be active: active exercises of healthy upper limb during supporting on hemi upper limb, active exercises of hemi upper limb in closed kinematic inhibition of associates reactions, exercise of daily activities (ie .: grasp a bottle of water, a cup, a towel, dressing up). Therapy will be completed 10 minutes of relaxing exercises. It will be individual sessions with physiotherapist.
Sponsors
Study design
Eligibility
Inclusion criteria
documented hospitalization due to stroke occurring post-stroke spasticity of the upper limb (MAS greater than 2 or equal to 2) at least in the one group of muscle set deadline for rehabilitation no later than three weeks after the Botox injection
Exclusion criteria
severe swallowing disorders and respiratory disorders, pregnant or breast-feeding, myasthenic syndrome, taking medicines that inhibit neuromuscular transmission (eg. aminoglycosides) general symptoms of infection, presence of inflammation in the intended site of injection,does not apply to patients who take acenocoumarol or warfarin and on the day of administration, the INR exceeds 2.5, dementia (MMSE test < 18 pts) - does not apply to patients with aphasia, alexia or agraphia who take acenocoumarol or warfarin and on the day of administration, the INR exceeds 2.5, settled contraction of the upper limb or muscle atrophy in the hemi upper limb, hypersensitivity to neurotoxin complex or any of the ingredients of botulinum toxin type A BOTOX A who experienced serious side effects after injection of the drug, baclofen pump, paralysis of the hemi upper limb