None listed
Conditions
Brief summary
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 3 cycles of intramuscular injections of botulinum toxin. Each time, after 3 weeks of administration, patients will take part in the ongoing three weeks of individual therapeutic exercise program.
Interventions
One cycle of combination therapy will last for 6 weeks. After completing the first stage, patients will be qualified to participate in the next cycle of therapy. Between the successive stages there will be a break of 9 weeks. Patients qualified to participate in the program will take part in three such cycles. The total time of participation in the study will be 12 months. 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 of lower limb will consist of the following interactions; 1. Injection preparation of botulinum toxin type A (intramuscular injection) 2. Movement Therapy Patients will be injected with Botulinum toxin a three times over a period of 12 months. 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 drug will be administered in muscle (intramuscular injection): a) gastrocnemius muscle, medial head (75 units) b) calf muscle, lateral head (75 units) c) soleus muscle (75 units) d) tibialis posterior (75 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 3 administrations of botox. 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 60 minutes) at the study site at The University of Physical Education. Study participants will be evaluated clinically at the time they qualify for each of the three 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 60 minutes. The first part of the training program consists of a short 10 minute warm-up of simple whole body exercises (marching, arm swings, standing with hands on knees making circular movements) followed by gentle stretching exercises (e.g., calf muscle stretch, hamstring muscle stretch, thigh muscle stretch, trunk side stretch). After the warm-up, the major components address for example: functional strengthening, balance and agility exercises, cardiovascular exercises and transfer. Functional strengthening involves tasks that address muscle weakness through repetitive coordinated movements that challenge lower limb muscles. Altered motor coordination is evident following a stroke and improvements in movements can be accomplished by utilizing functional movements and postures under challenging conditions. Thus, most of the functional strengthening exercises are done in standing which has advantages in forcing weight-bearing and muscle activity through the limb affected by the stroke. Balance and agility exercises include slow and fast movements. It stimulates the centre of mass to be moved to extents over the base of support. Faster movements (e.g, quick step in different directions) improve the rate of voluntary movement and the ability to weight-bear on the paretic limb. Another component focuses on aerobic fitness. Many activities overlap into all of these components. For example, fast walking and walking with longer than usual steps were used as part of the aerobic component, but these tasks will also strengthen plantarflexor and hip flexor muscle activity, in addition to agility. Lastly, a short cool-down can replicate some of the stretching performed during the warm-up.. It will be individual sessions with physiotherapist.The program will be adapted to the individual needs and capabilities of each patient.
Sponsors
Study design
Eligibility
Inclusion criteria
a) aged grater than 50 less than 65, b) after ischemic stroke in a period of at least 3 months before inclusion in the program, and no later than 5 years after the stroke, c) confirmed post-traumatic spasticity of the lower limb - moderate or higher degree (result in the modified Ashworth scale MAS equal to or greater than 2) d) capable of independent passage of 20 m (only orthopedic supplies in the form of an AFO or DAFO orthosis are allowed).
Exclusion criteria
a) severe dysphagia or respiratory disorders, b) pregnancy c) myasthenia and myasthenic syndrome - based on neurological examination d) symptoms of generalized infection, e) the presence of inflammation f) permanent contractures in soft tissues and joints, g) paralysis of the lower limb, h) pusher syndrome i) cognitive disorders - MMSE (Mini-Mental State Examination <18), j) co-morbidities that disturb the gait pattern (eg osteoarthritis).