None listed
Conditions
Brief summary
Spasticity is one of the most important causes of disability in stroke patients; it interferes with the patients rehabilitation, especially regarding functional recovery. Spasticity should be appropriately treated because it causes pain , postural abnormality and decreasing in range of movement, thereby hindering patients ability for daily living and affecting the quality of life. The first step in the treatment of spasticity is physical therapy that includes positioning and appropriate exercise programs. Oral anti-spasticity drugs, motor point block using phenol, alcohol and botilinium toxin injection, intrathecal baclofen and surgery can be used for the second step. The necessity of new noninvasive treatment methods for spasticity has been raised because spasiticity can not be controlled sometimes even diverse treatment methods as well as due to the side effects of oral drugs and the invasiveness of local treatment methods. Recently extracorporeal shock wave therapy (ESWT) has been suggested as a non –invasive, alternative treatment of spasticity. The shock waves can be radial or focused . Manganotti demonstrated the safety and effectiveness of a single ESWT session in reducing spasticity of wrist and finger flexors in 20 patients. Within the available literature there are only few studies that investigated the effect of radial ESWT on spasticity in stroke patients. Fauda demonstrated a significant decrease in spasticity of wrist and finger flexor muscles after rESWT. The standard dose, duration and number of sessions of rESWT for the treatment of spasticity has not been fully determined yet. The aim of this study was to evaluate the effectiveness of rESWT in lower extremity plantar flexor spasticity in stroke patients and to reveal the relationship of this effect with the fibroelastic components of the muscle. This study is planned as a single-blind, randomized controlled trial. Stroke patients with ankle plantar flexor spasticity more than grade 1 according to the modified ashworth scale who were hospitalized for inpatient rehabilitation at the Ankara University Faculty of Medicine, PMR Clinic , Patients are assessed to determine their eligibility for the study. All patients who fulfilled the inclusion criteria receive a detailed explanation of the study and written informed consent is obtained from all participants prior to enrollment. Participants are randomly allocated to three groups; the ESWT group, the sham ESWT group and the control group.The primary outcome measure of this study is the grade of the spasticity according to the modified ashworth scale.The primary endpoint of the study is to determine a decrease in spasticity grade at least one point.To determine the fibroelastic components of the spastic muscles, ultrason elastography is used as secondary outcome measure. The secondary endpoint of this study is to provide improvement of the fibroelastic properties and reduction in the stiffness of the spastic muscles.
Interventions
Extracorporeal shock wave therapy (ESWT) is a new technology using a ballistic source to generate pressure waves. The shock waves can be radial or focused. Radial ESWT (rESWT) compared with focused ESWT, is a low to medium energy shock wave with a low penetration power and can be used for the treatment of the large body regions. Recently ESWT has been suggested as a non -invasive, alternative treatment of spasticity. This study is planned as a single-blind, randomized controlled trial. Particip
Extracorporeal shock wave therapy (ESWT) is a new technology using a ballistic source to generate pressure waves. The shock waves can be radial or focused. Radial ESWT (rESWT) compared with focused ESWT, is a low to medium energy shock wave with a low penetration power and can be used for the treatment of the large body regions. Recently ESWT has been suggested as a non -invasive, alternative treatment of spasticity. This study is planned as a single-blind, randomized controlled trial. Participants are randomly allocated to three groups; the ESWT group, the sham ESWT group and the control group. Radial ESWT (rESWT) will be delivered in this study. Both the ESWT groups and the control group will receive a conventional exercise therapy incluiding range of motion and stretching exercise twice a day during their stay in the hospital. The exercise therapy is administered to patients as a part of standard care of stroke rehabilitation during their stay in the hospital.The ESWT group will receive conventional exercise therapy plus radial ESWT (rESWT) two sessions per week for two weeks (total 4 sessions). Each session will last for 2-5 minutes. 1500 shots are delivered to gastrocnemius muscle of the affected side with a frequency of 10 Hz and pressure of 2 Bars. Sham ESWT group will receive conventional exercise therapy plus radial ESWT(rESWT) two sessions per week for two weeks (total 4 sessions). Each session will last for 2-5 minutes. 100 shots are delivered to gastrocnemius muscle of the affected side with a frequency of 1 Hz and pressure of 1 Bar. Intelect RPW Shockwave by Chattanooga Corporation will be used to deliver stimulation to the spastic muscle. Radial ESWT (rESWT) will be delivered to all patients by the same physiotherapist at least 10 years of experience in Department of PMR of Ibni Sina Hospital. The attendence of patients at ESWT sessions will be monitor by his neurorehabilitation team.
Sponsors
Ankara University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Ischemic or hemorrhagic stroke occurring in any time 2. Between 18 and 70 years of age 3. More or equal to Grade 1 spasticity in the affected side gastrocnemius muscle according to Modified Ashworth Scale 4. The general health condition of patient after stroke is stable
Exclusion criteria
1. Patients treated with Botulinum toxin, phenol or alcohol injection for spasticity in the last 6 months 2.Patients with ankle contracture or severe inflammation in treatment sites 3. Patients with cardiac pacemaker 4. Patients with cancer in or around the treatment area 5. Patients with history of previous antispastic surgery interventions in the area of the ankle 6. Patients with changes in the use of oral antispastic medication in the last 6 months 7. Patients with bleeding diathesis 8. Patients with vascular complaints such as deep vein thrombosis, phlebitis, varicose veins in treatment sites
Outcome results
None listed