None listed
Conditions
Brief summary
Spasticity is the most important cause of disability in stroke patients and it interferes with the patient rehabilitation. Spasticity should be appropriately treated because it causes pain postural problems and decrease in the range of movement, gait problems and negative effect on the quality of life. Spasticity cannot be controlled sometimes by available treatment methods (oral drugs and local treatment method-botulinum toxin injection or physical therapy methods). There is a need of new non-invasive treatment methods for the spasticity treatment. Repetitive peripheral magnetic stimulation (rPMS) is an innovative and minimally invasive treatment option that has been used as a physical therapy agent. It creates a high-intensity electromagnetic field to stimulate muscles or nerves. Unlike electrical stimulation, rPMS can penetrate deeper layers of the muscles. rPMS has been suggested non-invasive, painless, alternative treatment of spasticity. Within the available literature, there are only few studies that investigated the effect of rPMS on spasticity in stroke patients. The standard dose, duration, and the number of sessions of rPMS for the treatment of spasticity has not been clearly determined, yet. The aim of the study is to clinically and electrophysiologically evaluate the effectiveness of rPMS in lower extremity plantar flexor spasticity in stroke patients.
Interventions
Repetitive peripheric magnetic stimulation (rPMS): rPMS is an innovative and minimal invasive treatment option for spasticity. It is a physical therapy method based on the interaction between a high-intensity electromagnetic field and the human body. Electric current passes through a magnetic coil placed in the applicator and creates magnetic field to stimulate muscles or nerves. In the current literature, there are studies using rPMS in the treatment of spasticity caused by many different disea
Repetitive peripheric magnetic stimulation (rPMS): rPMS is an innovative and minimal invasive treatment option for spasticity. It is a physical therapy method based on the interaction between a high-intensity electromagnetic field and the human body. Electric current passes through a magnetic coil placed in the applicator and creates magnetic field to stimulate muscles or nerves. In the current literature, there are studies using rPMS in the treatment of spasticity caused by many different diseases such as stroke, multiple sclerosis, spinal cord injury, and cerebral palsy. In this study, we will use rPMS to reduce spasticity and increase functional capacity of patients in the treatment group. The treatment group will receive a session of 10 minutes each, once a day, 5 days a week for 2 weeks. Thus, all patients in the treatment group will receive ten sessions. rPMS will be done with “BTL-6000 Super Inductive System Elite”. rPMS treatment parameters will be adjusted to use stimulus intensity above the motor threshold determined specifically for each patient, as recommended by the company that developed the device in the treatment of spasticity (frequency modulation: 25-150 Hz - alternative current will be used). All sessions will be done individually and face-to-face by a doctor from the Physical Medicine and Rehabilitation (PMR) Department, who does not know from which group the volunteer is from. Interventions will be made in Neurorehabilitation Unit, Department of PMR, Ankara University. Ten sessions of stretching exercises will be given to all patients, including the control group. Passive stretching exercises will be applied to ankle flexor muscles by a physiotherapist after the rPMS treatment. Each session will last for 15 minutes, and the exercises will be continued once a day, 5 days a week, for 2 weeks. All sessions will be done individually and face to face by the same physiotherapist who is also blind. Interventions will be made in Neurorehabilitation Unit, Department of PMR, Ankara University. There will be double checklists, one to be used by the doctor and the other to be used by the physiotherapist, to monitor adherence to the intervention.
Sponsors
Ankara University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Being diagnosed with stroke according to the definition of the World Health Organization (1989) 2) Being over 18 years old 3) Having a stroke confirmed by Computed Tomography (CT) and Magnetic Resonance Imaging (MRI) 4) Patients with spasticity between 1 and 3 according to the Modified Ashworth Scale (MAS) in the lower extremity plantar flexor muscles 5) Wellness of the patient's general condition after stroke
Exclusion criteria
1) Patients treated with botulinum toxin, phenol, alcohol injection for spasticity in the last 6 months 2) Patients who have previously undergone antispastic surgery to the treatment area 3) Patients with a change in oral antispastic drug use in the last 6 months 4) Patients with fixed ankle contracture 5) Patients with signs of acute inflammation in the treatment area 6) Patients with bleeding diathesis 7) Patients with implanted devices (cardiac pacemaker, cochlear implant, drug pumps) 8) Patients with vascular problems such as deep vein thrombosis, phlebitis, varicose veins, arterial disease 9) Patients with a history of cancer in the treatment area 10) Pregnancy 11) Patients with metal implants in the treatment area 12) Patients with nonunion fractures at the treatment site
Outcome results
None listed