None listed
Conditions
Brief summary
The aim of the study was to assess parametric and clinical effects of a new therapy system dedicated for SM patients, that combines passive robotic rehabilitation with selective magnetic stimulation and electrostimulation, and to compare it with the effects of conventional physiotherapy in SM. Control group K (n = 28) consisted of healthy volunteers (in 46.4% of mental and in 43.6% of physical workers), including 16 women (57.7%, mean age 44.05 ± 1.96) and 12 men (42.3%; mean age 47.83 ± 3.52), the group's mean BMI was 23.87. The volunteers used no medications or orthotics. They also had no injuries, surgeries or addictions in their medical records. The control group received no treatment, but was examined in order to obtain a general profile of a healthy subject that later served for comparisons with pre- and post-treatment results in trial SM groups 1 and 2.
Interventions
MAX system (the robotic exoskeleton): Connected system for passive physical therapy, brain magnetostimulation and body's 3d electrotherapy. The process bases on three paralell therapy activities and takes place simultaneusly during three elements therapy session.
1. Selective transversal magnetic stimulation (Rolland sulcus).
Contralatteral electromagnetic coil is aimed on specific part of patient's head.
2. Body's 16 electrodes TNS - 3d electrostimulation.
This process bases on adhesive gel
MAX system (the robotic exoskeleton): Connected system for passive physical therapy, brain magnetostimulation and body's 3d electrotherapy. The process bases on three paralell therapy activities and takes place simultaneusly during three elements therapy session. 1. Selective transversal magnetic stimulation (Rolland sulcus). Contralatteral electromagnetic coil is aimed on specific part of patient's head. 2. Body's 16 electrodes TNS - 3d electrostimulation. This process bases on adhesive gel electrodes connected to specific maker places over patient's body (both limbs and trunk). 3. Robotic passive limbs rehabilitation. Two motion programs for upper limbs and one program for lower limbs. Motorized exoskeleton consisting of human body frame with mechanically driven sockets for each limb, trunk and head. The whole frame is built in a way to most precisely mimic human position and range of motion. The set of electromotors forces disabled parts of patient's body to conduct passive movement it is unable to make by itself. The process is conducted by a physician - a rehabilitation specialist. The whole procedure bases on the use of an exoskeleton contolled by computer and custom made software. Computer controls all three elements of therapy, coordinating the work of exoskeleton, TNS devices and magnetotherapy equipment. ------------------ Duration of a treatment session - approx. 60 min (once a day for 10 days from Monday to Friday in a rehabilitation clinic in Cieszyn, Poland). The Sclerosis Multiplex group consisted of 56 patients, 15 men and 41 women, mean age 46.7 +/- 1.94 years. The average time between diagnosis and enrollment to this rehabilitation programme was 12.5 +/- 1.52 years (the longest period was 33 years, the shortest 2 years). Before this rehabilitation programme, 8 people did not participate in any medical programme, the rest did (mainly with Betaferon and Copaxone). This general (SM) group was randomly divided into two subgroups: (SM) (1) consisted of 28 people, 7 men and 21 women, mean age 45.85 +/- 1.94 years (50.40 +/- 5.88 for men and 44.05 +/- 1.96 years for women). The average time between diagnosis and enrollment to this rehabilitation programme was 17.39 +/- 1.63 years (the longest period was 33 years, the shortest 5 years). They were treated using "MAX" therapy system. Mechanical therapy consisted of 100 flexion-extension, 100 abduction-adduction repetitions in shoulder joints and 100 abduction-adduction repetitions in hip joints using MAX system (the robotic exoskeleton). What took place at the same time, was 3-D electro-stimulation (TENS 12mA / 10Hz / 55 min) and transcranial magnetic stimulation (1mT / 10Hz / 55 min). (SM) (2) consisted of 28 people, 8 men and 20 women, mean age 41.7 +/- 2.1 for women and 52.5 +/- 2.4 years for men. The average time between diagnosis and enrollment to this rehabilitation programme was 15.8 years. They were treated with magnetotherapy (head: 1mT / 10Hz / 20min), TENS (left and right hand: 12mA / 10Hz / 20 min) and PNF kinesiotherapy (adduction/abduction patterns for upper and lower extremities, chopping, lifting, bilateral patterns for upper extremities, trunk stimulation : erection, elongation, rotation, balancing - 25 min). This group didn't use "MAX" therapy system (the robotic exoskeleton)..
Sponsors
Andrzej Dyszkiewicz
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Patients' main condition was sclerosis multiplex. For the reference group of healthy people, there were no criteria beyond the fact they did not suffer from SM.
Exclusion criteria
Patients with SM who had SM seizure at that timepoint. Oncological patients. Epilepsis. Systemic diseases (RA, SLE, MCTD, vasculitis etc). Tuberculosis and other contagious diseases. Coronar insufficiency (infarct), ventricular arrythmia.
Outcome results
None listed