A head-to-head study comparing the functional value of two models of robotically assisted rehabilitation in patients with SMA. A single-center, randomized, single-blinded, comparative study of Robotically Assisted Verticalization versus Robotically Assisted Locomotion.
The objective of research:
The main goal of the project is to determine the optimal robotically assisted rehabilitation model for people with SMA depending on age and baseline functional status. The study consists of a head-to-head comparison of two rehabilitation models.
1. Research period: 4 years 2. Patients age: 0-21 y.o. 3. Group size: 200 patients (100 patients in each group) 4. Assignment of patients to study groups in a randomised manner
Signing of informed consent to participate in the experiment by the participant or the participant's parent/legal guardian
Diagnosis of SMA (spinal muscular atrophy 1-4) confirmed by genetic testing, symptomatic or pre-symptomatic
Age between 0 and 21 years of age (will be determined on the day of starting participation in the project based on the date of birth)
Treatment under a drug program for spinal muscular atrophy, provided that the patient has a diagnosis of spinal muscular atrophy at the date of eligibility.
Cardio-respiratory disorders requiring invasive ventilation
Advanced osteoporosis with multiple fractures prior to treatment
Functional deterioration during the rehabilitation process in the range of scales appropriately selected for the SMA type: Prechtl, HINE, CHOP-INTEND, HFMS, RULM
Lack of cooperation with the therapist
Parallel
Robotically Assisted Locomotion
Procedure/Surgery* Motor control training * Locomotion and motor control training with elements of balance and coordination * Verticalization training: standing frame device and vibration platform * Cognitive therapy
Robotically Assisted Verticalization
Procedure/Surgery* Motor control training * Verticalization training with Standard Frame Devices * Locomotion and motor control training with elements of balance and coordination * Cognitive therapy
Clinical assessment of patients using Children's Hospital Of Philadelphia Infant Test Of Neuromuscular Disorders, Revised Upper Limb Module, Hammersmith Functional Motor Scale
Clinical assessment of patients using Balance test minimum 1 min., Self-walk test of at least 2 meters, 6-minute gait test, Up&Go test, 10 meters gait test, hip range of motion and muscle strength evaluation.
Functional assessment of patients using GMFM (Gross Motor Function Measure) scale
X-ray or ultrasound scan imaging assessment of the spine, hip joints and bone mineral density
Hospitalization during or between rehabilitations that take place each 6 months
Occurence of discomfort during therapy requiring abrupt interruption or significant modification
Number of fractures
Click on the lead sponsor to view all of their trials.
