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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
200
* Motor control training * Locomotion and motor control training with elements of balance and coordination * Verticalization training: standing frame device and vibration platform * Cognitive therapy
* Motor control training * Verticalization training with Standard Frame Devices * Locomotion and motor control training with elements of balance and coordination * Cognitive therapy
Wiktor Dega University Orthopedic and Rehabilitation Hospital
Poznan, Poland
RECRUITINGClinical assessment of patients using Children's Hospital Of Philadelphia Infant Test Of Neuromuscular Disorders, Revised Upper Limb Module, Hammersmith Functional Motor Scale
Time frame: Through study completion, max. for 2.5 year every 6 months
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.
Time frame: Through study completion, max. for 2.5 year every 6 months
Functional assessment of patients using GMFM (Gross Motor Function Measure) scale
Time frame: Through study completion, max. for 2.5 year every 6 months
X-ray or ultrasound scan imaging assessment of the spine, hip joints and bone mineral density
Time frame: Once per 1 year
Assessment of the quality of life of patients and their caregivers using Pediatric Quality of Life Inventory ver. 4.0
Time frame: Through study completion, max. for 2.5 year every 6 months
Hospitalization during or between rehabilitations that take place each 6 months
Time frame: Through study completion, max. for 2.5 year
Occurence of discomfort during therapy requiring abrupt interruption or significant modification
Time frame: Through study completion, max. for 2.5 year every 6 months
Number of fractures
Time frame: Through study completion, max. for 2.5 year
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