Overview
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.
- Research period: 4 years
- Patients age: 0-21 y.o.
- Group size: 200 patients (100 patients in each group)
- Assignment of patients to study groups in a randomised manner
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Other functional indications preventing exercise