RECRUITINGINTERVENTIONAL

A Head-to-head Study Comparing the Functional Value of Two Models of Robotically Assisted Rehabilitation in SMA (Spinal Muscular Atrophy) Patients

A Head-to-head Study Comparing the Functional Value of Two Models of Robotically Assisted Rehabilitation in SMA Patients: Single-center, Randomized, Single-blinded, Comparative Study of a Robotically Active Verticalization Model Versus Robotically Assisted Locomotion Model

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - Signing of willing to sign a consent form 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. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

PROCEDURE

Robotically Assisted Locomotion

* Motor control training * Locomotion and motor control training with elements of balance and coordination * Verticalization training: standing frame device and vibration platform * Cognitive therapy

PROCEDURE

Robotically Assisted Verticalization

* Motor control training * Verticalization training with Standard Frame Devices * Locomotion and motor control training with elements of balance and coordination * Cognitive therapy

Locations (1)

Wiktor Dega University Orthopedic and Rehabilitation Hospital

Poznan, Poland