Comparing Two Robotically Assisted Rehabilitation Methods for Children and Young Adults with Spinal Muscular Atrophy SMA

What this Trial Is About

Researchers are comparing two models of robotically assisted rehabilitation to find the best approach for people with spinal muscular atrophy SMA aged 0 to 21 years. This single-center, randomized, single-blinded study aims to determine which rehabilitation model works better depending on the patients age and starting physical abilities. The study plans to include 200 patients, with 100 in each rehabilitation group. The study involves two rehabilitation methods Robotically Assisted Verticalization and Robotically Assisted Locomotion. Both approaches include motor control training, locomotion with balance and coordination exercises, verticalization training using standing frame devices, and cognitive therapy. The trial will last for up to 4 years, with patients randomly assigned to one of the two rehabilitation groups. Participants will undergo regular clinical assessments using several tests including the Childrens Hospital of Philadelphia Infant Test of Neuromuscular Disorders, motor function scales, gait and balance tests, and imaging of the spine and hip joints. Quality of life for patients and their caregivers will also be evaluated. These assessments occur every six months for up to 2.5 years. The study will monitor hospitalizations, discomfort during therapy, and fracture occurrences throughout the trial period.

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