NCT06322654

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Wiktor Dega University Orthopedic and Rehabilitation Hospital · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• SMA

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-12-21
• Primary completion: 2027-03-31
• Completion: 2027-07-01
• First posted: 2024-03-21
• Last updated: 2024-03-21

Locations

1 site across 1 country: Poland