Compares two robot-assisted rehabilitation methods for children and young adults with SMA
Compares two robot-assisted exercise methods, standing and walking, in people with SMA.
Plain-language title generated from the registry record
Registry title: A Head-to-head Study Comparing the Functional Value of Two Models of Robotically Assisted Rehabilitation in SMA (Spinal Muscular Atrophy) Patients
Key facts
- Where
- Poznan, PolandSee the site
Where in Poland
- Wiktor Dega University Orthopedic and Rehabilitation HospitalPoznan, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Wiktor Dega University Orthopedic and Rehabilitation Hospital
- Trial code
- NCT06322654
- Record updated
- 21 March 2024
- Original description
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.Read full original descriptionShow less
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
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
Inclusion: 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: Advanced osteoporosis with multiple fractures prior to treatment; Cardio-respiratory disorders requiring invasive ventilation; 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.