Actively Recruiting
A Head-to-head Study Comparing the Functional Value of Two Models of Robotically Assisted Rehabilitation in SMA (Spinal Muscular Atrophy) Patients
Led by Wiktor Dega University Orthopedic and Rehabilitation Hospital · Updated on 2024-03-21
200
Participants Needed
1
Research Sites
184 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Head-to-head Study Comparing the Functional Value of Two Models of Robotically Assisted Rehabilitation in SMA (Spinal Muscular Atrophy) Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent by participant or legal guardian
- Confirmed diagnosis of spinal muscular atrophy (types 1-4) by genetic testing, symptomatic or pre-symptomatic
- Age between 0 and 21 years at study start
- Currently receiving drug treatment for spinal muscular atrophy at eligibility
You will not qualify if you...
- Cardio-respiratory disorders needing invasive ventilation
- Advanced osteoporosis with multiple fractures before treatment
- Functional decline during rehabilitation as measured by SMA-specific scales
- Lack of cooperation with therapist
- Other functional issues preventing exercise
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Wiktor Dega University Orthopedic and Rehabilitation Hospital
Poznan, Poland, 61-545
Actively Recruiting
Research Team
M
Marek Jóźwiak
CONTACT
R
Radosław Rutkowski
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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