Actively Recruiting
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
Led by Wiktor Dega University Orthopedic and Rehabilitation Hospital · Updated on 2024-03-21
200
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
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 patient's 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 Children's 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.
CONDITIONS
Brief 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...
- Signing informed consent by participant or legal guardian
- Genetic diagnosis of spinal muscular atrophy types 1-4, symptomatic or pre-symptomatic
- Age between 0 and 21 years at study start
- Receiving treatment under a drug program for spinal muscular atrophy
You will not qualify if you...
- Cardio-respiratory disorders requiring invasive ventilation
- Advanced osteoporosis with multiple fractures before treatment
- Functional deterioration during rehabilitation as measured by relevant SMA scales
- Lack of cooperation with therapist
- Other functional conditions preventing exercise
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2.5 years
Participants receive robotically assisted rehabilitation through either the Locomotion model or the Verticalization model, including motor control training, balance and coordination exercises, verticalization training, and cognitive therapy.
Rehabilitation sessions every 6 months
Duration - Up to 2.5 years
Participants undergo clinical and functional assessments, imaging, and quality of life evaluations up to 2.5 years after treatment start to monitor progress and safety.
Assessments every 6 months; imaging once per year
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
R
Radosław Rutkowski
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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