Comparing two robotic rehabilitation methods for SMA patients
Official title: 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
Run by Wiktor Dega University Orthopedic and Rehabilitation Hospital · NCT06322654 · Data updated 2026-11-12
This study is testing which of two robotic rehabilitation methods helps young people with Spinal Muscular Atrophy feel and move better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 21 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Wiktor Dega University Orthopedic and Rehabilitation Hospital Academic / other |
| Locations | 1 site (Poznan) |
| Status | Recruiting |
| Started | December 21, 2023 |
| Main results expected | March 31, 2027 |
| Study ends | July 2027 |
| Registry record updated | March 21, 2024 |
| Trial ID | NCT06322654 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children and young adults aged 0 to 21 diagnosed with SMA, who are undergoing treatment under a drug program.
✕Probably not a fit
Patients with severe cardio-respiratory disorders or advanced osteoporosis may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study compares the effectiveness of two robotically assisted rehabilitation models, Robotically Assisted Verticalization and Robotically Assisted Locomotion, in patients with Spinal Muscular Atrophy (SMA). It is a single-center, randomized, single-blinded study involving 200 participants aged 0 to 21 years. The goal is to identify which rehabilitation model is more beneficial based on the patient's age and baseline functional status. Participants will be randomly assigned to one of the two intervention groups for a comprehensive evaluation.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation outcomes for SMA patients, enhancing their functional abilities.
How similar studies have gone: While there have been studies on robotic rehabilitation, this specific head-to-head comparison of two models in SMA patients is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Cardio-respiratory disorders requiring invasive ventilation * Advanced osteoporosis with multiple fractures prior to treatment * 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
Where it's running
-
Wiktor Dega University Orthopedic and Rehabilitation Hospital
Poznan, Poland Recruiting
Study contacts
- Principal investigator: Marek Jóźwiak — Wiktor Dega University Orthopedic and Rehabilitation Hospital
- Study coordinator: Marek Jóźwiak
- Email: sma@orsk.pl
- Phone: 696052475
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Apitegromab for infants under 2 with spinal muscular atrophy
This trial will test whether adding apitegromab to approved SMA therapy helps infants under 2 with 5q SMA reach better motor milestones.
-
Registry for patients with neuromuscular disorders in Switzerland
This study is creating a database to help people in Switzerland with neuromuscular disorders, like DMD and SMA, get access to new treatments and participate in clinical trials.
-
Registry for patients with Spinal Muscular Atrophy in the UK
This study is collecting information from people with Spinal Muscular Atrophy to better understand their experiences and improve future treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.