Comparing two robotic rehabilitation methods for SMA 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
This study is testing which of two robotic rehabilitation methods helps young people with Spinal Muscular Atrophy feel and move better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | N/A to 21 Years |
| Sex | All |
| Sponsor | Wiktor Dega University Orthopedic and Rehabilitation Hospital Academic / other |
| Locations | 1 site (Poznan) |
| Trial ID | NCT06322654 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children and young adults aged 0 to 21 diagnosed with SMA, who are undergoing treatment under a drug program.
Not a fit: Patients with severe cardio-respiratory disorders or advanced osteoporosis may not benefit from this study.
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 performed: While there have been studies on robotic rehabilitation, this specific head-to-head comparison of two models in SMA patients is relatively novel.
Eligibility criteria
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 this trial is running
Poznan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.