Robot-Assisted Rehabilitation for Spinal Muscular Atrophy
A Head-to-head Study Comparing the Functional Value of Two Models of Robotically Assisted Rehabilitation in SMA (Spinal Muscular Atrophy) Patients
Recruiting
N/AInterventional Study
SMA
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
Up to 21
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
200 (estimated)
Sponsor
Wiktor Dega University Orthopedic and Rehabilitation Hospital · Other
Who this trial is looking for
This trial is looking for patients with spinal muscular atrophy (SMA) aged 0 to 21 years. Participants will be taking part in a comparison of two robotic rehabilitation models.
Are You a Good Fit for This Trial?
You may be able to join if
I have signed informed consent to participate.
I have been diagnosed with spinal muscular atrophy.
I am between 0 and 21 years old.
I am receiving treatment for spinal muscular atrophy.
You may not be able to join if
I have cardio-respiratory disorders that require invasive ventilation.
I have advanced osteoporosis with multiple fractures.
I have experienced functional deterioration during rehabilitation.
I cannot cooperate with the therapist.
I have other functional issues that prevent exercise.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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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 fo…
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
Trial Locations
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Eligibility 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…
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
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