An interventional study of Passive mobilization using a device in Hemiparesis, Paraparesis and Tetraparesis, sponsored by Fernanda Trubian. Enrolling by invitation at 1 site in Brazil. Open to participants aged 9 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Fernanda Trubian · Not applicable, Interventional, and Treatment
Undergo assessment of muscle tone (Ashworth Scale), gait (BAIOBIT) and risk of falling (Timed Up and Go) before using the device; Use the device on the spastic lower limb(s) for 30 minutes; Go through the same assessment carried out previously.
7 studies on the registry are indexed under Paraparesis; 3 are open to participants now.
Browse Paraparesis studies →This is the only study on the registry with Fernanda Trubian as lead sponsor.
Compared within Paraparesis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Paresis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Passive mobilization using a device
The protocol consists of three moments: initial assessment, use of the device, and final assessment. In the initial assessment, participants will be positioned supine on a stretcher, where the muscle tone of the lower limb(s) will be tested using the Modified Ashworth Scale. After the physical test with the Modified Ashworth Scale, the TUG test will be carried out, and, finally, gait assessment with the BAIOBIT Inertial Meter with Accelerometer and Gyroscope. At the end of the initial assessment, the Autofisio500 device will be used. To do this, the participant will be positioned again and comfortably supine on the stretcher, and the previously tested lower limb will be attached to the device for movement, between the knee and ankle joints, for 30 minutes, at maximum speed (11 RPM). For the final assessment, the Modified Ashowrth Scale, TUG and gait assessment with the Inertial Meter with Accelerometer and BAIOBIT Gyroscope will be applied again.
Gait kinematics
Assessment of gait kinematics using the BAIOBIT pre and post intervention
Time frame: Immediate post-evaluation (after using the device for 30 minutes)
Muscle tone - spasticity
Time frame: Immediately after using the device for 30 minutes
Timed Up and Go
Time frame: Immediately after using the device for 30 minutes
Plan to share: Yes — Participants in this study will have their identities preserved, information from this research will be treated confidentially and confidentially by the responsible researchers and their direct collaborators. All data will be made anonymous (that is, it will only contain your participation number in the study, but not your name) and only these researchers will be able to handle this database. This ensures the privacy and confidentiality of participant data in any publication of results. The data will be stored in a file, under the custody of the responsible researcher, for 5 (five) years, containing individual files.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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