HemiparesisNCT06696040
Immediate Effects On Gait and Spasticity After The Use Of Passive Kinesiotherapy Equipment In The Lower Limbs Of Neurological Patients
A study testing Passive mobilization using a device in people with Hemiparesis and Paraparesis, run by Fernanda Trubian at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Hemiparesis, Paraparesis, Tetraparesis
- What is being tested?
- Passive mobilization using a device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2025to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- agree and sign the Free and Informed Consent Form or signature of the person responsible
- individuals with spasiticity (hemiparetic, paraparetic, tetraparetic and hemiparetic children with cerebral palsy)
Who cannot join
- over 18 years old whose ability to sign the Free and Informed Consent Form is compromised, or who understand it, but are not responsible for signing the Free and Informed Consent Form
- present cardiovascular, neurological, musculoskeletal instability or other condition(s) that interfere with the use or positioning of the device or gait assessment
- present cognitive deficits that interfere with understanding the ICF and/or understanding how to carry out the protocol
- For the children's group, participants who: 1) are under 8 years of age and/or over 13 years of age will be excluded; 2) no person responsible for signing the TCLE; 3) present cognitive deficits that interfere with understanding the ICF and/or understanding how to carry out the protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Immediate Effects of Mobilization Performed by Passive Kinesiotherapy Equipment on Lower Limbs on Spasticity and Gait in Neurological Patients
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.
- Conditions
- Hemiparesis, Paraparesis, Tetraparesis, Cerebral Palsy, Spastic Gait, Spasticity
- Being tested
- Passive mobilization using a device
- Keywords
- Gait, Spasticity, Passive Kinesiotherapy, Spastic Gait, Passive mobilization device
- Medical subject headings
- Paresis, Paraparesis, Quadriplegia, Cerebral Palsy, Gait Disorders, Neurologic, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive mobilization using a deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention and immediate post-intervention | Experimental | Not described Receives: Device: Passive mobilization using a device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait kinematics
Assessment of gait kinematics using the BAIOBIT pre and post intervention
Measured: Immediate post-evaluation (after using the device for 30 minutes)
Secondary outcomes (2)
Muscle tone - spasticity
Measured: Immediately after using the device for 30 minutes
Timed Up and Go
Measured: Immediately after using the device for 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start1 Mar 2025
- Primary completion31 May 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fernanda Trubian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fernanda Trubian, Universidade de Caxias do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696040
- Sponsor's protocol ID
- 83118724.0.0000.5341
- Status last verified
- Jan 2026
- First submitted
- 16 Nov 2024
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Mobilization Performed by Passive Kinesiotherapy Equipment on Lower Limbs on Spasticity and Gait in Neurological Patients
- ClinicalTrials.gov ID
- NCT06696040
- Acronym / sponsor ID
- 83118724.0.0000.5341
- Conditions
- Hemiparesis, Paraparesis, Tetraparesis, Cerebral Palsy, Spastic Gait, Spasticity
- Keywords
- Gait, Spasticity, Passive Kinesiotherapy, Spastic Gait, Passive mobilization device
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fernanda TrubianUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention and immediate post-intervention | Experimental | Device: Passive mobilization using a device |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- agree and sign the Free and Informed Consent Form or signature of the person responsible
- individuals with spasiticity (hemiparetic, paraparetic, tetraparetic and hemiparetic children with cerebral palsy)
Key exclusion criteria (4 listed)
- over 18 years old whose ability to sign the Free and Informed Consent Form is compromised, or who understand it, but are not responsible for signing the Free and Informed Consent Form
- present cardiovascular, neurological, musculoskeletal instability or other condition(s) that interfere with the use or positioning of the device or gait assessment
- present cognitive deficits that interfere with understanding the ICF and/or understanding how to carry out the protocol
- For the children's group, participants who: 1) are under 8 years of age and/or over 13 years of age will be excluded; 2) no person responsible for signing the TCLE; 3) present cognitive deficits that interfere with understanding the ICF and/or understanding how to carry out the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passive mobilization using a deviceThe 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. | Device | Pre-intervention and immediate post-intervention |
Primary outcome
Gait kinematics
Time frame: Immediate post-evaluation (after using the device for 30 minutes)
Assessment of gait kinematics using the BAIOBIT pre and post intervention
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Feasibility and safety of early lower limb robot-assisted training in sub-acute stroke patients: a pilot studyLink provided by the sponsor.
- Feasibility and outcomes of supplemental gait training by robotic and conventional means in acute stroke rehabilitationLink provided by the sponsor.
- Effects of aerobic cycling training on mobility and functionality of acute stroke subjects: A randomized clinical trialLink provided by the sponsor.
- Enhanced Gait-Related Improvements After Therapist- Versus Robotic-Assisted Locomotor Training in Subjects With Chronic Stroke A Randomized Controlled StudyLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive mobilization using a device in people with Hemiparesis and Paraparesis, run by Fernanda Trubian at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait kinematics (time frame: Immediate post-evaluation (after using the device for 30 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.