Immediate Effects on Gait and Spasticity After the Use of Passive Kinesiotherapy Equipment in the Lower Limbs of Neurological Patients
NCT ID: NCT06696040
Last Updated: 2025-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
80 participants
INTERVENTIONAL
2025-03-01
2028-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pre-intervention and immediate post-intervention
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* individuals with spasiticity (hemiparetic, paraparetic, tetraparetic and hemiparetic children with cerebral palsy)
Exclusion Criteria
* 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
9 Years
ALL
No
Sponsors
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Fernanda Trubian
OTHER
Responsible Party
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Fernanda Trubian
PhD student in Health Sciences
Locations
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Universidade de Caxias do Sul
Caxias Do Suk, Rio Grande do Sul, Brazil
Countries
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Related Links
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Feasibility and safety of early lower limb robot-assisted training in sub-acute stroke patients: a pilot study
Feasibility and outcomes of supplemental gait training by robotic and conventional means in acute stroke rehabilitation
Effects of aerobic cycling training on mobility and functionality of acute stroke subjects: A randomized clinical trial
Enhanced Gait-Related Improvements After Therapist- Versus Robotic-Assisted Locomotor Training in Subjects With Chronic Stroke A Randomized Controlled Study
Other Identifiers
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83118724.0.0000.5341
Identifier Type: -
Identifier Source: org_study_id
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