Immediate Effects On Gait and Spasticity After The Use Of Passive Kinesiotherapy Equipment In The Lower Limbs Of Neurological Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Passive mobilization using a device.
- Who it may be relevant to
- Registry conditions: Hemiparesis, Paraparesis, Tetraparesis, Cerebral Palsy. Basic parameters: from 9 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Immediate Effects of Mobilization Performed by Passive Kinesiotherapy Equipment on Lower Limbs on Spasticity and Gait in Neurological Patients
Overview
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.
Interventions
- 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 assessme
Primary outcome measures
- Gait kinematics [Time frame: Immediate post-evaluation (after using the device for 30 minutes)]
Secondary outcome measures (2)
- 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]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Universidade de Caxias do Sul — Caxias do Sul
Identifiers
NCT: NCT06696040 · 83118724.0.0000.5341