Immediate Effects On Gait and Spasticity After The Use Of Passive Kinesiotherapy Equipment In The Lower Limbs Of Neurological Patients

NCT06696040 — Not applicable, Enrolling by invitation, 80 participants, Fernanda Trubian

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Immediate Effects of Mobilization Performed by Passive Kinesiotherapy Equipment on Lower Limbs on Spasticity and Gait in Neurological Patients

Registry	NCT06696040
Status	Enrolling by invitation
Phase	Not applicable
Study type	Interventional; non randomized, single group, masking: none, treatment
Enrollment	80 (Estimated)
Sponsor	Fernanda Trubian (Other)
Conditions	Hemiparesis, Paraparesis, Tetraparesis, Cerebral Palsy, Spastic Gait, Spasticity
Interventions	Passive mobilization using a device (Device)
Dates	start 2025-03-01, primary completion 2028-05-31 (estimated), completion 2028-07-31 (estimated), first posted 2024-11-19, last updated 2026-05-14
Locations	1 site in Brazil

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Pre-intervention and immediate post-intervention	Experimental	Device: Passive mobilization using a device

Passive mobilization using a device (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.

+Outcome measures

Primary outcomes

Gait kinematics [Immediate post-evaluation (after using the device for 30 minutes)]: Assessment of gait kinematics using the BAIOBIT pre and post intervention

Secondary outcomes

Muscle tone - spasticity [Immediately after using the device for 30 minutes]
Timed Up and Go [Immediately after using the device for 30 minutes]

+Eligibility

Sex: All, ages: 9 Years to any

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

+Locations (1)

Facility	City	Country	Status
Universidade de Caxias do Sul	Caxias do Sul, Rio Grande do Sul	Brazil