Skip to content

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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06696040
Enrollment
80
Registered
2024-11-19
Start date
2025-03-01
Completion date
2028-07-31
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy, Hemiparesis, Paraparesis, Spastic Gait, Spasticity, Tetraparesis

Keywords

Gait, Spasticity, Passive Kinesiotherapy, Spastic Gait, Passive mobilization device

Brief 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.

Interventions

DEVICEPassive 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.

Sponsors

Fernanda Trubian
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Gait kinematicsImmediate post-evaluation (after using the device for 30 minutes)Assessment of gait kinematics using the BAIOBIT pre and post intervention

Secondary

MeasureTime frame
Muscle tone - spasticityImmediately after using the device for 30 minutes
Timed Up and GoImmediately after using the device for 30 minutes

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026