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Enrolling by Invitation

NCT Number: NCT06696040

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

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Key information

Conditions

Hemiparesis Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Gait Disorders, Neurologic Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Paralysis Paraparesis Paresis Pathological Conditions, Signs and Symptoms Quadriplegia Signs and Symptoms Spastic Gait Spasticity Tetraparesis

Age range

9 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade de Caxias do Sul

Caxias do Sul, Rio Grande do Sul, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Muscle tone - spasticity

    Time frame: Immediately after using the device for 30 minutes

  2. Timed Up and Go

    Time frame: Immediately after using the device for 30 minutes

Sponsors and collaborators

Lead sponsor

Fernanda Trubian

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 19, 2024
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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