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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cerebral Palsy; Hemiparesis; Paraparesis; Spasticity; Tetraparesis; Spastic Gait
• Intervention / Treatment: Device: Passive mobilization using a device

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Caxias do Sul, Rio Grande do Sul, Brazil
      • Universidade de Caxias do Sul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pre-intervention and immediate post-intervention

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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait kinematics	Assessment of gait kinematics using the BAIOBIT pre and post intervention	Immediate post-evaluation (after using the device for 30 minutes)

Secondary Outcome Measures

Outcome Measure	Time Frame
Muscle tone - spasticity	Immediately after using the device for 30 minutes
Timed Up and Go	Immediately after using the device for 30 minutes

Collaborators and Investigators

• Sponsor: Fernanda Trubian

Publications and helpful links

Helpful Links

• 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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: November 16, 2024
• First Submitted That Met QC Criteria: November 16, 2024
• First Posted (Actual): November 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Gait; Spasticity; Passive Kinesiotherapy; Spastic Gait; Passive mobilization device
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Brain Damage, Chronic; Paralysis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscle Spasticity; Cerebral Palsy; Paresis; Gait Disorders, Neurologic; Paraparesis; Quadriplegia
• Other Study ID Numbers: 83118724.0.0000.5341

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Participants in this study will have their identities preserved, information from this research will be treated confidentially and confidentially by the responsible researchers and their direct collaborators. All data will be made anonymous (that is, it will only contain your participation number in the study, but not your name) and only these researchers will be able to handle this database. This ensures the privacy and confidentiality of participant data in any publication of results.

The data will be stored in a file, under the custody of the responsible researcher, for 5 (five) years, containing individual files.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No