Immediate Effects on Gait and Spasticity After the Use of Passive Kinesiotherapy Equipment in the Lower Limbs of Neurological Patients

NCT06696040 | Enrolling By Invitation

• 1 other identifier: 83118724.0.0000.5341
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Gait; Spasticity; Passive Kinesiotherapy; Spastic Gait; Passive mobilization device

Outcome Measures

Primary Outcomes (1)

• Gait kinematics

  Assessment of gait kinematics using the BAIOBIT pre and post intervention

  Immediate post-evaluation (after using the device for 30 minutes)

Secondary Outcomes (2)

• Muscle tone - spasticity

  Immediately after using the device for 30 minutes

• Timed Up and Go

  Immediately after using the device for 30 minutes

Study Arms (1)

Pre-intervention and immediate post-intervention

EXPERIMENTAL

Device: Passive mobilization using a device

Interventions

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.

Pre-intervention and immediate post-intervention

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fernanda Trubian: lead

Study Sites (1)

Universidade de Caxias do Sul

Caxias Do Suk, Rio Grande do Sul, Brazil

Location

Related 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

MeSH Terms

Conditions

Paresis; Paraparesis; Quadriplegia; Cerebral Palsy; Gait Disorders, Neurologic; Muscle Spasticity

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD student in Health Sciences

Study Record Dates

• First Submitted: November 16, 2024
• First Posted: November 19, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: March 28, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

BR (1)