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

Not Applicable

• Conditions: Hemiparesis; Paraparesis; Tetraparesis; Cerebral Palsy; Spastic Gait; Spasticity

• Registration Number: NCT06696040
• Lead Sponsor: Fernanda Trubian

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-16
• Study First Submitted QC: 2024-11-16
• Study First Posted: 2024-11-19
• Study Start: 2025-03-01
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28
• Primary Completion: 2028-05-31
• Study Completion: 2028-07-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Gait kinematics	Immediate post-evaluation (after using the device for 30 minutes)	Assessment of gait kinematics using the BAIOBIT pre and post intervention

Secondary Outcome Measures

Name	Time	Method
Muscle tone - spasticity	Immediately after using the device for 30 minutes
Timed Up and Go	Immediately after using the device for 30 minutes

Trial Locations

Locations (1)

Universidade de Caxias do Sul; 🇧🇷 Caxias do Suk, Rio Grande do Sul, Brazil