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

Launched by FERNANDA TRUBIAN · Nov 16, 2024

Keywords

ClinConnect Summary

This study is testing whether a passive leg-mobilization device (the Autofisio500) can produce immediate changes in walking and leg muscle tone for people with spasticity from brain or nerve conditions, such as cerebral palsy or various forms of paralysis. It uses a single-group design (everyone receives the device), with about 80 participants planned, at the Universidade de Caxias do Sul in Brazil. Right after a 30-minute session with the device, researchers will measure how well you walk (gait) and how tight or stiff your leg muscles are, plus a quick balance/mobility test called Timed Up and Go. The main goal is to see whether gait improves right away after using the device.

Who can join: people aged 9 and older with leg spasticity due to conditions like cerebral palsy, hemiparesis, paraparesis, or tetraparesis. You must be able to give informed consent (or have a caregiver sign for you) and not have health issues that could make using the device unsafe (for example serious heart, brain, or joint problems, or certain cognitive difficulties). If eligible, you’ll have an initial assessment of muscle tone, the Timed Up and Go test, and gait measurement, then your leg will be placed in the device for 30 minutes, followed by the same assessments again. The trial is currently enrolling and is planned to run through 2028. Results will be shared when available.

Gender

ALL

Eligibility criteria

• 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