Immediate Effects On Gait and Spasticity After The Use Of Passive Kinesiotherapy Equipment In The… (NCT06696040) | Clinical Trial Compass
By InvitationNot Applicable
Immediate Effects On Gait and Spasticity After The Use Of Passive Kinesiotherapy Equipment In The Lower Limbs Of Neurological Patients
Brazil80 participantsStarted 2025-03-01
Plain-language 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.
Who can participate
Age range
9 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial focuses on passive kinesiotherapy equipment for people with conditions like hemiparesis, paraparesis, or spastic gait — given my specific diagnosis, does my pattern of spasticity or movement difficulty match what this study is designed to address?
2Since this trial is listed as 'enrolling by invitation,' can you help me find out who is coordinating it and whether there's any pathway for me to be considered, or is it only open to a specific patient group you're already connected with?
3The study is measuring gait kinematics, which means it's looking at how movement changes right after using this equipment — what does that tell us about whether the benefits, if any, are expected to be long-lasting or just temporary?
4Because this trial is Phase NA — meaning it's not a traditional drug trial with defined safety phases — what do we actually know so far about the risks of using passive kinesiotherapy devices for someone with my level of spasticity or muscle weakness?
5Before considering this study, would it make more sense to first try standard spasticity treatments like physical therapy or medications, and how would participating in this trial fit alongside whatever treatment plan you're already recommending for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Gait kinematics
Timeframe: Immediate post-evaluation (after using the device for 30 minutes)