CompletedNot Applicable

Neural Mobilization and Cerebral Palsy

Spain40 participantsStarted 2024-09-01

Plain-language summary

Objective: To assess the effect of neural mobilization applied to the lower limbs, compared to conventional physical therapy, in children diagnosed with Cerebral Palsy. Using the International Classification of Functioning, Disability and Health, the investigators will try to evaluate the impact of the intervention in aspects related with structure, activity, and participation.This project will mainly focus on the structure dimension. More specifically, the investigators aim to observe if a treatment protocol designed to modify the structure (e.g.,the sciatic nerve using neural mobilization techniques), will evoke changes not only in the structural dimension, but also will be able to modify the activity and participation dimensions. Design: A single blinded randomized clinical trial (the evaluator will remain blinded to treatment allocation group) will be conducted. The experimental group will receive an intervention consisting on the use of neurodynamic mobilization procedures of the lower limb and participants in the control group will undergo a conventional physical therapy intervention (stretching, mobilization), without the use of neural mobilization. Subjects: Participants will be aged between 5 and 18 years, and with a confirmed diagnosed of Cerebral Palsy with the presence of spasticity in the lower limbs. Methods: Participants will be randomly allocated into two groups: experimental or control group. The primary outcome will be the range of motion (flexion and extension) of the hip, knee and ankle. Secondary outcomes will include gross motor function, pain intensity, muscle stiffness, muscle tension, and functional measures.

Who can participate

Age range

5 Years – 17 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: * Children and adolescents diagnosed with Cerebral Palsy or presence of spasticity and aged between 5 and 18 years. * Level I to IV in the Gross Motor Function Classification System, which denotes that the participant should be able to walk with or without using assistive devices. * Increased muscle tone in the lower extremities, represented by a score greater than 0 on the Tardieu clinical scale and a positive response in the Duncan Ely test. * Ability to communicate pain. * Ability to follow simple commands. Exclusion Criteria: * Have ankle joint arthrodesis or any surgical operation that prevents joint mobilization of the lower limb to some degree. * Any significant change in medication treatment during the study period that may influence (increase or decrease) muscle tone. * Experience uncontrolled epileptic seizures despite medication. * Have received botulinum toxin treatment in the lower limb within the 3 months prior to the study. * Undergo a different physical therapy treatment parallel to that developed in the study.

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Range of motion

Timeframe: From baseline to up to 8 weeks, with a 3-month and a 6-month follow up

Trial details

NCT IDNCT06485830

SponsorUniversity of Seville

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-03

View on ClinicalTrials.gov More Cerebral Palsy trials