Neural Mobilization and Cerebral Palsy (NEUROREHAB)

University of Seville

Status: Enrolling

Conditions: Cerebral Palsy; Neurologic Disorder

Treatments: Procedure: Neural mobilization of the lower limb; Procedure: Conventional physical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06485830

NEUROREHAB

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children and adolescents diagnosed with Cerebral Palsy or presence of spasticity and aged between 5 and 18 years.
• Level I to V 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 6 months prior to the study.
• Undergo a different physical therapy treatment parallel to that developed in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups

Neural mobilization of the lower limb

Experimental group

Description:

Several neural mobilization techniques will be performed for the lower limb, with a special focus on the sciatic nerve. First, three different passive techniques will be used. These will consist of two sets of ten repetitions each with one minute rest between sets. This will last approximately 5 minutes. Then, three dynamic neural mobilization techniques will be performed, with each exercise lasting for 5 minutes per set, including two different sets (one minute rest between them), with a total of 10 minutes of mobilization and one minute of rest per exercise. Therefore the complete approach will last for 30 minutes approximately. Following this set of dynamic neural mobilization exercises, static neural mobilizations of the sciatic nerve will be performed again following the same order and duration than in the beginning.

Treatment:

Procedure: Neural mobilization of the lower limb

Conventional physiotherapy treatment

Active Comparator group

Description:

A conventional treatment will be performed, consisting of passive and active mobilizations, active stretching, and techniques aimed at improving daily life activities

Treatment:

Procedure: Conventional physical therapy