Clinical trial NCT06485830: Neural Mobilization and Cerebral Palsy
Official title: Effect of Neural Mobilization, Compared to Conventional Physical Therapy, in Children Diagnosed with Cerebral Palsy. a Pragmatic Approach
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Neurologic Disorder
Keywords: range of motion
pain intensity
gross motor function
neural mobilisation
quality of life
muscle stiffness
muscle tension
Lead sponsor: University of Seville
Sponsor class: OTHER
Collaborators: name: Instituto de Biomedicina (IBiS) de Sevilla
First posted: 2024-07-03
Enrollment: 42
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Range of motion
timeFrame: From baseline to up to 8 weeks, with a 3-month and a 6-month follow up
Secondary outcomes:
measure: Self-reported pain intensity
timeFrame: From Baseline to up to 8 weeks, with a 3-month and a 6- month follow up
measure: Spasticity
timeFrame: From Baseline to up to 8 weeks, with a 3-month and a 6- month follow up
measure: Activity and Participation
timeFrame: From Baseline to up to 8 weeks.,with a 3-month and a 6- month follow up
measure: Health-related quality of life
timeFrame: From Baseline to up to 8 weeks, with a 3-month and a 6- month follow up
measure: Myotonometry
timeFrame: From Baseline to up to 8 weeks, with a 3-month and a 6- month follow up
Other outcomes:
Locations:
city: Cordoba
country: Spain
facility: Centro de Atencion Infantil Temprana (CAIT), Universidad de Cordoba
city: Sevilla
country: Spain
facility: University of Sevilla
Study officials:
affiliation: Instituto de Biomedicina (IBiS) de Sevilla
name: Alberto M. Heredia Rizo, PhD
role: STUDY_DIRECTOR
References: