Neural Mobilization and Cerebral Palsy
NCT Number: NCT06485830
Acronym: NEUROREHAB
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cerebral Palsy|Neurologic Disorder
Interventions: PROCEDURE: Neural mobilization of the lower limb|PROCEDURE: Conventional physical therapy
Sponsor: University of Seville
Collaborators: Instituto de Biomedicina (IBiS) de Sevilla
Sex: ALL
Age: CHILD, ADULT
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-10
Completion Date: 2025-05-15
Locations: University of Sevilla, Sevilla, 41009, Spain

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.

Primary Outcome Measures: Range of motion, Passive range of motion will be assessed for flexion and extension of the hip, knee, and ankle. Using a handheld goniometer, each joint will be measured three times, using the average of the three measures for subsequent analysis., From baseline to up to 8 weeks, with a 3-month and a 6-month follow up
Secondary Outcome Measures: Self-reported pain intensity, Current self-reported pain intensity during the most passive Straight Leg Rise test, as assessed with a 0 to 10 Numeric Pain Rating Scale (NPRS).T he Numeric Pain Rating Scale is a 11-point rating scale that ranges from 0, which denotes no pain at all, to 10, which denotes the maximum bearable pain. This has been selected as the most recommended and valid tool to evaluate self-reported pain intensity., From Baseline to up to 8 weeks, with a 3-month and a 6- month follow up|Spasticity, Spasticity of the hamstrings and adductor muscles will be measured using the modified Tardieu scale. The modified Tardieu Scale is the most common tool used in the clinical setting to evaluate the level of muscle spasticity. The muscle response to a slow and fast stretching will be collected. There are two parts to the assessment that are applied to each muscle group that is examined. In the first part of the assessment, the health professional slowly moves the person's limb to observe the full range of their available movement. In the second part of the assessment, the same limb is moved quickly. Both range of motions (in response to a slow and a fast movement) will be measured using a goniometer. Higher scores represent a lower level of spasticity, From Baseline to up to 8 weeks, with a 3-month and a 6- month follow up|Activity and Participation, The Gross Motor Function Classification System will be used to assess activity dimensions related to standing and walking, while the Functional Mobility Scale will evaluate participation by measuring the time taken to walk 5 and 50 meters. Final scores in the Gross Motor Function Classification System will be categorised in five different levels (I to V), with lover levels denoting higher level of walking independence. For the Functional Mobility Scale, a rating of 1, 2, 3, 4, 5 or 6 is given for each distance, with higher values representing higher levels of independence., From Baseline to up to 8 weeks.,with a 3-month and a 6- month follow up|Health-related quality of life, The Cerebral Palsy Quality of Life Questionnaire will be given to parents or legal tutors of participants (when applicable) or to study participants (depending on their age) to analyze the relationship of the condition with the environment. There are different versions, including a primary caregiver/parent report for children aged 4 to 12 years; and a self-report for children aged 9 to 12 years. Another version has been designed for adolescents aged 13-18 years. Higher scores denote higher levels of well-being., From Baseline to up to 8 weeks, with a 3-month and a 6- month follow up|Myotonometry, Muscle tone and muscle stiffness will be measured using a myotonometer. Assessment points will be marked with a non-invasive demographic pencil on the select points: hamstring muscles, the rectus femoris muscle, and the adductor muscle. Two points will be located in the muscle belly of the abovementioned muscles. At each point, muscle tone and stiffness will be measured using a device called MyotonPRO MyotonPRO (Myoton AS, Estonia). The MyotonPRO is small,non-invasive, and it has shown good validity and high reliability in larger and smaller body muscles.This device delivers a multi-scan mode of three brief mechanical impulses, each one shortly followed by a quick release, to record the damped natural oscillation of the muscle using an accelerometer. Evaluations will be made in both sides., From Baseline to up to 8 weeks, with a 3-month and a 6- month follow up