Neural Mobilization and Cerebral Palsy

NCT06485830 | Completed DMC

• 1 other identifier: NEUROREHAB
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Cerebral Palsy; Neurologic Disorder

Keywords

range of motion; pain intensity; gross motor function; neural mobilisation; quality of life; muscle stiffness; muscle tension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Self-reported pain intensity

  From Baseline to up to 8 weeks, with a 3-month and a 6- month follow up

• Spasticity

  From Baseline to up to 8 weeks, with a 3-month and a 6- month follow up

• Activity and Participation

  From Baseline to up to 8 weeks.,with a 3-month and a 6- month follow up

• Health-related quality of life

  From Baseline to up to 8 weeks, with a 3-month and a 6- month follow up

• Myotonometry

  From Baseline to up to 8 weeks, with a 3-month and a 6- month follow up

Study Arms (2)

Neural mobilization of the lower limb

EXPERIMENTAL

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.

Procedure: Neural mobilization of the lower limb

Conventional physiotherapy treatment

ACTIVE COMPARATOR

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

Procedure: Conventional physical therapy

Interventions

Neural mobilization of the lower limb PROCEDURE

Static neural mobilization techniques will be performed for the lower limb. Static procedures will consist of two sets of 10 repetitions, with one minute rest between sets. Next, dynamic neural mobilization techniques will be performed, with each exercise lasting 5 minutes per set, with one minute rest between them. Therefore, dynamic procedures will consist of 10 minutes per mobilization technique (with one minute rest between exercises). At the end of all dynamic mobilization exercises, static mobilizations of the sciatic nerve will be performed again in the same order and with the same duration. The intervention will consist of a total of 8 sessions (either twice a week for four weeks or once a week for a total of 8 weeks). This will depend on the participant usual attendance to his/her treatment center

Also known as: Neurodynamics

Neural mobilization of the lower limb

Conventional physical therapy PROCEDURE

The intervention will include a first part in which active mobilizations, active-assisted mobilizations, and active stretches will be performed, followed by activities aimed at improving physical training, mobility training, and strength training oriented towards specific tasks. After this second part, the first part will be repeated in the same order and duration. The intervention will consist of a total of 8 sessions (either twice a week for four weeks or once a week for a total of 8 weeks). This will depend on the participant usual attendance to his/her treatment center

Also known as: Usual care

Conventional physiotherapy treatment

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Seville: lead
• Instituto de Biomedicina (IBiS) de Sevilla: collaborator

Study Sites (2)

Centro de Atencion Infantil Temprana (CAIT), Universidad de Cordoba

Córdoba, Cordoba, 14004, Spain

Location

University of Sevilla

Seville, Sevilla, 41009, Spain

Location

MeSH Terms

Conditions

Cerebral Palsy; Nervous System Diseases; Pain

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alberto M. Heredia Rizo, PhD

  Instituto de Biomedicina (IBiS) de Sevilla

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Sealed opaque envelopes will be used for treatment allocation. The research in charge of collecting the outcome measures will remained unaware of treatment allocation group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Full Professor

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: July 3, 2024
• Study Start: September 1, 2024
• Primary Completion: December 3, 2024
• Study Completion: May 15, 2025
• Last Updated: May 4, 2026

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, CSR
• Time Frame: Data will become available once the study has been published with no limit for accessibility.

Locations

ES (2)