Cerebral PalsyNEUROREHABNCT06485830
Neural Mobilization and Cerebral Palsy
A study testing Neural mobilization of the lower limb and Conventional physical therapy in people with Cerebral Palsy and Neurologic Disorder, run by University of Seville at 2 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Cerebral Palsy, Neurologic Disorder
- What is being tested?
- Neural mobilization of the lower limb and Conventional physical therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Sep 2024to 15 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Centro de Atencion Infantil Temprana (CAIT), Universidad de Cordoba
Córdoba, Cordoba, 14004
University of Sevilla
Seville, Sevilla, 41009
About this study
Official title: Effect of Neural Mobilization, Compared to Conventional Physical Therapy, in Children Diagnosed With Cerebral Palsy. A Pragmatic Approach
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.
Read more
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
- Being tested
- Neural mobilization of the lower limb, Conventional physical therapy
- Keywords
- range of motion, pain intensity, gross motor function, neural mobilisation, quality of life, muscle stiffness, muscle tension
- Medical subject headings
- Cerebral Palsy, Nervous System Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural mobilization of the lower limbProcedure or surgery
Also called Neurodynamics
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
Conventional physical therapyProcedure or surgery
Also called Usual care
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: Conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to up to 8 weeks, with a 3-month and a 6-month follow up
Secondary outcomes (5)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Baseline to up to 8 weeks, with a 3-month and a 6- month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Sep 2024
- Primary completion3 Dec 2024
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Biomedicina (IBiS) de Sevilla
- Responsible party
- Principal investigator, Alberto Marcos Heredia-Rizo, University of Seville
- Investigators
- Alberto M. Heredia Rizo, PhD, Study director, Instituto de Biomedicina (IBiS) de Sevilla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485830
- Sponsor's protocol ID
- NEUROREHAB
- Acronym
- NEUROREHAB
- Status last verified
- Jul 2024
- First submitted
- 18 Jun 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participation data will be made available in the repository of the University of Seville, Spain
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neural Mobilization, Compared to Conventional Physical Therapy, in Children Diagnosed With Cerebral Palsy. A Pragmatic Approach
- ClinicalTrials.gov ID
- NCT06485830
- Acronym / sponsor ID
- NEUROREHAB / NEUROREHAB
- Conditions
- Cerebral Palsy, Neurologic Disorder
- Keywords
- range of motion, pain intensity, gross motor function, neural mobilisation, quality of life, muscle stiffness, muscle tension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Collaborators
- Instituto de Biomedicina (IBiS) de Sevilla
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 3 Dec 2024 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neural mobilization of the lower limb | Experimental | Procedure: Neural mobilization of the lower limbSeveral 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. |
| Conventional physiotherapy treatment | Active comparator | Procedure: Conventional physical therapyA conventional treatment will be performed, consisting of passive and active mobilizations, active stretching, and techniques aimed at improving daily life activities |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neural mobilization of the lower limbAlso: NeurodynamicsStatic 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 | Procedure or surgery | Neural mobilization of the lower limb |
| Conventional physical therapyAlso: Usual careThe 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 | Procedure or surgery | Conventional physiotherapy treatment |
Primary outcome
Range of motion
Time frame: From baseline to up to 8 weeks, with a 3-month and a 6-month follow up
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.
5 secondary outcomes
Self-reported pain intensity
Time frame: From Baseline to up to 8 weeks, with a 3-month and a 6- month follow up
Spasticity
Time frame: From Baseline to up to 8 weeks, with a 3-month and a 6- month follow up
Activity and Participation
Time frame: From Baseline to up to 8 weeks.,with a 3-month and a 6- month follow up
Health-related quality of life
Time frame: From Baseline to up to 8 weeks, with a 3-month and a 6- month follow up
Myotonometry
Time frame: From Baseline to up to 8 weeks, with a 3-month and a 6- month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Yes. Individual participation data will be made available in the repository of the University of Seville, Spain
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto M. Heredia Rizo, PhD study director
Instituto de Biomedicina (IBiS) de Sevilla
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neural mobilization of the lower limb and Conventional physical therapy in people with Cerebral Palsy and Neurologic Disorder, run by University of Seville at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion (time frame: From baseline to up to 8 weeks, with a 3-month and a 6-month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.