Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
42 participants
INTERVENTIONAL
2024-07-10
2025-06-15
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Neural mobilization of the lower limb
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.
Neural mobilization of the lower limb
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 physiotherapy treatment
A conventional treatment will be performed, consisting of passive and active mobilizations, active stretching, and techniques aimed at improving daily life activities
Conventional physical therapy
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
Interventions
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Neural mobilization of the lower limb
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 therapy
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
5 Years
18 Years
ALL
No
Sponsors
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Instituto de Biomedicina (IBiS) de Sevilla
UNKNOWN
University of Seville
OTHER
Responsible Party
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Alberto Marcos Heredia-Rizo
University Full Professor
Principal Investigators
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Alberto M. Heredia Rizo, PhD
Role: STUDY_DIRECTOR
Instituto de Biomedicina (IBiS) de Sevilla
Locations
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Centro de Atencion Infantil Temprana (CAIT), Universidad de Cordoba
Córdoba, Cordoba, Spain
University of Sevilla
Seville, Sevilla, Spain
Countries
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Central Contacts
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Facility Contacts
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Ramon Gonzalez Matilla, MSc
Role: primary
Ramon Gonzalez-Matilla, MSc
Role: backup
Alberto M Heredia-Rizo, PhD
Role: primary
Alberto M. Heredia-Rizo, PhD
Role: backup
Other Identifiers
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NEUROREHAB
Identifier Type: -
Identifier Source: org_study_id