Neural Mobilization and Cerebral Palsy
- Conditions
- Cerebral PalsyNeurologic Disorder
- Interventions
- Procedure: Neural mobilization of the lower limbProcedure: Conventional physical therapy
- Registration Number
- NCT06485830
- Lead Sponsor
- University of Seville
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 42
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Neural mobilization of the lower limb 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. Conventional physiotherapy treatment Conventional physical therapy A conventional treatment will be performed, consisting of passive and active mobilizations, active stretching, and techniques aimed at improving daily life activities
- Primary Outcome Measures
Name Time Method Range of motion 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.
- Secondary Outcome Measures
Name Time Method Self-reported pain intensity From Baseline to up to 8 weeks, with a 3-month and a 6- month follow up 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.
Activity and Participation From Baseline to up to 8 weeks.,with a 3-month and a 6- month follow up 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.
Spasticity From Baseline to up to 8 weeks, with a 3-month and a 6- month follow up 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
Myotonometry From Baseline to up to 8 weeks, with a 3-month and a 6- month follow up 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.
Health-related quality of life From Baseline to up to 8 weeks, with a 3-month and a 6- month follow up 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.
Trial Locations
- Locations (2)
Centro de Atencion Infantil Temprana (CAIT), Universidad de Cordoba
🇪🇸Cordoba, Spain
University of Sevilla
🇪🇸Sevilla, Spain