Effect of Neural Mobilization, Compared to Conventional Physical Therapy, in Children Diagnosed with Cerebral Palsy. a Pragmatic Approach
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cerebral Palsy
- Sponsor
- University of Seville
- Enrollment
- 42
- Locations
- 2
- Primary Endpoint
- Range of motion
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Alberto Marcos Heredia-Rizo
University Full Professor
University of Seville
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Self-reported pain intensity(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)
- Spasticity(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)
- Health-related quality of life(From Baseline to up to 8 weeks, with a 3-month and a 6- month follow up)