Clinical trial NCT06330311: Effectiveness of Whole-Body Vibration
Official title: Effectiveness of Whole-Body Vibration on Lower Limb Motor Function and Spasticity in Children With Spastic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spastic Cerebral Palsy
Physical Therapy Modalities
Vibration; Exposure
Lower Extremity Weakness, Spastic
Muscle Spasticity
Keywords: Spastic Cerebral Palsy
Physical Therapy
Whole-Body Vibration
Gross Motor Function
Lower Limb Spasticity
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Hospital Infantil Universitario Niño Jesús, Madrid, Spain
First posted: 2024-03-26
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants will be randomly allocated to experimental or control group
Primary purpose: TREATMENT

Brief summary: Cerebral Palsy is the most common cause of severe physical disability in childhood and may present difficulties and limitations that will have an impact on their independence and integration in all social areas.

Within interventions aiming to manage CP Whole-Body Vibration (WBV) has shown some benefits such as reducing spasticity or improving strength and functionality of the lower limbs.

The aim of this study is to assess the effectiveness on motor function and spasticity of the lower limbs by adding an intervention with WBV to an evidence-based multimodal physiotherapy treatment in children with CP.

Detailed description: Cerebral Palsy is the most common cause of severe physical disability in childhood (1.5 - 3 cases per thousand live births) and may or may not be accompanied by intellectual, sensory, communication deficits and epileptic syndromes depending on the brain region affected. The most frequent form of presentation is spastic cerebral palsy, characterized by atypical motor development, abnormal movement or posture, hyperreflexia, and increased muscle tone. These difficulties and limitations will have an impact on their independence and integration in all social areas.

The use of Whole-Body Vibration (WBV) to reduce spasticity of the lower limb and thereby improve functionality has been used for more than a decade showing some benefits such as reducing spasticity or improving strength and functionality of the lower limbs.

The purpose of this randomized controlled trial is to assess the effectiveness on motor function and spasticity of the lower limbs by adding an intervention with WBV to an evidence-based multimodal physiotherapy treatment in children with CP.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with spastic cerebral palsy.
* Aged between 8 and 14 years.
* GMFCS I, II or III: with the ability to walk independently with or without technical aids; with the ability to stand for 3 minutes independently or gripped on the stand; with the ability to understand and follow simple instructions; with the ability to tolerate clinical tests and examinations.

Exclusion Criteria:

* Participation in treatments with serial casting or botulinum toxin during the 3 months prior to the study.
* Recent orthopedic surgery (less than 12 months).
* Participation in other muscle strengthening programs during the 4 months prior to this clinical study.
* Children who have developed fixed contractures in lower limbs joints.
* Medical conditions where physical exercise is contraindicated.

Primary outcomes:
measure: GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions)
timeFrame: Baseline
measure: GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions)
timeFrame: 1 month
measure: GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions)
timeFrame: 2 months
measure: GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions)
timeFrame: 6 months
measure: Modified Ashworth Scale (MAS)
timeFrame: Baseline
measure: Modified Ashworth Scale (MAS)
timeFrame: 1 month
measure: Modified Ashworth Scale (MAS)
timeFrame: 2 month
measure: Modified Ashworth Scale (MAS)
timeFrame: 6 month
Secondary outcomes:
measure: 6 Minute Walking Test (6MWT)
timeFrame: Baseline
measure: 6 Minute Walking Test (6MWT)
timeFrame: 1 month
measure: 6 Minute Walking Test (6MWT)
timeFrame: 2 month
measure: 6 Minute Walking Test (6MWT)
timeFrame: 6 month
measure: Dynamometry
timeFrame: Baseline
measure: Dynamometry
timeFrame: 1 month
measure: Dynamometry
timeFrame: 2 month
measure: Dynamometry
timeFrame: 6 month
measure: Mini-Balance Evaluation System Test
timeFrame: Baseline
measure: Mini-Balance Evaluation System Test
timeFrame: 1 month
measure: Mini-Balance Evaluation System Test
timeFrame: 2 month
measure: Mini-Balance Evaluation System Test
timeFrame: 6 month
measure: Cerebral Palsy Quality of Life questionnaire (CP-QOL)
timeFrame: Baseline
measure: Cerebral Palsy Quality of Life questionnaire (CP-QOL)
timeFrame: 2 month
measure: Cerebral Palsy Quality of Life questionnaire (CP-QOL)
timeFrame: 6 month
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: María José Díaz Arribas
Study officials:
affiliation: Universidad Complutense de Madrid
name: María J Díaz Arribas, PhD
role: STUDY_DIRECTOR
affiliation: Universidad Complutense de Madrid
name: Ángela C Álvarez Melcón, PhD
role: STUDY_DIRECTOR
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