Effectiveness of Whole-Body Vibration on Lower Limb Motor Function and Spasticity in Children With Spastic Cerebral Palsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Masking Description
The principal investigator will be blinded to the randomization, patient assessment, and data analysis.
Eligibility Criteria
- Ages
- 8 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Whole-Body Vibration Group
Allocated participants will receive an intervention with Whole-Body vibration (12 - 18 minutes, 12 - 20 hz, 1 - 2 mm progression) added to a physical therapy treatment based on learning and motor control through activities with a defined goal and therapeutic exercises (56 minutes per session) 4 sessions per week for 4 weeks.
Intervention: Physiotherapy (Other)
Control Group
Physical therapy treatment based on learning and motor control through activities with a defined goal and therapeutic exercises (56 minutes per session) 4 sessions per week for 4 weeks.
In the control group, the same measurements will be made at the same time as the subjects in the experimental group.
Intervention: Physiotherapy (Other)
Outcomes
Primary Outcomes
GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions)
Time Frame: 6 months
GROSS MOTOR FUNCTION MEASURE 88 is a clinical test to evaluate changes in gross motor function over time in children and youth with cerebral palsy. The GROSS MOTOR FUNCTION MEASURE 88 is divided in 5 dimensions: A: Lying and rolling. The minimum value is 0 and the maximum value is 51. Higher scores mean better outcome. B: Sitting. The minimum value is 0 and the maximum value is 60. Higher scores mean better outcome. C: Crawling and Kneeling. The minimum value is 0 and the maximum value is 42. Higher scores mean better outcome. D: Standing. The minimum value is 0 and the maximum value is 39. Higher scores mean better outcome. E: Walking, running and jumping. The minimum value is 0 and the maximum value is 72. Higher scores mean better outcome. The minimum value overall of the GROSS MOTOR FUNCTION MEASURE 88 is 0 and the maximum value overall is 264. Higher scores mean better outcome.
Modified Ashworth Scale (MAS)
Time Frame: 6 month
The Modified Ashworth Scale is a clinical tool to measure the increase of muscle tone. MAS is a 6 point numerical scale that graded muscle tone from 0 to 4: 0 = No increase in muscle tone 1 = Slight increase in muscle tone. Minimal resistance at end of range of motion 1+ = Slight increase in muscle tone. Minimal resistance through less than half of range of motion 2 = More marked increase in muscle tone through most range of motion. Affected part easily moved 3 = Considerable increase in muscle tone. Passive movement difficult 4 = Affected part rigid in flexion or extension
GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions)
Time Frame: Baseline
GROSS MOTOR FUNCTION MEASURE 88 is a clinical test to evaluate changes in gross motor function over time in children and youth with cerebral palsy. The GROSS MOTOR FUNCTION MEASURE 88 is divided in 5 dimensions: A: Lying and rolling. The minimum value is 0 and the maximum value is 51. Higher scores mean better outcome. B: Sitting. The minimum value is 0 and the maximum value is 60. Higher scores mean better outcome. C: Crawling and Kneeling. The minimum value is 0 and the maximum value is 42. Higher scores mean better outcome. D: Standing. The minimum value is 0 and the maximum value is 39. Higher scores mean better outcome. E: Walking, running and jumping. The minimum value is 0 and the maximum value is 72. Higher scores mean better outcome. The minimum value overall of the GROSS MOTOR FUNCTION MEASURE 88 is 0 and the maximum value overall is 264. Higher scores mean better outcome.
GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions)
Time Frame: 1 month
GROSS MOTOR FUNCTION MEASURE 88 is a clinical test to evaluate changes in gross motor function over time in children and youth with cerebral palsy. The GROSS MOTOR FUNCTION MEASURE 88 is divided in 5 dimensions: A: Lying and rolling. The minimum value is 0 and the maximum value is 51. Higher scores mean better outcome. B: Sitting. The minimum value is 0 and the maximum value is 60. Higher scores mean better outcome. C: Crawling and Kneeling. The minimum value is 0 and the maximum value is 42. Higher scores mean better outcome. D: Standing. The minimum value is 0 and the maximum value is 39. Higher scores mean better outcome. E: Walking, running and jumping. The minimum value is 0 and the maximum value is 72. Higher scores mean better outcome. The minimum value overall of the GROSS MOTOR FUNCTION MEASURE 88 is 0 and the maximum value overall is 264. Higher scores mean better outcome.
GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions)
Time Frame: 2 months
GROSS MOTOR FUNCTION MEASURE 88 is a clinical test to evaluate changes in gross motor function over time in children and youth with cerebral palsy. The GROSS MOTOR FUNCTION MEASURE 88 is divided in 5 dimensions: A: Lying and rolling. The minimum value is 0 and the maximum value is 51. Higher scores mean better outcome. B: Sitting. The minimum value is 0 and the maximum value is 60. Higher scores mean better outcome. C: Crawling and Kneeling. The minimum value is 0 and the maximum value is 42. Higher scores mean better outcome. D: Standing. The minimum value is 0 and the maximum value is 39. Higher scores mean better outcome. E: Walking, running and jumping. The minimum value is 0 and the maximum value is 72. Higher scores mean better outcome. The minimum value overall of the GROSS MOTOR FUNCTION MEASURE 88 is 0 and the maximum value overall is 264. Higher scores mean better outcome.
Modified Ashworth Scale (MAS)
Time Frame: Baseline
The Modified Ashworth Scale is a clinical tool to measure the increase of muscle tone. MAS is a 6 point numerical scale that graded muscle tone from 0 to 4: 0 = No increase in muscle tone 1 = Slight increase in muscle tone. Minimal resistance at end of range of motion 1+ = Slight increase in muscle tone. Minimal resistance through less than half of range of motion 2 = More marked increase in muscle tone through most range of motion. Affected part easily moved 3 = Considerable increase in muscle tone. Passive movement difficult 4 = Affected part rigid in flexion or extension
Modified Ashworth Scale (MAS)
Time Frame: 1 month
The Modified Ashworth Scale is a clinical tool to measure the increase of muscle tone. MAS is a 6 point numerical scale that graded muscle tone from 0 to 4: 0 = No increase in muscle tone 1 = Slight increase in muscle tone. Minimal resistance at end of range of motion 1+ = Slight increase in muscle tone. Minimal resistance through less than half of range of motion 2 = More marked increase in muscle tone through most range of motion. Affected part easily moved 3 = Considerable increase in muscle tone. Passive movement difficult 4 = Affected part rigid in flexion or extension
Modified Ashworth Scale (MAS)
Time Frame: 2 month
The Modified Ashworth Scale is a clinical tool to measure the increase of muscle tone. MAS is a 6 point numerical scale that graded muscle tone from 0 to 4: 0 = No increase in muscle tone 1 = Slight increase in muscle tone. Minimal resistance at end of range of motion 1+ = Slight increase in muscle tone. Minimal resistance through less than half of range of motion 2 = More marked increase in muscle tone through most range of motion. Affected part easily moved 3 = Considerable increase in muscle tone. Passive movement difficult 4 = Affected part rigid in flexion or extension
Secondary Outcomes
- 6 Minute Walking Test (6MWT)(6 month)
- Mini-Balance Evaluation System Test(6 month)
- Cerebral Palsy Quality of Life questionnaire (CP-QOL)(6 month)
- Dynamometry(6 month)
- 6 Minute Walking Test (6MWT)(Baseline)
- 6 Minute Walking Test (6MWT)(1 month)
- 6 Minute Walking Test (6MWT)(2 month)
- Dynamometry(Baseline)
- Dynamometry(1 month)
- Dynamometry(2 month)
- Mini-Balance Evaluation System Test(Baseline)
- Mini-Balance Evaluation System Test(1 month)
- Mini-Balance Evaluation System Test(2 month)
- Cerebral Palsy Quality of Life questionnaire (CP-QOL)(Baseline)
- Cerebral Palsy Quality of Life questionnaire (CP-QOL)(2 month)
Investigators
MARIA JOSE DIAZ ARRIBAS
Tenured Proffesor
Universidad Complutense de Madrid