Effectiveness of Whole-Body Vibration

Muscle Spasticity Clinical Trial

— WBVibration  

Official title:

Effectiveness of Whole-Body Vibration on Lower Limb Motor Function and Spasticity in Children With Spastic Cerebral Palsy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06330311
• Other study ID #: 20/551-EC
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 29, 2024
• Est. completion date: September 29, 2024

Study information

• Verified date: April 2024
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: September 29, 2024
• Est. primary completion date: September 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity
• Paraparesis, Spastic
• Physical Therapy Modalities
• Spastic Cerebral Palsy
• Vibration; Exposure

Intervention

Other:
• Physiotherapy
Evidence-based multimodal physiotherapy treatment based on learning and motor control

Locations

Country	Name	City	State
Spain	María José Díaz Arribas	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid	Hospital Infantil Universitario Niño Jesús, Madrid, Spain

Country where clinical trial is conducted

Spain, 

References & Publications (76)

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* Note: There are 76 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions)	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.	Baseline
Primary	GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions)	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.	1 month
Primary	GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions)	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.	2 months
Primary	GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions)	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.	6 months
Primary	Modified Ashworth Scale (MAS)	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	Baseline
Primary	Modified Ashworth Scale (MAS)	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	1 month
Primary	Modified Ashworth Scale (MAS)	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	2 month
Primary	Modified Ashworth Scale (MAS)	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	6 month
Secondary	6 Minute Walking Test (6MWT)	6MWT is a test that measures the maximum distance walked by each patient for 6 minutes, on a hard and flat 30 meters surface.; The 6MWT assesses submaximal functional capacity. In addition to distance, the test measures oxygen saturation and heart rate.	Baseline
Secondary	6 Minute Walking Test (6MWT)	6MWT is a test that measures the maximum distance walked by each patient for 6 minutes, on a hard and flat 30 meters surface.; The 6MWT assesses submaximal functional capacity. In addition to distance, the test measures oxygen saturation and heart rate.	1 month
Secondary	6 Minute Walking Test (6MWT)	6MWT is a test that measures the maximum distance walked by each patient for 6 minutes, on a hard and flat 30 meters surface.; The 6MWT assesses submaximal functional capacity. In addition to distance, the test measures oxygen saturation and heart rate.	2 month
Secondary	6 Minute Walking Test (6MWT)	6MWT is a test that measures the maximum distance walked by each patient for 6 minutes, on a hard and flat 30 meters surface.; The 6MWT assesses submaximal functional capacity. In addition to distance, the test measures oxygen saturation and heart rate.	6 month
Secondary	Dynamometry	Hand dynamometer will be used to measure the strength in these muscles of the lower limbs: Ankle dorsal flexion; Ankle plantar flexion; Hip flexors; Hip extensors; Knee flexors; Knee extensors; Hip abductors	Baseline
Secondary	Dynamometry	Hand dynamometer will be used to measure the strength in these muscles of the lower limbs: Ankle dorsal flexion; Ankle plantar flexion; Hip flexors; Hip extensors; Knee flexors; Knee extensors; Hip abductors	1 month
Secondary	Dynamometry	Hand dynamometer will be used to measure the strength in these muscles of the lower limbs: Ankle dorsal flexion; Ankle plantar flexion; Hip flexors; Hip extensors; Knee flexors; Knee extensors; Hip abductors	2 month
Secondary	Dynamometry	Hand dynamometer will be used to measure the strength in these muscles of the lower limbs: Ankle dorsal flexion; Ankle plantar flexion; Hip flexors; Hip extensors; Knee flexors; Knee extensors; Hip abductors	6 month
Secondary	Mini-Balance Evaluation System Test	The Mini-Balance Evaluation System Test is a balance assessment that includes 14 items in 4 categories. The 14 items are scored from 0 to 2.; - Anticipatory; The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome.; - Reactive Postural Control; The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome.; - Sensory Orientation; The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome.; - Dynamic Gait; The minimum value is 0 and the maximum value is 10. Higher scores mean better outcome.; The minimum value overall of the Mini-Balance Evaluation System is 0 and the maximum value overall is 28. Higher scores mean better outcome.	Baseline
Secondary	Mini-Balance Evaluation System Test	The Mini-Balance Evaluation System Test is a balance assessment that includes 14 items in 4 categories. The 14 items are scored from 0 to 2.; - Anticipatory; The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome.; - Reactive Postural Control; The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome.; - Sensory Orientation; The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome.; - Dynamic Gait; The minimum value is 0 and the maximum value is 10. Higher scores mean better outcome.; The minimum value overall of the Mini-Balance Evaluation System is 0 and the maximum value overall is 28. Higher scores mean better outcome.	1 month
Secondary	Mini-Balance Evaluation System Test	The Mini-Balance Evaluation System Test is a balance assessment that includes 14 items in 4 categories. The 14 items are scored from 0 to 2.; - Anticipatory; The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome.; - Reactive Postural Control; The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome.; - Sensory Orientation; The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome.; - Dynamic Gait; The minimum value is 0 and the maximum value is 10. Higher scores mean better outcome.; The minimum value overall of the Mini-Balance Evaluation System is 0 and the maximum value overall is 28. Higher scores mean better outcome.	2 month
Secondary	Mini-Balance Evaluation System Test	The Mini-Balance Evaluation System Test is a balance assessment that includes 14 items in 4 categories. The 14 items are scored from 0 to 2.; - Anticipatory; The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome.; - Reactive Postural Control; The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome.; - Sensory Orientation; The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome.; - Dynamic Gait; The minimum value is 0 and the maximum value is 10. Higher scores mean better outcome.; The minimum value overall of the Mini-Balance Evaluation System is 0 and the maximum value overall is 28. Higher scores mean better outcome.	6 month
Secondary	Cerebral Palsy Quality of Life questionnaire (CP-QOL)	The Cerebral Palsy Quality of Life questionnaire will be used to assess several aspects of subjective happiness and well-being of children with cerebral palsy.; It sets up a profile of qualify of life of children with CP and understand their perception of life.; There are two versions of the CP-QOL: - A primary caregiver-proxy report version.; The minimum value overall of the Cerebral Palsy Quality of Life questionnaire primary caregiver-proxy report version is 53 and the maximum value overall is 477. Higher scores mean better outcome.; - A self-report version for children with CP; The minimum value overall of the Cerebral Palsy Quality of Life questionnaire self-report version for children with CP is 43 and the maximum value overall is 387. Higher scores mean better outcome.	Baseline
Secondary	Cerebral Palsy Quality of Life questionnaire (CP-QOL)	The Cerebral Palsy Quality of Life questionnaire will be used to assess several aspects of subjective happiness and well-being of children with cerebral palsy.; It sets up a profile of qualify of life of children with CP and understand their perception of life.; There are two versions of the CP-QOL: - A primary caregiver-proxy report version.; The minimum value overall of the Cerebral Palsy Quality of Life questionnaire primary caregiver-proxy report version is 53 and the maximum value overall is 477. Higher scores mean better outcome.; - A self-report version for children with CP; The minimum value overall of the Cerebral Palsy Quality of Life questionnaire self-report version for children with CP is 43 and the maximum value overall is 387. Higher scores mean better outcome.	2 month
Secondary	Cerebral Palsy Quality of Life questionnaire (CP-QOL)	The Cerebral Palsy Quality of Life questionnaire will be used to assess several aspects of subjective happiness and well-being of children with cerebral palsy.; It sets up a profile of qualify of life of children with CP and understand their perception of life.; There are two versions of the CP-QOL: - A primary caregiver-proxy report version.; The minimum value overall of the Cerebral Palsy Quality of Life questionnaire primary caregiver-proxy report version is 53 and the maximum value overall is 477. Higher scores mean better outcome.; - A self-report version for children with CP; The minimum value overall of the Cerebral Palsy Quality of Life questionnaire self-report version for children with CP is 43 and the maximum value overall is 387. Higher scores mean better outcome.	6 month