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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06330311
Other study ID # 20/551-EC
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.


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Study Design


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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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
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