Spastic Cerebral PalsyWBVibrationNCT06330311
Effectiveness of Whole-Body Vibration
A study testing Physiotherapy in people with Spastic Cerebral Palsy and Physical Therapy Modalities, run by Universidad Complutense de Madrid at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Spastic Cerebral Palsy, Physical Therapy Modalities, Vibration; Exposure
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 29 Mar 2024to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Whole-Body Vibration on Lower Limb Motor Function and Spasticity in Children With Spastic Cerebral Palsy
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.
Read the 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.
- Conditions
- Spastic Cerebral Palsy, Physical Therapy Modalities, Vibration; Exposure, Lower Extremity Weakness, Spastic, Muscle Spasticity
- Being tested
- Physiotherapy
- Keywords
- Spastic Cerebral Palsy, Physical Therapy, Whole-Body Vibration, Gross Motor Function, Lower Limb Spasticity
- Medical subject headings
- Cerebral Palsy, Paraparesis, Spastic, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
Also called Therapeutic exercise
Evidence-based multimodal physiotherapy treatment based on learning and motor control
| Study group | Role | What they receive |
|---|---|---|
| Whole-Body Vibration Group | Experimental | 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. Receives: Other: Physiotherapy |
| Control Group | Active comparator | 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. Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: 1 month
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.
Measured: 2 months
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.
Measured: 6 months
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
Measured: Baseline
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
Measured: 1 month
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
Measured: 2 month
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
Measured: 6 month
Secondary outcomes (15)
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.
Measured: Baseline
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.
Measured: 1 month
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.
Measured: 2 month
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.
Measured: 6 month
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
Measured: Baseline
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
Measured: 1 month
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
Measured: 2 month
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
Measured: 6 month
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.
Measured: Baseline
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.
Measured: 1 month
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.
Measured: 2 month
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.
Measured: 6 month
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.
Measured: Baseline
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.
Measured: 2 month
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.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start29 Mar 2024
- Primary completion29 Oct 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (76)Papers the sponsor has linked to this study.
- Other trials for Spastic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants will be randomly allocated to experimental or control group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Infantil Universitario Niño Jesús, Madrid, Spain
- Responsible party
- Principal investigator, MARIA JOSE DIAZ ARRIBAS, Universidad Complutense de Madrid
- Investigators
- María J Díaz Arribas, PhD, Study director, Universidad Complutense de MadridÁngela C Álvarez Melcón, PhD, Study director, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330311
- Sponsor's protocol ID
- 20/551-EC
- Acronym
- WBVibration
- Status last verified
- Apr 2025
- First submitted
- 19 Mar 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McIntyre S, Goldsmith S, Webb A, Ehlinger V, Hollung SJ, McConnell K, Arnaud C, Smithers-Sheedy H, Oskoui M, Khandaker G, Himmelmann K; Global CP Prevalence Group*. Global prevalence of cerebral palsy: A systematic analysis. Dev Med Child Neurol. 2022 Dec;64(12):1494-1506. doi: 10.1111/dmcn.15346. Epub 2022 Aug 11.
PubMed 35952356Sadowska M, Sarecka-Hujar B, Kopyta I. Cerebral Palsy: Current Opinions on Definition, Epidemiology, Risk Factors, Classification and Treatment Options. Neuropsychiatr Dis Treat. 2020 Jun 12;16:1505-1518. doi: 10.2147/NDT.S235165. eCollection 2020.
PubMed 32606703Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
PubMed 17370477Pandyan AD, Gregoric M, Barnes MP, Wood D, Van Wijck F, Burridge J, Hermens H, Johnson GR. Spasticity: clinical perceptions, neurological realities and meaningful measurement. Disabil Rehabil. 2005 Jan 7-21;27(1-2):2-6. doi: 10.1080/09638280400014576. No abstract available.
PubMed 15799140Novak I, McIntyre S, Morgan C, Campbell L, Dark L, Morton N, Stumbles E, Wilson SA, Goldsmith S. A systematic review of interventions for children with cerebral palsy: state of the evidence. Dev Med Child Neurol. 2013 Oct;55(10):885-910. doi: 10.1111/dmcn.12246. Epub 2013 Aug 21.
PubMed 23962350Kahraman A, Seyhan K, Deger U, Kutluturk S, Mutlu A. Should botulinum toxin A injections be repeated in children with cerebral palsy? A systematic review. Dev Med Child Neurol. 2016 Sep;58(9):910-7. doi: 10.1111/dmcn.13135. Epub 2016 Apr 22.
PubMed 27103334Multani I, Manji J, Hastings-Ison T, Khot A, Graham K. Botulinum Toxin in the Management of Children with Cerebral Palsy. Paediatr Drugs. 2019 Aug;21(4):261-281. doi: 10.1007/s40272-019-00344-8.
PubMed 31257556Buizer AI, Martens BHM, Grandbois van Ravenhorst C, Schoonmade LJ, Becher JG, Vermeulen RJ. Effect of continuous intrathecal baclofen therapy in children: a systematic review. Dev Med Child Neurol. 2019 Feb;61(2):128-134. doi: 10.1111/dmcn.14005. Epub 2018 Sep 6.
PubMed 30187921Hasnat MJ, Rice JE. Intrathecal baclofen for treating spasticity in children with cerebral palsy. Cochrane Database Syst Rev. 2015 Nov 13;2015(11):CD004552. doi: 10.1002/14651858.CD004552.pub2.
PubMed 26563961Health Quality Ontario. Lumbosacral Dorsal Rhizotomy for Spastic Cerebral Palsy: A Health Technology Assessment. Ont Health Technol Assess Ser. 2017 Jul 6;17(10):1-186. eCollection 2017.
PubMed 28757906Hagglund G, Alriksson-Schmidt A, Lauge-Pedersen H, Rodby-Bousquet E, Wagner P, Westbom L. Prevention of dislocation of the hip in children with cerebral palsy: 20-year results of a population-based prevention programme. Bone Joint J. 2014 Nov;96-B(11):1546-52. doi: 10.1302/0301-620X.96B11.34385.
PubMed 25371472Novak I, Hines M, Goldsmith S, Barclay R. Clinical prognostic messages from a systematic review on cerebral palsy. Pediatrics. 2012 Nov;130(5):e1285-312. doi: 10.1542/peds.2012-0924. Epub 2012 Oct 8.
PubMed 23045562Amirmudin NA, Lavelle G, Theologis T, Thompson N, Ryan JM. Multilevel Surgery for Children With Cerebral Palsy: A Meta-analysis. Pediatrics. 2019 Apr;143(4):e20183390. doi: 10.1542/peds.2018-3390.
PubMed 30918016Lamberts RP, Burger M, du Toit J, Langerak NG. A Systematic Review of the Effects of Single-Event Multilevel Surgery on Gait Parameters in Children with Spastic Cerebral Palsy. PLoS One. 2016 Oct 18;11(10):e0164686. doi: 10.1371/journal.pone.0164686. eCollection 2016.
PubMed 27755599Tekin F, Kavlak E, Cavlak U, Altug F. Effectiveness of Neuro-Developmental Treatment (Bobath Concept) on postural control and balance in Cerebral Palsied children. J Back Musculoskelet Rehabil. 2018;31(2):397-403. doi: 10.3233/BMR-170813.
PubMed 29171980
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Whole-Body Vibration on Lower Limb Motor Function and Spasticity in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06330311
- Acronym / sponsor ID
- WBVibration / 20/551-EC
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Hospital Infantil Universitario Niño Jesús, Madrid, Spain
- Study start
- 29 Mar 2024 (actual)
- Primary completion
- 29 Oct 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The participants will be randomly allocated to experimental or control group
| Arm | Type | Receives |
|---|---|---|
| Whole-Body Vibration Group | Experimental | Other: PhysiotherapyAllocated 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. |
| Control Group | Active comparator | Other: PhysiotherapyPhysical 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. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhysiotherapyAlso: Therapeutic exerciseEvidence-based multimodal physiotherapy treatment based on learning and motor control | Other | Control Group, Whole-Body Vibration Group |
Primary outcome
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.
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: 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
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
15 secondary outcomes
6 Minute Walking Test (6MWT)
Time frame: Baseline
6 Minute Walking Test (6MWT)
Time frame: 1 month
6 Minute Walking Test (6MWT)
Time frame: 2 month
6 Minute Walking Test (6MWT)
Time frame: 6 month
Dynamometry
Time frame: Baseline
Dynamometry
Time frame: 1 month
Dynamometry
Time frame: 2 month
Dynamometry
Time frame: 6 month
Mini-Balance Evaluation System Test
Time frame: Baseline
Mini-Balance Evaluation System Test
Time frame: 1 month
Mini-Balance Evaluation System Test
Time frame: 2 month
Mini-Balance Evaluation System Test
Time frame: 6 month
Cerebral Palsy Quality of Life questionnaire (CP-QOL)
Time frame: Baseline
Cerebral Palsy Quality of Life questionnaire (CP-QOL)
Time frame: 2 month
Cerebral Palsy Quality of Life questionnaire (CP-QOL)
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Background: PubMed 35952356McIntyre S, Goldsmith S, Webb A, Ehlinger V, Hollung SJ, McConnell K, Arnaud C, Smithers-Sheedy H, Oskoui M, Khandaker G, Himmelmann K; Global CP Prevalence Group*. Global prevalence of cerebral palsy: A systematic analysis. Dev Med Child Neurol. 2022 Dec;64(12):1494-1506. doi: 10.1111/dmcn.15346. Epub 2022 Aug 11.
- Background: PubMed 32606703Sadowska M, Sarecka-Hujar B, Kopyta I. Cerebral Palsy: Current Opinions on Definition, Epidemiology, Risk Factors, Classification and Treatment Options. Neuropsychiatr Dis Treat. 2020 Jun 12;16:1505-1518. doi: 10.2147/NDT.S235165. eCollection 2020.
- Background: PubMed 17370477Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
- Background: PubMed 15799140Pandyan AD, Gregoric M, Barnes MP, Wood D, Van Wijck F, Burridge J, Hermens H, Johnson GR. Spasticity: clinical perceptions, neurological realities and meaningful measurement. Disabil Rehabil. 2005 Jan 7-21;27(1-2):2-6. doi: 10.1080/09638280400014576. No abstract available.
- Background: PubMed 23962350Novak I, McIntyre S, Morgan C, Campbell L, Dark L, Morton N, Stumbles E, Wilson SA, Goldsmith S. A systematic review of interventions for children with cerebral palsy: state of the evidence. Dev Med Child Neurol. 2013 Oct;55(10):885-910. doi: 10.1111/dmcn.12246. Epub 2013 Aug 21.
- Background: PubMed 27103334Kahraman A, Seyhan K, Deger U, Kutluturk S, Mutlu A. Should botulinum toxin A injections be repeated in children with cerebral palsy? A systematic review. Dev Med Child Neurol. 2016 Sep;58(9):910-7. doi: 10.1111/dmcn.13135. Epub 2016 Apr 22.
- Background: PubMed 31257556Multani I, Manji J, Hastings-Ison T, Khot A, Graham K. Botulinum Toxin in the Management of Children with Cerebral Palsy. Paediatr Drugs. 2019 Aug;21(4):261-281. doi: 10.1007/s40272-019-00344-8.
- Background: PubMed 30187921Buizer AI, Martens BHM, Grandbois van Ravenhorst C, Schoonmade LJ, Becher JG, Vermeulen RJ. Effect of continuous intrathecal baclofen therapy in children: a systematic review. Dev Med Child Neurol. 2019 Feb;61(2):128-134. doi: 10.1111/dmcn.14005. Epub 2018 Sep 6.
- Background: PubMed 26563961Hasnat MJ, Rice JE. Intrathecal baclofen for treating spasticity in children with cerebral palsy. Cochrane Database Syst Rev. 2015 Nov 13;2015(11):CD004552. doi: 10.1002/14651858.CD004552.pub2.
- Background: PubMed 28757906Health Quality Ontario. Lumbosacral Dorsal Rhizotomy for Spastic Cerebral Palsy: A Health Technology Assessment. Ont Health Technol Assess Ser. 2017 Jul 6;17(10):1-186. eCollection 2017.
- Background: PubMed 25371472Hagglund G, Alriksson-Schmidt A, Lauge-Pedersen H, Rodby-Bousquet E, Wagner P, Westbom L. Prevention of dislocation of the hip in children with cerebral palsy: 20-year results of a population-based prevention programme. Bone Joint J. 2014 Nov;96-B(11):1546-52. doi: 10.1302/0301-620X.96B11.34385.
- Background: PubMed 23045562Novak I, Hines M, Goldsmith S, Barclay R. Clinical prognostic messages from a systematic review on cerebral palsy. Pediatrics. 2012 Nov;130(5):e1285-312. doi: 10.1542/peds.2012-0924. Epub 2012 Oct 8.
- Individual participant dataSharing planned: No
Related trials for Spastic Cerebral Palsy
Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Not yet recruiting
Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
Cerebral Palsy (CP)
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María J Díaz Arribas, PhD study director
Universidad Complutense de Madrid
Ángela C Álvarez Melcón, PhD study director
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Spastic Cerebral Palsy and Physical Therapy Modalities, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions) (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06330311, which also lists 76 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.