Clinical trial NCT06596525: Effects of Barefoot vs. Shod Whole Body Vibration Training in Children With Cerebral Palsy
Official title: Effects of Barefoot vs. Shod Whole Body Vibration Training on Pedobarographic Evaluation, Balance, Endurance and Lower Extremity Functions in Children With Cerebral Palsy: 3-Arm Randomized Controlled Single-Blind Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy (CP)
Keywords: cerebral palsy
whole body vibration
conventional physical therapy
balance
pedobarographic evaluation
gross motor function
spasticity
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be conducted as a single-blind randomized controlled trial with 3 parallel arms, including 2 experimental groups and 1 control group. Participants will be randomized into 3 groups at the beginning of the study.

One arm (Group 1) will be sham comparator and will receive sham WBVT in addition to conventional physical therapy. The other two arms are the experimental groups. Group 2 will receive WBVT with footwear in addition to conventional physical therapy, and Group 3 will receive WBVT with barefoot in addition to conventional physical therapy.

Group 1:Conventional physical therapy (PT) + WBVTsh (sham)

Group 2: PT + WBVTs (shod)

Group 3: PT+ WBVTb (barefoot)
Primary purpose: TREATMENT

Brief summary: Cerebral palsy (CP) refers to a group of lifelong conditions that affect the development of movement and coordination that lead to activity limitations due to damage to the developing fetal or neonatal brain tissue. Although the brain lesion is static, it can lead to progressive musculoskeletal system problems. As a result of the restriction of ankle joint range of motion and many microscopic changes in the muscle structure, plantar pressure distribution is impaired in children with CP which brings about gait and balance problems. Moreover, since physical activity may be restricted due to spasticity, poor motor control, muscle weakness and balance problems; the main goals in CP rehabilitation are normalization of muscle tone, improving walking function by increasing joint range of motion, strength and balance and consequently improving mobility.

There is a need for adjunctive treatment methods with low side effect profiles that can be applied in the long term to prevent musculoskeletal complications and preserve existing functions in children with CP. Whole body vibration training (WBVT), is a therapeutic exercise method that is growing in popularity due to its ease of application, low side effect profile and non-invasiveness as an auxiliary treatment method to traditional rehabilitation programs. Although WBVT is suggested as an easily applicable and safe treatment method with home-type vibration devices; scientific evidence is still lacking and it has not yet been included in routine rehabilitation programs due to the small number of high-quality randomized controlled trials. This study aims to determine the efficacy of barefoot vs. shod WBVT in addition to the conventional physiotherapy, compared to the conventional physiotherapy alone, in children with mild-moderate CP on pedobarographic evaluation, balance, endurance and lower extremity functions. As a result of this study, it might possible to offer children with CP an accessible, safe and helpful treatment method with established protocols.

Detailed description: CP describes a group of neurological disorders that occur after damage to the brain during development. Although brain damage is non-progressive; spasticity, poor motor control, muscle weakness and balance problems are frequently observed due to first motor neuron damage. Restriction of physical activity causes joint contractures and bone deformities, which negatively affect muscle strength and motor function. The main goals in CP treatment are to normalize muscle tone, reduce joint stiffness, increase joint range of motion, strength and balance.

In children with CP, while proximal motor function of the lower extremities is generally preserved; calf muscles, which are well-known to greatly influence postural control, are particularly affected by primary impairments such as spasticity, selective motor control deficits and weakness. As gastrocnemius muscle stiffness increases with growth, it undergoes shortening and atrophy; while its antagonist muscle, the tibialis anterior, often becomes weak. In later ages, ankle joint of motion progressively decreases, accompanied by numerous microscopic changes in muscle structure leading to plantar flexion contractures in children with CP. This results in abnormal plantar pressure distribution, contributing to gait and balance problems. Increased plantar flexor activity or knee flexion increases load on the forefoot. Significant differences have been reported in weight distribution on the feet of children with hemiplegic CP. Previous studies suggest that children with CP exhibit distinct plantar pressure patterns.

WBVT is an emerging therapeutic exercise method in addition to traditional rehabilitation, gaining popularity due to its ease of application and low side effect profile. In WBVT, vibration motion generated by the platform stimulates a movement pattern similar to human gait which results in activation of proprioceptive spinal circuits, leading to compensatory rhythmic muscle contractions in the lower extremities and trunk. Studies conducted on adult, adolescent and pediatric individuals with CP report positive effects of WBVT on gross motor function, balance, muscle strength, muscle tone, spasticity, proprioceptive perception, functional activities and walking. In brief, WBVT stands out as a safe, non-pharmacological method to increase muscle mass in specific pediatric populations.

Enhancing balance and lower extremity function is crucial for improving mobilization, a key goal in CP treatment. CP is commonly approached as a pediatric issue, but approximately 90% of individuals with CP reach adulthood and their life expectancy is similar to that of general population. Given that CP is a lifelong condition, there is a need for adjunctive therapies with low side effect profiles that can be applied in the long term to prevent complications and preserve existing functions. WBVT emerges as a promising adjunctive therapy for inclusion in rehabilitation programs for CP. It is non-invasive, easy to administer and has low side effect profile. WBVT can be applied quickly and conveniently with home-based devices, making it a practical treatment option.

Not only is the number of randomized controlled trials limited, but existing studies also have shortcomings such as a lack of specification regarding footwear (shoes/socks/barefoot/assistive devices) used during WBVT, as well as addressing technical terms (frequency, peak-to-peak displacement, amplitude, etc.), type of vibration (side alternating/synchronous), and the types of exercises (static or dynamic) performed on the platform.

In this study, participants will be selected from children diagnosed with CP who are followed up at the pediatric rehabilitation clinic of Trakya University Department of Physical Medicine and Rehabilitation and who meet the inclusion and exclusion criteria. Participants will be randomized into 3 groups at the beginning of the study. Age, gender, more affected extremity, use of orthoses/assistive devices, Gross Motor Function Classification System (GMFCS) level, history of orthopedic surgery and presence of comorbidities will be recorded for all participants. Written informed consent will be obtained from the families of all participants.

Group 1 will receive sham WBVT in addition to conventional physical therapy program. Groups 2 and 3 will receive WBVT with footwear and barefoot, respectively in addition to conventional physical therapy program. This study aims to determine the efficacy of barefoot vs. shod WBVT in addition to the conventional physiotherapy, compared to the conventional physiotherapy alone, in children with mild-moderate CP on pedobarographic evaluation, balance, endurance and lower extremity functions. By addressing the gaps in the literature and establishing the effects of WBVT, it is anticipated that WBVT will contribute to improving mobility, balance and overall quality of life for children with CP. Detailed protocol presentation in this study will contribute to pediatric rehabilitation in clinical practice and shed light on future research.

Eligibility criteria: Inclusion Criteria:

1. Between ages of 3 and 18
2. Diagnosed with CP
3. Able to walk at least 10 meters with or without assistive devices
4. GMFCS level 1-3
5. Able to stand independently or with self-support on a vibration platform for 3 minutes
6. Able to understand verbal commands and cooperate during clinical examination

Exclusion Criteria:

1. History of lower extremity botulinum toxin injection or surgery in the past 6 months
2. Any bone fracture in the past 8 weeks
3. Acute thrombosis, muscle-tendon inflammation, nephrolithiasis
4. Presence of implants in the spine or lower extremities
5. Pregnancy
6. Presence of mental impairment, visual or hearing loss affecting balance
7. History of seizures in the past 6 months
8. ASH 4 spasticity/contracture in any lower extremity muscle group
9. Presence of cardiovascular or pulmonary disease
10. Diagnosis of dyskinetic cerebral palsy

Primary outcomes:
measure: Pedobarographic evaluation
timeFrame: At baseline, at the end of the 4-week treatment (at 4th week), 1 month after the end of treatment (at 8th week)
measure: Balance
timeFrame: At baseline, after the end of the treatment (at 4th week), 1 month after the end of treatment (at 8th week).
Secondary outcomes:
measure: Bioimpedance analysis
timeFrame: At baseline, after the end of the treatment (at 4th week), 1 month after the end of treatment (at 8th week)
measure: Modified Ashworth Scale (MAS) for lower extremity muscle tone
timeFrame: At baseline, after the end of the treatment (at 4th week), 1 month after the end of treatment (at 8th week)
measure: Pediatric Balance Scale (PBS)
timeFrame: At baseline, after the end of the treatment (at 4th week), 1 month after the end of treatment (at 8th week)
measure: Timed up and go (TUG) test
timeFrame: At baseline, after the end of the treatment (at 4th week), 1 month after the end of treatment (at 8th week)
measure: Lower extremity muscle strength
timeFrame: At baseline, after the end of the treatment (at 4th week), 1 month after the end of treatment (at 8th week)
measure: Five times sit-to-stand test (5XSST)
timeFrame: At baseline, after the end of the treatment (at 4th week), 1 month after the end of treatment (at 8th week)
measure: Gross Motor Function Measure (GMFM-88)
timeFrame: At baseline, after the end of the treatment (at 4th week), 1 month after the end of treatment (at 8th week)
measure: 6 minutes walk test
timeFrame: At baseline, after the end of the treatment (at 4th week), 1 month after the end of treatment (at 8th week)
measure: Functional mobility scale (FMS)
timeFrame: At baseline, after the end of the treatment (at 4th week), 1 month after the end of treatment (at 8th week)
measure: The Gillette Functional Assessment Questionnaire (FAQ)
timeFrame: At baseline, after the end of the treatment (at 4th week), 1 month after the end of treatment (at 8th week)
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University Faculty of Medicine
state: Merkez
Study officials:
affiliation: Trakya University
name: Filiz Tuna, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Trakya University
name: Nur Kakilli, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruck J, Chabot G, Rauch F. Vibration treatment in cerebral palsy: A randomized controlled pilot study. J Musculoskelet Neuronal Interact. 2010 Mar;10(1):77-83.
citation: Leite HR, Camargos ACR, Mendonca VA, Lacerda ACR, Soares BA, Oliveira VC. Current evidence does not support whole body vibration in clinical practice in children and adolescents with disabilities: a systematic review of randomized controlled trial. Braz J Phys Ther. 2019 May-Jun;23(3):196-211. doi: 10.1016/j.bjpt.2018.09.005. Epub 2018 Sep 19.
citation: Sa-Caputo DC, Costa-Cavalcanti R, Carvalho-Lima RP, Arnobio A, Bernardo RM, Ronikeile-Costa P, Kutter C, Giehl PM, Asad NR, Paiva DN, Pereira HV, Unger M, Marin PJ, Bernardo-Filho M. Systematic review of whole body vibration exercises in the treatment of cerebral palsy: Brief report. Dev Neurorehabil. 2016 Oct;19(5):327-33. doi: 10.3109/17518423.2014.994713. Epub 2015 Mar 31.
citation: Young NL. The transition to adulthood for children with cerebral palsy: what do we know about their health care needs? J Pediatr Orthop. 2007 Jun;27(4):476-9. doi: 10.1097/01.bpb.0000271311.87997.e7. No abstract available.
citation: Rauch F, Sievanen H, Boonen S, Cardinale M, Degens H, Felsenberg D, Roth J, Schoenau E, Verschueren S, Rittweger J; International Society of Musculoskeletal and Neuronal Interactions. Reporting whole-body vibration intervention studies: recommendations of the International Society of Musculoskeletal and Neuronal Interactions. J Musculoskelet Neuronal Interact. 2010 Sep;10(3):193-8.
citation: Swolin-Eide D, Magnusson P. Does Whole-Body Vibration Treatment Make Children's Bones Stronger? Curr Osteoporos Rep. 2020 Oct;18(5):471-479. doi: 10.1007/s11914-020-00608-0.
citation: Tekin F, Kavlak E. Short and Long-Term Effects of Whole-Body Vibration on Spasticity and Motor Performance in Children With Hemiparetic Cerebral Palsy. Percept Mot Skills. 2021 Jun;128(3):1107-1129. doi: 10.1177/0031512521991095. Epub 2021 Feb 3.
citation: Martakis K, Stark C, Rehberg M, Semler O, Duran I, Schoenau E. Reference Centiles to Monitor the 6-minute-walk Test in Ambulant Children with Cerebral Palsy and Identification of Effects after Rehabilitation Utilizing Whole-body Vibration. Dev Neurorehabil. 2021 Jan;24(1):45-55. doi: 10.1080/17518423.2020.1770891. Epub 2020 Jun 21.
citation: Wren TA, Lee DC, Hara R, Rethlefsen SA, Kay RM, Dorey FJ, Gilsanz V. Effect of high-frequency, low-magnitude vibration on bone and muscle in children with cerebral palsy. J Pediatr Orthop. 2010 Oct-Nov;30(7):732-8. doi: 10.1097/BPO.0b013e3181efbabc.
citation: Ko MS, Sim YJ, Kim DH, Jeon HS. Effects of Three Weeks of Whole-Body Vibration Training on Joint-Position Sense, Balance, and Gait in Children with Cerebral Palsy: A Randomized Controlled Study. Physiother Can. 2016;68(2):99-105. doi: 10.3138/ptc.2014-77.
citation: Tupimai T, Peungsuwan P, Prasertnoo J, Yamauchi J. Effect of combining passive muscle stretching and whole body vibration on spasticity and physical performance of children and adolescents with cerebral palsy. J Phys Ther Sci. 2016 Jan;28(1):7-13. doi: 10.1589/jpts.28.7. Epub 2016 Jan 30.
citation: El-Shamy SM. Effect of whole-body vibration on muscle strength and balance in diplegic cerebral palsy: a randomized controlled trial. Am J Phys Med Rehabil. 2014 Feb;93(2):114-21. doi: 10.1097/PHM.0b013e3182a541a4.
citation: Ahlborg L, Andersson C, Julin P. Whole-body vibration training compared with resistance training: effect on spasticity, muscle strength and motor performance in adults with cerebral palsy. J Rehabil Med. 2006 Sep;38(5):302-8. doi: 10.1080/16501970600680262.
citation: Unger M, Jelsma J, Stark C. Effect of a trunk-targeted intervention using vibration on posture and gait in children with spastic type cerebral palsy: a randomized control trial. Dev Neurorehabil. 2013;16(2):79-88. doi: 10.3109/17518423.2012.715313.
citation: Saquetto M, Carvalho V, Silva C, Conceicao C, Gomes-Neto M. The effects of whole body vibration on mobility and balance in children with cerebral palsy: a systematic review with meta-analysis. J Musculoskelet Neuronal Interact. 2015 Jun;15(2):137-44.
citation: Matute-Llorente A, Gonzalez-Aguero A, Gomez-Cabello A, Vicente-Rodriguez G, Casajus Mallen JA. Effect of whole-body vibration therapy on health-related physical fitness in children and adolescents with disabilities: a systematic review. J Adolesc Health. 2014 Apr;54(4):385-96. doi: 10.1016/j.jadohealth.2013.11.001. Epub 2014 Jan 1.
citation: Lopez S, Bini F, Del Percio C, Marinozzi F, Celletti C, Suppa A, Ferri R, Staltari E, Camerota F, Babiloni C. Electroencephalographic sensorimotor rhythms are modulated in the acute phase following focal vibration in healthy subjects. Neuroscience. 2017 Jun 3;352:236-248. doi: 10.1016/j.neuroscience.2017.03.015. Epub 2017 Mar 18.
citation: Cheng HY, Yu YC, Wong AM, Tsai YS, Ju YY. Effects of an eight-week whole body vibration on lower extremity muscle tone and function in children with cerebral palsy. Res Dev Disabil. 2015 Mar;38:256-61. doi: 10.1016/j.ridd.2014.12.017. Epub 2015 Jan 7.
citation: Schirinzi T, Romano A, Favetta M, Sancesario A, Burattini R, Summa S, Della Bella G, Castelli E, Bertini E, Petrarca M, Vasco G. Non-invasive Focal Mechanical Vibrations Delivered by Wearable Devices: An Open-Label Pilot Study in Childhood Ataxia. Front Neurol. 2018 Oct 9;9:849. doi: 10.3389/fneur.2018.00849. eCollection 2018.
citation: Murillo N, Valls-Sole J, Vidal J, Opisso E, Medina J, Kumru H. Focal vibration in neurorehabilitation. Eur J Phys Rehabil Med. 2014 Apr;50(2):231-42.
citation: Cochrane DJ. Vibration exercise: the potential benefits. Int J Sports Med. 2011 Feb;32(2):75-99. doi: 10.1055/s-0030-1268010. Epub 2010 Dec 16.
citation: Galli M, Cimolin V, Pau M, Leban B, Brunner R, Albertini G. Foot pressure distribution in children with cerebral palsy while standing. Res Dev Disabil. 2015 Jun-Jul;41-42:52-7. doi: 10.1016/j.ridd.2015.05.006. Epub 2015 Jun 6.
citation: Nsenga Leunkeu A, Lelard T, Shephard RJ, Doutrellot PL, Ahmaidi S. Gait cycle and plantar pressure distribution in children with cerebral palsy: clinically useful outcome measures for a management and rehabilitation. NeuroRehabilitation. 2014;35(4):657-63. doi: 10.3233/NRE-141163.
citation: Femery V, Moretto P, Renaut H, Thevenon A, Lensel G. Measurement of plantar pressure distribution in hemiplegic children: changes to adaptative gait patterns in accordance with deficiency. Clin Biomech (Bristol). 2002 Jun;17(5):406-13. doi: 10.1016/s0021-9290(02)00063-5.
citation: Wiley ME, Damiano DL. Lower-extremity strength profiles in spastic cerebral palsy. Dev Med Child Neurol. 1998 Feb;40(2):100-7. doi: 10.1111/j.1469-8749.1998.tb15369.x.