Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06596525
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
Effects of Barefoot vs Shod Whole Body Vibration Training in Children With Cerebral Palsy
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 shoessocksbarefootassistive devices used during WBVT as well as addressing technical terms frequency peak-to-peak displacement amplitude etc type of vibration side alternatingsynchronous 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 orthosesassistive 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
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 shoessocksbarefootassistive devices used during WBVT as well as addressing technical terms frequency peak-to-peak displacement amplitude etc type of vibration side alternatingsynchronous 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 orthosesassistive 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None