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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Pedobarographic evaluation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor will be blinded to study groups
入排标准
- 年龄范围
- 3 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between ages of 3 and 18
- •Diagnosed with CP
- •Able to walk at least 10 meters with or without assistive devices
- •GMFCS level 1-3
- •Able to stand independently or with self-support on a vibration platform for 3 minutes
- •Able to understand verbal commands and cooperate during clinical examination
排除标准
- •History of lower extremity botulinum toxin injection or surgery in the past 6 months
- •Any bone fracture in the past 8 weeks
- •Acute thrombosis, muscle-tendon inflammation, nephrolithiasis
- •Presence of implants in the spine or lower extremities
- •Presence of mental impairment, visual or hearing loss affecting balance
- •History of seizures in the past 6 months
- •ASH 4 spasticity/contracture in any lower extremity muscle group
- •Presence of cardiovascular or pulmonary disease
- •Diagnosis of dyskinetic cerebral palsy
研究组 & 干预措施
Group 1: Conventional physical therapy (PT) + WBVTsh (sham)
Group 1 will receive a "sham" WBVT in addition to conventional physical therapy. Over a period of 4 weeks, 3 days per week for 30 minutes each session, participants will engage in conventional physical therapy program.
干预措施: Conventional physical therapy (Other)
Group 1: Conventional physical therapy (PT) + WBVTsh (sham)
Group 1 will receive a "sham" WBVT in addition to conventional physical therapy. Over a period of 4 weeks, 3 days per week for 30 minutes each session, participants will engage in conventional physical therapy program.
干预措施: Sham Whole Body Vibration Training (WBVTsh) (Other)
Group 2: Conventional physical therapy (PT) + WBVTs (shod)
Over a period of 4 weeks, in addition to conventional physical therapy program, the participants will engage in WBVT on commercially available "ThinningPlate" vibration platform, 3 days per week for 15 minutes each session. Group 2 will wear everyday sports shoes during WBVT.
干预措施: Conventional physical therapy (Other)
Group 2: Conventional physical therapy (PT) + WBVTs (shod)
Over a period of 4 weeks, in addition to conventional physical therapy program, the participants will engage in WBVT on commercially available "ThinningPlate" vibration platform, 3 days per week for 15 minutes each session. Group 2 will wear everyday sports shoes during WBVT.
干预措施: Shod Whole Body Vibration Training (WBVTs) (Other)
Group 3: Conventional physical therapy (PT) + WBVTb (barefoot)
Over a period of 4 weeks, in addition to conventional physical therapy program, the participants will engage in WBVT on commercially available "ThinningPlate" vibration platform, 3 days per week for 15 minutes each session. Group 3 will be barefoot during WBVT.
干预措施: Conventional physical therapy (Other)
Group 3: Conventional physical therapy (PT) + WBVTb (barefoot)
Over a period of 4 weeks, in addition to conventional physical therapy program, the participants will engage in WBVT on commercially available "ThinningPlate" vibration platform, 3 days per week for 15 minutes each session. Group 3 will be barefoot during WBVT.
干预措施: Barefoot Whole Body Vibration Training (WBVTb) (Other)
结局指标
主要结局
Pedobarographic evaluation
时间窗: At baseline, at the end of the 4-week treatment (at 4th week), 1 month after the end of treatment (at 8th week)
Static and dynamic plantar pressure parameters will be recorded via pedobarographic evaluation platform. All analysis will be carried out on a flat platform at a constant temperature of 18-22 degrees. All participants will receive clear instructions on test protocols and will be recommended to dress in a way that does not impede lower extremity movements.
Balance
时间窗: At baseline, after the end of the treatment (at 4th week), 1 month after the end of treatment (at 8th week).
Bipedal, unipedal and sitting balance will be evaluated using balance plates.
次要结局
- Bioimpedance analysis(At baseline, after the end of the treatment (at 4th week), 1 month after the end of treatment (at 8th week))
- Modified Ashworth Scale (MAS) for lower extremity muscle tone(At baseline, after the end of the treatment (at 4th week), 1 month after the end of treatment (at 8th week))
- Pediatric Balance Scale (PBS)(At baseline, after the end of the treatment (at 4th week), 1 month after the end of treatment (at 8th week))
- Timed up and go (TUG) test(At baseline, after the end of the treatment (at 4th week), 1 month after the end of treatment (at 8th week))
- Lower extremity muscle strength(At baseline, after the end of the treatment (at 4th week), 1 month after the end of treatment (at 8th week))
- Five times sit-to-stand test (5XSST)(At baseline, after the end of the treatment (at 4th week), 1 month after the end of treatment (at 8th week))
- Gross Motor Function Measure (GMFM-88)(At baseline, after the end of the treatment (at 4th week), 1 month after the end of treatment (at 8th week))
- 6 minutes walk test(At baseline, after the end of the treatment (at 4th week), 1 month after the end of treatment (at 8th week))
- Functional mobility scale (FMS)(At baseline, after the end of the treatment (at 4th week), 1 month after the end of treatment (at 8th week))
- The Gillette Functional Assessment Questionnaire (FAQ)(At baseline, after the end of the treatment (at 4th week), 1 month after the end of treatment (at 8th week))
