Effect of Whole Body Vibration Therapy on Muscle Function, Gross Motor Function and Bone Mineral Density in Children With Spinal Muscular Atrophy - a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Body Height
研究概览
简要总结
Spinal muscular atrophy (SMA) are one of the common physical disabilities in childhood. For SMA, progressive muscle weakness and early fatigue hamper the mobility of the sufferers. Osteopenia is common for this population group due to poor bone growth and muscle disuse. As a result, non-traumatic related fractures and bone pain are common. Recently, whole body vibration therapy (WBVT) has been proven to improve bone health and muscle function in healthy adults and post-menopausal women. Among the limited studies on the WBVT for children with muscular dystrophies, promising results have been shown on gross motor function, balance, and muscle strength and the WBVT appears to be safe for children with SMA.
The present pilot study is designed to investigate if WBVT is safe and feasible for individuals with SMA and if WBVT can improve muscle function, functional abilities, postural control and bone mineral density in children with SMA. Convenience samples of 10 individuals with SMA type III will be recruited. The participants will receive the WBVT of 25 Hertz and a peak-to-peak amplitude of 4mm for a session of about 18 minutes, 3 days per week for 4 weeks. Assessment will be performed at the baseline and the completion of the intervention to examine the muscle function, functional abilities, postural control and bone mineral density of the participants.
It is anticipated that the outcomes of this pilot study for SMA may show if this intervention is safe, feasible and beneficial for children with SMA type III regarding to muscle function, functional abilities, postural control and bone mineral content and if there may be any related practical issues of this intervention to this population group. The outcomes also provide research evidence to clinicians if this intervention should be recommended to individuals of similar problems.
详细描述
Spinal muscular atrophy (SMA) is an X-chromosome-linked disorder, in which there is a loss of motor neurons from the anterior horn of the spinal cord due to a deletion of the SMN1 gene. SMA is usually classified under 4 categories, based on the onset time and severity of the conditions. Type I SMA is the most severe category, when the boy is diagnosed before 6 months old and has severe muscle weakness, causing them to have poor head control and unable to sit independently. Boys with type II SMA are diagnosed between 6 to 18 months of age and able to sit independently but cannot stand or walk without any assistance. SMA type III is diagnosed between 18 months to 30 years of age and the boys can stand and walk independently but still with variable degrees of muscle weakness. Some would lose ambulation in their early adulthood and require wheelchair mobility. Type IV SMA is the mildest form with an adult onset, normal mobility and longevity. However, they also experience mild muscle weakness throughout their life. This muscle weakness would lead to early loss of ambulation, reduced pulmonary function and complications due to immobilisation such as osteoporosis. Early fatality is not uncommon.
Osteopenia due to disuse is, in fact, common in children with physical disabilities. In a study of 69 children with moderate to severe cerebral palsy (CP), it was shown that the distal femur and lumbar spine areal bone mineral density (BMD) z-scores appeared to worsen with time, which may reflect the possibility of poor bone growth velocity in individuals with CP. Fracture and bone pain are the major complications of osteopenia in CP and the majority of non-traumatic fractures occur in the femur and humerus. Other factors that may contribute to osteopenia in physical disabilities include pubertal delay, vitamin D deficiency, dietary calcium deficiency, under-nutrition and low body weight, corticosteroids or anticonvulsants. Despite of minimising these factors, osteopenia appears to persist.
Limited studies have been done to examine the bone health in children with SMA but more in children with Duchene muscular dystrophy (DMD), which have similar clinical presentations although with different pathologies. A study on 41 boys with DMD, bone density in the proximal femur was significantly decreased even in the ambulatory boys (mean z-score -1.6) and progressing rapidly to a level of 4 standard deviations below the norm when compared with normal boys. Forty-four percent of the boys had an episode of fracture, mostly in the lower limbs.
Recently whole body vibration therapy (WBVT) has been preliminarily shown as a simple and effective technique to increase bone mass, muscle mass and strength. In general, the user stands in a static position such as standing or performs some dynamic movements on a device providing vibrations from a few Hz to 50 Hz (Hertz, Hz represents the number of complete up and down movement cycle per second). It has been hypothesised that the vibrations stimulate the muscle spindles and alpha-motor neurons, eliciting a muscle contraction. The latter would increase the muscle mass and in turn, increase the bone mass. It has also been postulated that direct effect by mechanical deformation of bones and increased fluid flow in the canalicular spaces and stimulation of the osteocytes may contribute increase in bone mass with the vibration therapy. Increase in oxygen consumption, body temperature and skin blood flow (erythema) have also been demonstrated. As WBVT does not elicit a significant cardiovascular response, it appears to be safe to be used in children with various medical conditions.
In a systematic review on 22 studies (including 7 studies on CP and 2 on DMD) for the effect of WBVT on body composition and physical fitness in children and adolescents with disabilities, the authors concluded that WBVT appeared to improve bone mass and muscle strength in this population group. However, heterogeneity of the studies was noticed, including great variations in the treatment protocols and lacking of a control group and hence, no recommended minimal dosage of WBVT can be concluded. Since this review, two more randomised controlled trials (RCT) were published on children with CP. In one recent study, 30 children with spastic diplegia CP of GMFCS levels I to II were randomised into a treatment group (WBVT with traditional physiotherapy) and a control group (physiotherapy only). The treatment group received 3 lots of 3 minutes on and 3 minutes off vibration (12 to 18 Hz), 2 to 5 times per week for 3 months. Significant improvement in knee extensor strength and standing stability was reported in the treatment group. In another study in 2013, 27 children with spastic diplegia or hemiplegia CP of GMFCS levels I to III were randomised to a treatment group or control group and then crossed over after 4 weeks. The treatment group performed specific trunk exercise on the vibration platform (35 Hz), 5 to 10 minute per session, 2 to 4 sessions per week for 4 weeks. Significant improvement was found in gait speed, muscle thickness of the abdominal muscle and number of sit-ups done 1 minute. A visual improvement was also shown in sitting and standing postures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type III spinal muscular atrophy
- •Be able to stand on the vibration platform with or without support
- •Be able to undertake clinical examination and DXA evaluation
- •Informed consent by the participant's parent/ guardian
排除标准
- •There is a history of fracture within 8 weeks of enrolment of the present study and acute thrombosis, muscle or tendon inflammation, renal stones, discopathy or arthritis as reported by their parent/ guardian.
- •There is a history of using any of the following medications, regardless of dose, for at least 1 month, within 3 months of enrolment into the present study: anabolic agents, or growth hormone.
结局指标
主要结局
Body Height
时间窗: 4 weeks
measure height in cm
North Star Ambulatory Assessment
时间窗: 4 weeks
examine the gross motor function of the participants. A summed score will be added from each test item.
Muscle Strength of Right Knee Extensors
时间窗: 4 weeks
measure muscle strength of knee extensors in sitting using dynamometer in terms of Newton
Pediatric Evaluation of Disability Inventory
时间窗: 4 weeks
assess functional capacities in the domains of self care, mobility and social function with a summary score in each domain. A dichotomous score will be given to each question in each domain: 0= unable and 1= able. In self care domain, there are 73 questions, i.e. maximal score is 73. In mobility domain, there are 59 questions i.e. maximal score is 59. In social function domain, there are 65 questions i.e. maximal score is 65.
Body Weight
时间窗: 4 weeks
measure weight in kilograms
Body Mass Index
时间窗: 4 weeks
calculated based on body height and weight in terms of kg/m2
Volumetric Bone Mineral Density of Lumbar Spine
时间窗: 4 weeks
Volumetric bone mineral density of lumbar spine (L2 to L4) in grams/cm3
Range of Right Hip Extension
时间窗: 4 weeks
measure hip extension in prone using goniometer in degrees
Range of Left Knee Flexion
时间窗: 4 weeks
measure knee flexion in prone using goniometer in degrees
Range of Right Knee Extension
时间窗: 4 weeks
measure knee extension in sitting using goniometer in degrees
Range of Right Ankle Dorsiflexion
时间窗: 4 weeks
measure ankle dorsiflexion in sitting using goniometer in degrees
Muscle Strength of Right Hip Flexors
时间窗: 4 weeks
measure muscle strength of hip flexors in supine using dynamometer in terms of Newton
Bone Mineral Content of Whole Body (Excluding Head)
时间窗: 4 weeks
Whole body (excluding head) BMC will be measured in grams
Areal Bone Mineral Density of Femur
时间窗: 4 weeks
Areal bone mineral density of femur will be measured in grams/cm2
Areal Bone Mineral Density of Total Body (Excluding Head)
时间窗: 4 weeks
Areal bone mineral density of total body (excluding head) will be measured in grams/cm2
Range of Left Ankle Plantarflexion
时间窗: 4 weeks
measure ankle plantarflexion in sitting using goniometer in degrees
Muscle Strength of Right Hip Extensors
时间窗: 4 weeks
measure muscle strength of hip extensors in prone using dynamometer in terms of Newton
2-minute Walk Test
时间窗: 4 weeks
assess submaximal exercise capacity by measuring the distance covered in the 2 minutes in metres
Bone Mineral Content of Femur
时间窗: 4 weeks
Distal femur BMC will be measured in grams
Range of Left Hip Flexion
时间窗: 4 weeks
measure hip flexion in supine using goniometer in degrees
Muscle Strength of Left Knee Flexors
时间窗: 4 weeks
measure muscle strength of knee flexors in sitting using dynamometer in terms of Newton
Muscle Strength of Left Knee Extensors
时间窗: 4 weeks
measure muscle strength of knee extensors in sitting using dynamometer in terms of Newton
Muscle Strength of Right Ankle Dorsiflexors
时间窗: 4 weeks
measure muscle strength of ankle dorsiflexors in sitting using dynamometer in terms of Newton
Muscle Strength of Left Ankle Dorsiflexors
时间窗: 4 weeks
measure muscle strength of ankle dorsiflexors in sitting using dynamometer in terms of Newton
Segmental Assessment of Trunk Control_active
时间窗: 4 weeks
assess the segmental trunk control in sitting position with an ordinal score will be given in active trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.
Segmental Assessment of Trunk Control-static
时间窗: 4 weeks
assess the segmental trunk control in sitting position with an ordinal score will be given in static trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.
Range of Left Hip Extension
时间窗: 4 weeks
measure hip extension in prone using goniometer in degrees
Range of Right Hip Abduction
时间窗: 4 weeks
measure hip abduction in supine using goniometer in degrees
Range of Left Hip Abduction
时间窗: 4 weeks
measure hip abduction in supine using goniometer in degrees
Muscle Strength of Left Hip Flexors
时间窗: 4 weeks
measure muscle strength of hip flexors in supine using dynamometer in terms of Newton
Muscle Strength of Right Hip Abductors
时间窗: 4 weeks
measure muscle strength of hip abductors in supine using dynamometer in terms of Newton
Muscle Strength of Left Ankle Plantarflexors
时间窗: 4 weeks
measure muscle strength of ankle plantarflexors in sitting using dynamometer in terms of Newton
Segmental Assessment of Trunk Control-reactive
时间窗: 4 weeks
assess the segmental trunk control in sitting position with an ordinal score will be given in reactive trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.
Range of Right Hip Flexion
时间窗: 4 weeks
measure hip flexion in supine using goniometer in degrees
Range of Right Knee Flexion
时间窗: 4 weeks
measure knee flexion in prone using goniometer in degrees
Range of Left Knee Extension
时间窗: 4 weeks
measure knee extension in sitting using goniometer in degrees
Range of Left Ankle Dorsiflexion
时间窗: 4 weeks
measure ankle dorsiflexion in sitting using goniometer in degrees
Range of Right Ankle Plantarflexion
时间窗: 4 weeks
measure ankle plantarflexion in sitting using goniometer in degrees
Muscle Strength of Left Hip Extensors
时间窗: 4 weeks
measure muscle strength of hip extensors in prone using dynamometer in terms of Newton
Muscle Strength of Right Knee Flexors
时间窗: 4 weeks
measure muscle strength of knee flexors in sitting using dynamometer in terms of Newton
Muscle Strength of Left Hip Abductors
时间窗: 4 weeks
measure muscle strength of hip abductors in supine using dynamometer in terms of Newton
Muscle Strength of Right Ankle Plantarflexors
时间窗: 4 weeks
measure muscle strength of ankle plantarflexors in sitting using dynamometer in terms of Newton
次要结局
- Percentage of Attendance of Participants(4 weeks)
- Visual Analogue Scale(4 weeks)
研究者
Dr Tamis Wai-mun PIN
Assistant Professor
The Hong Kong Polytechnic University