Efficacy of Whole-Body Vibration Training on Thermal Burn Injury in Paediatrics: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Balance Control:
研究概览
简要总结
60 Patients with partial and full thickness thermal burns of the lower limb and trunk will be indiscriminately assigned to study group Group A(Study group): 30 patients received whole body vibration training on a vibration platform 12-15 minutes, 5 times per week, plus traditional physical therapy exercise program in the form of 60 minutes supervised exercise program for 8 weeks.
Group B (control group):30 patients will receive a traditional physical therapy program. The program consists of 60 minutes of supervised stretching exercise to all involved joints followed by strengthening for affected muscles for 8 weeks.
详细描述
The sample of participants will be chosen from the pediatric burn population by random generator and allocated randomly into two groups by permuted block randomization. Group (A): 30 patients received whole body vibration training on a vibration platform, the frequency, amplitude, and duration utilized in this investigation will be as follows: frequency: 30-40 Hz, 2-4 mm of peak-to-peak vertical plate displacement, and exercise durations ranging from 12-15 minutes. Participants will perform 2 vibration exercises 5 times per week for 8 weeks. The first vibration exercise, a warm-up and familiarization set, will consist of sitting in a chair with both legs on the platform and performing one repetition, which will last 3 minutes. At the completion of the 3-minute warm-up set, participants will perform 3 sets of 3-minute semi-squats on the vibration platform. Vibration exercise time will be increased by 30 seconds each week, with 3 minutes of rest being given between repetitions. The participants will be barefooted and wear similar cotton socks for each vibration session. Maintaining an upright body position, stand on their forefoot with their heels off the ground and the knee joints flexed at an angle of 10u. Their head and eyes were forward and distributed their weight equally on both feet with a foot-to-foot distance of 42 cm. Plus traditional physical therapy exercise programs in 60-minute supervised exercise programs.
Group (B): 30 patients will receive a traditional physical therapy program. The program consists of 60 minutes of supervised stretching exercise to all involved joints followed by strengthening for affected muscles for 8 weeks.
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 (Investigator)
入排标准
- 年龄范围
- 10 Years 至 16 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age will range from 10 to 16 years
- •Patients of both sexes.
- •Participants have 25-40 % partial and full thickness burn of the lower limb and trunk.
- •Participants with complete wound healing or after 35-58 days from the start day of the injury.
排除标准
- •Patients with open burn wounds in any area of the body.
- •Patients diagnosed with acute rheumatoid arthritis
- •Diabetes, neuropathy, and neurological disorders.
- •Severe behavioral cognitive disorders.
- •Previous brain injury or any disease affecting balance, vestibular or visual disorders.
- •Patients with a history of traumatic spine within the past six months.
- •Patients with a prosthesis, Leg amputation, lower limb deformity, recent fracture or bone disease.
研究组 & 干预措施
Group A: Whole Body Vibration Training plus conventional physical therapy exercise program
30 patients received whole body vibration training on a vibration platform for 12-15 minutes, 3 times per week, plus a traditional physical therapy exercise program in the form of a 60-minute supervised exercise program for 8 weeks.
干预措施: Whole Body Vibration Training Plus Conventional Physical Therapy Exercise Program. (Device)
Group A: Whole Body Vibration Training plus conventional physical therapy exercise program
30 patients received whole body vibration training on a vibration platform for 12-15 minutes, 3 times per week, plus a traditional physical therapy exercise program in the form of a 60-minute supervised exercise program for 8 weeks.
干预措施: Conventional Physical Therapy Exercise Program. (Other)
Group B: Conventional Physical Therapy Exercise Program.
30 patients will receive a traditional physical therapy program. The program consists of 60 minutes of supervised exercise stretching exercise to all involved joints followed by strengthening for affected muscles for 8 weeks.
干预措施: Conventional Physical Therapy Exercise Program. (Other)
结局指标
主要结局
Balance Control:
时间窗: 2 momths
Biodex balance scale (Biodex medical systems Inc, Shirley, New York, USA), will be used for balance assessment that include overall stability index that is used to assess fluctuations around the zero point representing standard deviations rather than around a group mean. The overall stability index measures the fluctuations from the horizontal along axes of the Biodex stability system.
次要结局
- Postural Stability(2 months.)
- Muscle Strength(2 months.)
- Functional Mobility(2 months.)
研究者
Hadaya Mosaad
PHD (Principal Investigator)
Cairo University
