Investigating Vibration Therapy on Rate of Growth in Length of Shorter Leg of Children 6-12 Years With Leg-length Discrepancy (LLD): a Pilot Randomised Trial of Different Low Intensity Vibration (LIV) Therapy.
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Difference between treatment groups in LL growth of the treated v untreated leg over the intervention period.
研究概览
简要总结
This research will assess whether vibration therapy can increase bone-growth in length of the shorter leg in children aged 6-12 years with pre-existing leg length difference (LLD) which is being treated with a heel-raise or orthotics. Children will be referred by orthopaedic and musculoskeletal clinics, physiotherapists and orthotists. Children will have monthly measurement of leg length (LL) over a 13 month period (4 months pre-treatment, 3 months treatment, 6 months post-treatment) using a portable Ultrasound-laser system which is safe, accurate, reproducible and validated against standing x-ray measurement. During the treatment phase they will be randomised to receive vibration therapy 3 times per week using a vibration platform at 30 Hz and very low amplitude of 0.4g (less than experienced when walking) or 30 Hz at 1.0 g (the same force as standing with the effect of gravity). The child will stand with the shorter leg on the platform and the longer leg on a stationary block for 15 minutes per treatment session. The aim is to assess the potential of this safe, non-invasive and potentially cost-effective method for levelling LL. If effective, the research could be extended in future to children with much larger LLD in whom it could potentially avoid the need for surgery and minimise long-term musculoskeletal disability.
详细描述
Subjects with a documented treatment history for LLD will be recruited via orthopaedic, orthotic, physiotherapy and musculoskeletal clinical practitioners in London.
All specialist practitioners and clinics across London will be informed about the study (via Practitioner/LLD Letter), asking them to forward information direct to eligible subjects .
20-25 subjects with pre-existing LLD who are undergoing treatment with shoe raises, heel-lifts or built-up shoes will be recruited. Parents receiving the Parental information sheet outlining the study are therein invited to contact the researchers who will arrange a baseline visit to the clinic. At this visit, the study will be discussed and all questions answered. If the child and family are willing to take part, written informed consent will be taken from the parent and assent from the child. Baseline measurements will be taken as below.
Treatment of subjects:
All subjects will have accurate LL measurement at baseline and then LL measurement monthly over 13 months (4 months pre-treatment, 3 months intervention and 6 months follow-up).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Blinding / masking of participants investigator and assessor
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 6-12 years
- •pre-existing leg length difference (LLD) currently being treated by a practitioner with heel raise or orthotics
排除标准
- •history of Osteogenesis Imperfecta (OI) or bone growth dysfunction
- •history of lower limb deformities, fractures or surgery.
结局指标
主要结局
Difference between treatment groups in LL growth of the treated v untreated leg over the intervention period.
时间窗: 3 months
LASER and ultrasound measurements of both legs will be taken monthly during the treatment (months 4-7) phase (unit mm).
次要结局
- Difference in growth of the treated and untreated leg within each subject over the pre-treatment (4 months) and post-treatment (6 months) periods.(10 months)
研究者
Mary Fewtrell
Professor of Paediatric Nutrition
University College, London