Leg Length Discrepancy Clinical Trial
Official title:
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.
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 28, 2018 |
Est. primary completion date | December 28, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 12 Years |
Eligibility |
Inclusion Criteria: - age 6-12 years - pre-existing leg length difference (LLD) currently being treated by a practitioner with heel raise or orthotics Exclusion Criteria: - history of Osteogenesis Imperfecta (OI) or bone growth dysfunction - history of lower limb deformities, fractures or surgery. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Gosh Ich-Ucl | London |
Lead Sponsor | Collaborator |
---|---|
University College, London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference between treatment groups in LL growth of the treated v untreated leg over the intervention period. | LASER and ultrasound measurements of both legs will be taken monthly during the treatment (months 4-7) phase (unit mm). | 3 months | |
Secondary | Difference in growth of the treated and untreated leg within each subject over the pre-treatment (4 months) and post-treatment (6 months) periods. | LL measurements as for primary outcome - in mm 2. Within-subject differences in growth between treated and untreated legs, compared at pre-treatment and treatment phases. Unit of measurement = mm | 10 months |
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