Can we Promote Bone Lengthening With Vibration Therapy?

NCT03666975 | Unknown

• 1 other identifier: 210984
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Leg Length Discrepancy; Leg Length Difference

Keywords

Low intensity vibration; Paediatric bone growth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

LIV 30 Hz, 0.4 g

EXPERIMENTAL

LIV 30 Hz, 0.4 g Low intensity vibration to short leg 3x / week x 10 wks

Device: LIV 30 Hz

LIV 30 Hz, 1.0 g

EXPERIMENTAL

LIV 30 Hz, 1.0 g Low intensity vibration to short leg 3x/week x 10 wks

Device: LIV 30 Hz

Interventions

LIV 30 Hz DEVICE

LivMD LIV platform

Also known as: Low intensity vibration medical device (LivMD) platform

LIV 30 Hz, 0.4 g; LIV 30 Hz, 1.0 g

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• age 6-12 years
• pre-existing leg length difference (LLD) currently being treated by a practitioner with heel raise or orthotics

You may not qualify if:

• history of Osteogenesis Imperfecta (OI) or bone growth dysfunction
• history of lower limb deformities, fractures or surgery.

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

Gosh Ich-Ucl

London, WC1N 1EH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Leg Length Inequality

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Mary Fewtrell

  UCL London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Durtnall, MSc

CONTACT

+442079378978; michael.durtnall.11@ucl.ac.uk

Mary Fewtrell

CONTACT

m.fewtrell@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding / masking of participants investigator and assessor
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Paediatric Nutrition

Model Details: Vibration therapy intervention study involving children with pre-existing LLD to be assessed monthly for 4 months and then randomised to have one of 2 vibration therapies for three months and finally 6 months leg-length measurements to assess changes in extra bone length achieved in the shorter leg during the intervention.

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: September 12, 2018
• Study Start: January 28, 2017
• Primary Completion: December 28, 2018
• Study Completion: December 28, 2018
• Last Updated: September 12, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)