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Can we Promote Bone Lengthening With Vibration Therapy?

Primary Purpose

Leg Length Discrepancy, Leg Length Difference

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
LIV 30 Hz
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Leg Length Discrepancy focused on measuring Low intensity vibration, Paediatric bone growth

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Gosh Ich-UclRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

LIV 30 Hz, 0.4 g

LIV 30 Hz, 1.0 g

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
August 23, 2018
Last Updated
September 10, 2018
Sponsor
University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT03666975
Brief Title
Can we Promote Bone Lengthening With Vibration Therapy?
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 28, 2017 (Actual)
Primary Completion Date
December 28, 2018 (Anticipated)
Study Completion Date
December 28, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College, London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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). Subjects at the 4th month will start intervention with LIV and will attend the clinic 3 times per week. Some subjects living further away will use a loaned LIV platform at home for treatment and will be trained in its correct use. They will be asked to send in weekly reports of the number of sessions and minutes per session on the platform. The research team will keep an accurate note of total time. Subjects who have a machine at home will be asked to use the treatment at least 3 times per week, but that they can use it once per day if they wish; they will be asked to record the exact time spent on the platform. All monthly leg-length measurements will take place at the study clinic at a time to suit the family. All subjects will use the following low intensity vibration intervention: 0.4 g and 30 Hz based on the fact that this is the 'low intensity vibration medical device' (LIVMD) machine, developed by Professor Clinton Rubin for use by NASA astronauts that conforms to all IS0 safety measures. The primary outcome measure will be the difference in LL growth of the treated vs. untreated leg over the intervention period. Height and weight of all subjects will be taken monthly and their level of physical activity (0-5) and any high-performance sports activity such as trampoline or plyometrics training (on a scale of 0-5) will be assessed by questionnaire. Previous lower limb dysfunction, injury, fracture or surgery, ongoing illness, drug treatment, growth hormone treatment or use of shoe heel-raise will also be assessed by questionnaire.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leg Length Discrepancy, Leg Length Difference
Keywords
Low intensity vibration, Paediatric bone growth

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Blinding / masking of participants investigator and assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LIV 30 Hz, 0.4 g
Arm Type
Experimental
Arm Description
LIV 30 Hz, 0.4 g Low intensity vibration to short leg 3x / week x 10 wks
Arm Title
LIV 30 Hz, 1.0 g
Arm Type
Experimental
Arm Description
LIV 30 Hz, 1.0 g Low intensity vibration to short leg 3x/week x 10 wks
Intervention Type
Device
Intervention Name(s)
LIV 30 Hz
Other Intervention Name(s)
Low intensity vibration medical device (LivMD) platform
Intervention Description
LivMD LIV platform
Primary Outcome Measure Information:
Title
Difference between treatment groups in LL growth of the treated v untreated leg over the intervention period.
Description
LASER and ultrasound measurements of both legs will be taken monthly during the treatment (months 4-7) phase (unit mm).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Difference in growth of the treated and untreated leg within each subject over the pre-treatment (4 months) and post-treatment (6 months) periods.
Description
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
Time Frame
10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Durtnall, MSc
Phone
+442079378978
Email
michael.durtnall.11@ucl.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Fewtrell
Email
m.fewtrell@ucl.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Fewtrell
Organizational Affiliation
UCL London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gosh Ich-Ucl
City
London
ZIP/Postal Code
WC1N 1EH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Durtnall, PhD
Phone
0044 207 9378978
Email
michael.durtnall.11@ucl.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No

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