Leg Length DiscrepancyNCT03666975
Can we Promote Bone Lengthening With Vibration Therapy?
A study testing LIV 30 Hz in people with Leg Length Discrepancy and Leg Length Difference, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Leg Length Discrepancy, Leg Length Difference
- What is being tested?
- LIV 30 Hz
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Jan 2017to 28 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age 6-12 years
- pre-existing leg length difference (LLD) currently being treated by a practitioner with heel raise or orthotics
Who cannot join
- history of Osteogenesis Imperfecta (OI) or bone growth dysfunction
- history of lower limb deformities, fractures or surgery.
Trial locations and contacts
1 site in 1 country.
Mary Fewtrell contact
United Kingdom1 site, 1 recruiting
- Recruiting
Gosh Ich-Ucl
London, WC1N 1EH
Michael Durtnall, PhD, 0044 207 9378978, michael.durtnall.11@ucl.ac.uk
About this study
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.
Read the 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.
- Conditions
- Leg Length Discrepancy, Leg Length Difference
- Being tested
- LIV 30 Hz
- Keywords
- Low intensity vibration, Paediatric bone growth
- Medical subject headings
- Leg Length Inequality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIV 30 HzDevice
Also called Low intensity vibration medical device (LivMD) platform
LivMD LIV platform
| Study group | Role | What they receive |
|---|---|---|
| LIV 30 Hz, 0.4 g | Experimental | LIV 30 Hz, 0.4 g Low intensity vibration to short leg 3x / week x 10 wks Receives: 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 Receives: Device: LIV 30 Hz |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
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
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start28 Jan 2017
- Primary completion28 Dec 2018 (estimated)
- Study completion28 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg Length DiscrepancyStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Fewtrell, University College, London
- Investigators
- Mary Fewtrell, Principal investigator, UCL London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666975
- Sponsor's protocol ID
- 210984
- Status last verified
- Sep 2018
- First submitted
- 23 Aug 2018
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03666975
- Acronym / sponsor ID
- 210984
- Conditions
- Leg Length Discrepancy, Leg Length Difference
- Keywords
- Low intensity vibration, Paediatric bone growth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 28 Jan 2017 (actual)
- Primary completion
- 28 Dec 2018 (estimated)
- Study completion
- 28 Dec 2018 (estimated)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| LIV 30 Hz, 0.4 g | Experimental | Device: LIV 30 HzLIV 30 Hz, 0.4 g Low intensity vibration to short leg 3x / week x 10 wks |
| LIV 30 Hz, 1.0 g | Experimental | Device: LIV 30 HzLIV 30 Hz, 1.0 g Low intensity vibration to short leg 3x/week x 10 wks |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- age 6-12 years
- pre-existing leg length difference (LLD) currently being treated by a practitioner with heel raise or orthotics
Key exclusion criteria (2 listed)
- history of Osteogenesis Imperfecta (OI) or bone growth dysfunction
- history of lower limb deformities, fractures or surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIV 30 HzAlso: Low intensity vibration medical device (LivMD) platformLivMD LIV platform | Device | LIV 30 Hz, 0.4 g, LIV 30 Hz, 1.0 g |
Primary outcome
Difference between treatment groups in LL growth of the treated v untreated leg over the intervention period.
Time frame: 3 months
LASER and ultrasound measurements of both legs will be taken monthly during the treatment (months 4-7) phase (unit mm).
1 secondary outcome
Difference in growth of the treated and untreated leg within each subject over the pre-treatment (4 months) and post-treatment (6 months) periods.
Time frame: 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Fewtrell contact
Mary Fewtrell principal investigator
UCL London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIV 30 Hz in people with Leg Length Discrepancy and Leg Length Difference, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Durtnall, MSc (+442079378978, michael.durtnall.11@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between treatment groups in LL growth of the treated v untreated leg over the intervention period. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2018.