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Status unknownNCT03278093Updated Jan 22, 2019

Effect of Orthoses and Underfoot Vibration on Balance in Neuropathy

An observational study in CMT - Charcot-Marie-Tooth Disease, Peripheral Neuropathy and Hereditary Peripheral Neuropathy, sponsored by St George's, University of London. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-22.

Sponsored by St George's, University of London · Observational

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Recruiting — may be out of date.

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Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
15
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 11 studies in Charcot-Marie-Tooth Disease with a site in United Kingdom — 2 open to participants now, 3 under way, 1 of them phase 3. Charcot-Marie-Tooth Disease · United Kingdom.

Started
2017
with 1 other
Observational
8 of 11
2 open now
Registered
9th of 11
by date
Lead sponsor
1 of 11
St George's, University of London

Among the 11 studies in Charcot-Marie-Tooth Disease with a site in United Kingdom, this one is one of 2 that started in 2017, is one of 8 observational ones, and was the 9th registered.

Charcot-Marie-Tooth Disease

113 studies on the registry are indexed under Charcot-Marie-Tooth Disease; 37 are open to participants now.

Browse Charcot-Marie-Tooth Disease studies →

Open to participants now

2 of the 11 studies in Charcot-Marie-Tooth Disease with a site in United Kingdom are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →

Who these studies take

Of the 31 Charcot-Marie-Tooth Disease studies recruiting now, 14 (45%) set no upper age limit and 13 (42%) stop at 75 or younger; 14 take children under 18; 13 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

A cross-sectional study which will look at the effects of AFO's and vibrating insoles on balance performance in people with CMT disease.

Read the detailed description

Balance impairments and falls are more common in people who have Charcot Marie Tooth disease (CMT) than in people without the condition. CMT is a condition which affects the nerves causing a variety of symptoms including sensation impairments and weakness. The impairments are usually most evident in the feet and hands, but they can progress very slowly moving closer to the trunk. Ankle Foot Orthoses (AFO's) are often prescribed to help with walking and daily function. So far the effects of AFO's on standing balance in people who have CMT have not been looked at. Insoles are also often prescribed to realign foot deformity and reduce pain. Insoles which give a vibratory input have had a positive impact on walking in older people but have not been looked at in balance and in CMT. Insoles which give a vibration feedback to the sole of the foot when worn have been designed. This study will look at whether the use of AFO's and the vibratory insoles have an effect on standing balance in people with CMT or related peripheral neuropathy. Balance measurements will be taken in a single session comparing a variety of postures. Patients will be recruited from neurology outpatient clinics at the National Hospital of Neurology and Neurosurgery.

03

Conditions studied

  • CMT - Charcot-Marie-Tooth Disease
  • Peripheral Neuropathy
  • Hereditary Peripheral Neuropathy
  • CMT1A

Keywords

  • Physiotherapy
  • Physical therapy
  • Balance
  • Posturography
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Mobile adults who have CMT with both motor and sensory symptoms.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Clinical or genetically confirmed diagnosis of CMT or related peripheral neuropathy
  2. Mixed sensory and motor presentation
  3. Over 18 years
  4. Able to stand unsupported for five minutes
  5. Able to walk for 50m with or without a walking stick or orthotic devices

Exclusion criteria

Exclusion Criteria:

  1. Presence of other significant neurological disorders (such as multiple sclerosis, cerebrovascular diseases, epilepsy, movement disorders), or major comorbidities (e.g. vestibular dysfunction, use of medication which may affect balance, cognitive impairment, presence of medical conditions in which exercise training may be detrimental).
  2. Presence of peripheral neuropathy caused by a condition other than CMT.
  3. Limb surgery during the six months prior to screening (or planned before final assessment).
  4. Women of child-bearing age if they are pregnant, planning a pregnancy during their time in the study or in the 12 weeks following giving birth. This is due to the effects of pregnancy on balance.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
15 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Posturography

    CODA motion movement analysis for postural sway Measures will be taken in all conditions with feet together and feet apart. Both conditions will also be looked at with eyes open and eyes closed.

    Time frame: 30 second caputer in a variety of conditions

  2. force measures

    AMTI forceplate for centre of pressure . Measures will be taken in all conditions with feet together and feet apart. Both conditions will also be looked at with eyes open and eyes closed.

    Time frame: 30 second caputer in a variety of conditions

07

Study locations

1 of 1 sites recruiting
  • National Hopsital of Neurology and Neurosurgery
    London, WC1N 3BG, United Kingdom
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2017 (actual). Primary completion is estimated for Feb 2019, 16 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 8, 2017
First posted
Sep 11, 2017
StartActual
Oct 20, 2017
Primary completionEst.
Feb 20, 2019
CompletionEst.
Feb 20, 2019
Last update
Jan 22, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03278093
Collaborators
University College London Hospitals
Responsible party
Sponsor
First posted
Sep 11, 2017
Start date
Oct 20, 2017
Primary completion
Feb 20, 2019 (estimated)
Completion
Feb 20, 2019 (estimated)
Last update
Jan 22, 2019

Study contacts

Magdalena Dudziec
Contact
m.dudziec@ucl.ac.uk
020 3108 7520
Gita Ramdharry
Contact
g.ramdharry@ucl.ac.uk
020 3108 7517
Gita Ramdharry
principal investigator · Senior Physiotherapist

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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