UnknownNot Applicable

Effect of Orthoses and Underfoot Vibration on Balance in Neuropathy

United Kingdom15 participantsStarted 2017-10-20

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

. 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).
. Presence of peripheral neuropathy caused by a condition other than CMT.
. Limb surgery during the six months prior to screening (or planned before final assessment).
. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Posturography

Timeframe: 30 second caputer in a variety of conditions

force measures

Timeframe: 30 second caputer in a variety of conditions

Trial details

NCT IDNCT03278093

SponsorSt George's, University of London

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-02-20

Contact for this trial

Magdalena Dudziec

020 3108 7520 m.dudziec@ucl.ac.uk

View on ClinicalTrials.gov More CMT - Charcot-Marie-Tooth Disease trials