CMT - Charcot-Marie-Tooth DiseaseNCT03278093
Effect of Orthoses and Underfoot Vibration on Balance in Neuropathy
An observational study of CMT - Charcot-Marie-Tooth Disease and Peripheral Neuropathy, run by St George's, University of London at 1 site in United Kingdom.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CMT - Charcot-Marie-Tooth Disease, Peripheral Neuropathy, Hereditary Peripheral Neuropathy
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Oct 2017to 20 Feb 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mobile adults who have CMT with both motor and sensory symptoms.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
National Hopsital of Neurology and Neurosurgery
London, WC1N 3BG
Magdalena Dudziec, 020 3108 7520, m.dudziec@ucl.ac.uk
Gita Ramdharry, 020 3108 7517, g.ramdharry@ucl.ac.uk
About this study
Official title: The Feasibility and Effect of Ankle Foot Orthoses and Underfoot Vibration on the Postural Stability of People With Inherited Neuropathy
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.
- Conditions
- CMT - Charcot-Marie-Tooth Disease, Peripheral Neuropathy, Hereditary Peripheral Neuropathy, CMT1A
- Keywords
- Physiotherapy, Physical therapy, Balance, Posturography
- Medical subject headings
- Charcot-Marie-Tooth Disease, Peripheral Nervous System Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 second caputer in a variety of conditions
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.
Measured: 30 second caputer in a variety of conditions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start20 Oct 2017
- Primary completion20 Feb 2019 (estimated)
- Study completion20 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMT - Charcot-Marie-Tooth DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- University College London Hospitals
- Responsible party
- Sponsor
- Investigators
- Gita Ramdharry, Principal investigator, Senior Physiotherapist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278093
- Sponsor's protocol ID
- 16.0029
- Status last verified
- Jan 2019
- First submitted
- 8 Sep 2017
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Effect of Ankle Foot Orthoses and Underfoot Vibration on the Postural Stability of People With Inherited Neuropathy
- ClinicalTrials.gov ID
- NCT03278093
- Acronym / sponsor ID
- 16.0029
- Conditions
- CMT - Charcot-Marie-Tooth Disease, Peripheral Neuropathy, Hereditary Peripheral Neuropathy, CMT1A
- Keywords
- Physiotherapy, Physical therapy, Balance, Posturography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- University College London Hospitals
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 20 Feb 2019 (estimated)
- Study completion
- 20 Feb 2019 (estimated)
- First posted
- 11 Sep 2017 (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.
A cross-sectional study which will look at the effects of AFO's and vibrating insoles on balance performance in people with CMT disease.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mobile adults who have CMT with both motor and sensory symptoms.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Posturography
Time frame: 30 second caputer in a variety of conditions
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.
force measures
Time frame: 30 second caputer in a variety of conditions
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
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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.
Gita Ramdharry principal investigator
Senior Physiotherapist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CMT - Charcot-Marie-Tooth Disease and Peripheral Neuropathy, run by St George's, University of 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 5 inclusion and 4 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 22 Jan 2019. 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 Magdalena Dudziec (020 3108 7520, m.dudziec@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posturography (time frame: 30 second caputer in a variety of conditions). The study lists 2 primary outcomes in all. 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 22 Jan 2019.