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Effect of Orthoses and Underfoot Vibration on Balance in Neuropathy

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ClinicalTrials.gov Identifier: NCT03278093
Recruitment Status : Recruiting
First Posted : September 11, 2017
Last Update Posted : March 21, 2018
Sponsor:
Collaborator:
University College London Hospitals
Information provided by (Responsible Party):
St George's, University of London

Brief 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.

Condition or disease
CMT - Charcot-Marie-Tooth Disease Peripheral Neuropathy Hereditary Peripheral Neuropathy CMT1A

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 Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Feasibility and Effect of Ankle Foot Orthoses and Underfoot Vibration on the Postural Stability of People With Inherited Neuropathy
Actual Study Start Date : October 20, 2017
Estimated Primary Completion Date : July 20, 2018
Estimated Study Completion Date : July 20, 2018





Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Mobile adults who have CMT with both motor and sensory symptoms.
Criteria

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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278093


Contacts
Contact: Magdalena Dudziec 020 3108 7520 m.dudziec@ucl.ac.uk
Contact: Gita Ramdharry 020 3108 7517 g.ramdharry@ucl.ac.uk

Locations
United Kingdom
National Hopsital of Neurology and Neurosurgery Recruiting
London, United Kingdom, WC1N 3BG
Contact: Magdalena Dudziec    020 3108 7520    m.dudziec@ucl.ac.uk   
Contact: Gita Ramdharry    020 3108 7517    g.ramdharry@ucl.ac.uk   
Sponsors and Collaborators
St George's, University of London
University College London Hospitals
Investigators
Principal Investigator: Gita Ramdharry Senior Physiotherapist

Responsible Party: St George's, University of London
ClinicalTrials.gov Identifier: NCT03278093     History of Changes
Other Study ID Numbers: 16.0029
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St George's, University of London:
Physiotherapy
Physical therapy
Balance
Posturography

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Tooth Diseases
Charcot-Marie-Tooth Disease
Nerve Compression Syndromes
Hereditary Sensory and Motor Neuropathy
Neuromuscular Diseases
Nervous System Diseases
Stomatognathic Diseases
Nervous System Malformations
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Polyneuropathies
Congenital Abnormalities
Genetic Diseases, Inborn