Effect of Orthoses and Underfoot Vibration on Balance in Neuropathy

NCT03278093 | Unknown

• 1 other identifier: 16.0029
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Physiotherapy; Physical therapy; Balance; Posturography

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  30 second caputer in a variety of conditions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St George's, University of London: lead
• University College London Hospitals: collaborator

Study Sites (1)

National Hopsital of Neurology and Neurosurgery

London, WC1N 3BG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Charcot-Marie-Tooth Disease; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Gita Ramdharry

  Senior Physiotherapist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magdalena Dudziec

CONTACT

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

Gita Ramdharry

CONTACT

020 3108 7517; g.ramdharry@ucl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 11, 2017
• Study Start: October 20, 2017
• Primary Completion: February 20, 2019
• Study Completion: February 20, 2019
• Last Updated: January 22, 2019

Record last verified: 2019-01

Locations

GB (1)