Effect of Orthoses and Underfoot Vibration on Balance in Neuropathy

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.

Study Overview

• Status: Unknown
• Conditions: Peripheral Neuropathy; CMT - Charcot-Marie-Tooth Disease; 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
• Enrollment (Anticipated): 15

Contacts and Locations

• Study Contact: Name: Magdalena Dudziec; Phone Number: 020 3108 7520; Email: m.dudziec@ucl.ac.uk
• Study Contact Backup: Name: Gita Ramdharry; Phone Number: 020 3108 7517; Email: g.ramdharry@ucl.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, WC1N 3BG
    • Recruiting
    • National Hopsital of Neurology and Neurosurgery
    • Contact: Magdalena Dudziec; Phone Number: 020 3108 7520; Email: m.dudziec@ucl.ac.uk
    • Contact: Gita Ramdharry; Phone Number: 020 3108 7517; Email: g.ramdharry@ucl.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: St George's, University of London
• Collaborators: University College London Hospitals
• Investigators: Principal Investigator: Gita Ramdharry, Senior Physiotherapist

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2017
• Primary Completion (Anticipated): February 20, 2019
• Study Completion (Anticipated): February 20, 2019

Study Registration Dates

• First Submitted: September 8, 2017
• First Submitted That Met QC Criteria: September 8, 2017
• First Posted (Actual): September 11, 2017

Study Record Updates

• Last Update Posted (Actual): January 22, 2019
• Last Update Submitted That Met QC Criteria: January 18, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Balance; Physical therapy; Physiotherapy; Posturography
• Additional Relevant MeSH Terms: Nervous System Diseases; Congenital Abnormalities; Genetic Diseases, Inborn; Neuromuscular Diseases; Stomatognathic Diseases; Neurodegenerative Diseases; Heredodegenerative Disorders, Nervous System; Nervous System Malformations; Polyneuropathies; Peripheral Nervous System Diseases; Tooth Diseases; Nerve Compression Syndromes; Charcot-Marie-Tooth Disease; Hereditary Sensory and Motor Neuropathy
• Other Study ID Numbers: 16.0029

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No