Effect of Orthoses and Underfoot Vibration on Balance in Neuropathy

Peripheral Neuropathy Clinical Trial

Official title:

The Feasibility and Effect of Ankle Foot Orthoses and Underfoot Vibration on the Postural Stability of People With Inherited Neuropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03278093
• Other study ID #: 16.0029
• Status: Recruiting
• Start date: October 20, 2017
• Est. completion date: February 20, 2019

Study information

• Verified date: January 2019
• Source: St George's, University of London
• Contact: Magdalena Dudziec
• Phone: 020 3108 7520
• Email: m.dudziec[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: February 20, 2019
• Est. primary completion date: February 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Charcot-Marie-Tooth Disease
• CMT - Charcot-Marie-Tooth Disease
• CMT1A
• Hereditary Peripheral Neuropathy
• Hereditary Sensory and Motor Neuropathy
• Nerve Compression Syndromes
• Peripheral Nervous System Diseases
• Peripheral Neuropathy
• Tooth Diseases

Locations

Country	Name	City	State
United Kingdom	National Hopsital of Neurology and Neurosurgery	London

Sponsors (2)

Lead Sponsor	Collaborator
St George's, University of London	University College London Hospitals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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