Effect of Orthoses and Underfoot Vibration on Balance in Neuropathy

NCT ID: NCT03278093

Last Updated: 2019-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-20
• Study Completion Date: 2019-02-20

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College London Hospitals

OTHER

Sponsor Role: collaborator

St George's, University of London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gita Ramdharry

Role: PRINCIPAL_INVESTIGATOR

Senior Physiotherapist

Locations

National Hopsital of Neurology and Neurosurgery

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Magdalena Dudziec

Role: CONTACT

m.dudziec@ucl.ac.uk

020 3108 7520

Gita Ramdharry

Role: CONTACT

g.ramdharry@ucl.ac.uk

020 3108 7517

Facility Contacts

Magdalena Dudziec

Role: primary

m.dudziec@ucl.ac.uk

020 3108 7520

Gita Ramdharry

Role: backup

g.ramdharry@ucl.ac.uk

020 3108 7517

Other Identifiers

16.0029

Identifier Type: -

Identifier Source: org_study_id