Clinical Trials

The effects of prolonged wear of textured shoe insoles on walking in people with MS

Type of Study/Intervention

Allied Health

Recruitment Status

Closed

Form of MS

All types of MS

Brief summary

Many people with Multiple Sclerosis (MS) experience problems with walking, which can make day to day activities difficult and often leads to falls. Improving walking ability is, therefore, of primary importance in maintaining health, independence, and quality of life in people living with MS.

Walking problems in MS are often caused by a combination of typical symptoms, such as altered function of muscles, nerves, and senses. The key to improving mobility is, therefore, to use a range of different treatment techniques which address each of these symptoms.

Foot sensation plays an important role in keeping the body upright and balanced whilst walking, yet, we know from previous studies that people with MS often have poor sensation on the soles of their feet. It is, therefore, possible that wearing a specially designed shoe insole, which enhances sensory information at the feet, could help people affected by MS to walk better. This would offer health care professionals a new, additional treatment technique to help manage walking problems in MS.

This study will explore whether long-term wear of a textured shoe insole can improve walking in people with MS. We will analyse how people with MS walk over an even and uneven surface, when they are wearing the insoles for the first time, and after wearing the insoles for three months. We will explore whether wearing the insoles changes the way the body moves, or the leg and trunk muscles work during walking. We will also monitor any changes in the perception of foot sensation and the awareness of foot position, to help us better understand how our insoles may bring about their effects on walking. Participants in the study will be randomly assigned to either the control insole or textured insole group.

This study could lead to the development of a new treatment technique for people with MS, specifically an inexpensive, easy-to-administer shoe insole, which could help towards improving mobility and independent living.

Inclusion criteria

Men and women aged over 18 years, with a clinical diagnosis of multiple sclerosis are eligible for this trial. They must meet the following criteria: disease steps grading 1-4 (to be assessed during a clinical screening examination); and ambulant over 100 metres with or without the use of an assistive device (cane/crutch).

Exclusion criteria

  • Neurological conditions other than Multiple Sclerosis;
  • Peripheral neuropathy;
  • Currently being prescribed over-the-counter or custom-made foot orthoses;
  • Cardiovascular or orthopaedic conditions including recent injury to the back or legs limiting ambulation;
  • Unstable psychiatric condition;
  • Cognitive impairment.

Participants who report a formal exacerbation of Multiple Sclerosis symptoms persisting >24hrs, four weeks prior to, or at any time during, the intervention period will be excluded from the study.

Anticipated start date

June 2015

Recruitment contacts

Dr Anna Hatton
School of Health and Rehabilitation Sciences
Therapies Building (84A), The University of Queensland
St Lucia, Brisbane, QLD 4072
Email: [email protected]
Phone: 07 33654590

Further details

Full details of the trial can be found on the ANZCTR clinical trials database.

Region

QLD

Last updated

March 2018

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