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Effect of Stabilization Shoes on Balance in Elderly (BALAGE)

U

University of Burgundy

Status

Completed

Conditions

Elderly

Treatments

Device: Personal Shoe
Device: Balance Shoe

Study type

Interventional

Funder types

Other

Identifiers

NCT04344223
CEP2001

Details and patient eligibility

About

Movement during everyday activities most often requires stable posture. Postural control corresponds to a complex motor ability to maintain / re-establish balance and orient one's body in the environment. Postural stability and equilibrium deteriorate with age. More than 30% of people over 65 years old fall per year. Falls represent 90% of hip fractures and sometimes result in lasting psychological effects. Shoes are our direct link between the ground and our feet. Wearing shoes plays a major role in postural control. The characteristics of shoes usually worn by elderly people are identified with those of shoes known to be 'dangerous'. In order to improve stability and reduce the risk of falling for the elderly, Axis-Comfort Development® has developed "experimental balance shoes". Their shoes have technical characteristics presented in the scientific literature as beneficial for postural stability.

Therefore, the aim of this study was to investigate the effects of wearing experimental balance shoes on postural balance compared with the people's own shoes. We assumed that postural balance would be improved by experimental balance shoes in an acute way and improved by a familiarization phase.

This was a controlled, randomized, blind and cross-over study. three sessions were held in our center, each time interspersed with a phase of familiarization at home (7 to 10 days) during which the people had to wear either the experimental balance shoes or their own personal shoes. 21 volunteers in total participated in this study, all between 65 and 75 years old. Five tests were presented randomly for each session and all tests were carried out on a Huber 360 ® (LPG System, France) stabilometric platform. The mains criteria were static equilibrium on one foot and two feet (with eyes open and closed) and secondary criteria were stride frequency during the walk on the spot and stability limits.

An improvement of these multiple criteria during the different sessions would be proof of the positive effect of experimental balance shoes on postural balance in the elderly.

Enrollment

21 patients

Sex

All

Ages

65 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Subjects from 65 to 75 years old
  • Healthy subjects
  • Having given their written informed consent

Exclusion criteria

  • Subject who has fallen during the six months prior to the study.
  • Subject who moves with walking aids.
  • Subject with severe balance problems or unable to stand up without help
  • Subject who takes sedatives or sleeping pills
  • Subject with neurological disease (dizziness including turning dizziness, multiple sclerosis, Parkinson's, etc.)
  • Subject with history of heart attack
  • Subject who is short of breath when inactive.
  • Subject who has pains limiting walking and standing
  • Subject who takes neuroleptics except Anti-depressors if the treatment is long-standing and well-balanced.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

21 participants in 2 patient groups

Experimental balance shoes
Experimental group
Description:
Tests and familiarization phases with experimental balance shoes (Axis Comfort Development®)
Treatment:
Device: Balance Shoe
Personal shoes
Active Comparator group
Description:
Same tasks than the condition "Experimental balance shoes" but realized with personal shoes (own personal shoes of subjects)
Treatment:
Device: Personal Shoe

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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