Clinical Trials Directory

Trials / Completed

CompletedNCT04344223

Effect of Stabilization Shoes on Balance in Elderly

Effects of Stabilization Shoes on Balance and Walking. A Cross-over, Controlled, Randomized Single Blind Study.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
21 (actual)
Sponsor
University of Burgundy · Academic / Other
Sex
All
Age
65 Years – 75 Years
Healthy volunteers
Accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DEVICEBalance ShoeUse of experimental balance shoes for carrying out the tests along the three sessions and one of the two familiarization phases
DEVICEPersonal ShoeUse of Personal shoes (the same for each session) for carrying out the tests along the three sessions and one of the two familiarization phases

Timeline

Start date
2019-06-01
Primary completion
2020-02-15
Completion
2020-02-29
First posted
2020-04-14
Last updated
2020-04-14

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04344223. Inclusion in this directory is not an endorsement.