Effect of Stabilization Shoes on Balance in Elderly

NCT ID: NCT04344223

Last Updated: 2020-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2020-02-29

Brief 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

Elderly

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Experimental balance shoes

Tests and familiarization phases with experimental balance shoes (Axis Comfort Development®)

Group Type: EXPERIMENTAL

Balance Shoe

Intervention Type: DEVICE

Use of experimental balance shoes for carrying out the tests along the three sessions and one of the two familiarization phases

Personal shoes

Same tasks than the condition "Experimental balance shoes" but realized with personal shoes (own personal shoes of subjects)

Group Type: ACTIVE_COMPARATOR

Personal Shoe

Intervention Type: DEVICE

Use of Personal shoes (the same for each session) for carrying out the tests along the three sessions and one of the two familiarization phases

Interventions

Balance Shoe

Use of experimental balance shoes for carrying out the tests along the three sessions and one of the two familiarization phases

Intervention Type: DEVICE

Personal Shoe

Use of Personal shoes (the same for each session) for carrying out the tests along the three sessions and one of the two familiarization phases

Intervention Type: DEVICE

Other Intervention Names

Axis Comfort Development® Experimental Balance shoes; Own personal shoes of subjects

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Burgundy

OTHER

Sponsor Role: lead

Responsible Party

Nicolas Babault

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centre d'Expertise de la Performance - Université de Bourgogne

Dijon, Côte d'Or, France

Countries

France

Other Identifiers

CEP2001

Identifier Type: -

Identifier Source: org_study_id