Clinical trial NCT04344223: Effect of Stabilization Shoes on Balance in Elderly
Official title: Effects of Stabilization Shoes on Balance and Walking. A Cross-over, Controlled, Randomized Single Blind Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Keywords: Postural Balance
Accidental Falls
Footwear
Stability
Force platform
Unipedal stance
Bipedal stance
Shoe
Lead sponsor: University of Burgundy
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 21
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Assessing change of the displacement surface of the center of pressure between the three sessions during static balance on a foot with open eyes
timeFrame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
measure: Assessing change of the length of the displacement of the centre of pressure between the three sessions during static balance on a foot with open eyes
timeFrame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
measure: Assessing change of the number of rebalancing gestures between the three sessions during static balance on a foot with open eyes
timeFrame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
measure: Assessing change of the displacement surface of the center of pressure between the three sessions during static balance on two feet open eyes
timeFrame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
measure: Assessing change of the length of the displacement of the centre of pressure between the three sessions during static balance on two feet open eyes
timeFrame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
measure: Assessing change of the average speed of the displacement of the centre of pressure between the three sessions during static balance on two feet open eyes
timeFrame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
measure: Assessing change of the number of rebalancing gestures between the three sessions during static balance on two feet open eyes
timeFrame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Secondary outcomes:
measure: Assessing change in walking capacity between the three sessions
timeFrame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
measure: Assessing change in stability limits between the three sessions at 0°
timeFrame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
measure: Assessing change in stability limits between the three sessions at 45°
timeFrame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
measure: Assessing change in stability limits between the three sessions at 90°
timeFrame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
measure: Assessing change in stability limits between the three sessions at 135°
timeFrame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
measure: Assessing change in stability limits between the three sessions at 180°
timeFrame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
measure: Assessing change in stability limits between the three sessions at 225°
timeFrame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
measure: Assessing change in stability limits between the three sessions at 270°
timeFrame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
measure: Assessing change in stability limits between the three sessions at 315°
timeFrame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
measure: Subjective assessment of the comfort linked to the wearing of the experimental balance shoes
timeFrame: Measured after wearing experimental balance shoes for a week (familiarization's period)
measure: Subjective assessment of the aesthetics linked to wearing of the experimental balance shoes
timeFrame: Measured after wearing experimental balance shoes for a week (familiarization's period)
measure: Subjective assessment of the stability linked to wearing of the experimental balance shoes
timeFrame: Measured after wearing experimental balance shoes for a week (familiarization's period)
measure: Subjective assessment of the safety linked to wearing of the experimental balance shoes
timeFrame: Measured after wearing experimental balance shoes for a week (familiarization's period)
measure: Assessing change of the displacement surface of the center of pressure between the three sessions during static balance on two feet closed eyes
timeFrame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
measure: Assessing change of the length of the displacement of the centre of pressure between the three sessions during static balance on two feet closed eyes
timeFrame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
measure: Assessing change of the average speed of the displacement of the centre of pressure between the three sessions during static balance on two feet open eyes
timeFrame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
measure: Assessing change of the number of rebalancing gestures between the three sessions during static balance on two feet open eyes
timeFrame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre d'Expertise de la Performance - Université de Bourgogne
state: Côte d'Or
Study officials:
References: