Effect of Stabilization Shoes on Balance in Elderly (BALAGE)

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

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.

Study Overview

• Status: Completed
• Conditions: Elderly
• Intervention / Treatment: Device: Balance Shoe; Device: Personal Shoe

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Côte d'Or
    • Dijon, Côte d'Or, France, 21078
      • Centre d'Expertise de la Performance - Université de Bourgogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years to 73 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental balance shoes; Tests and familiarization phases with experimental balance shoes (Axis Comfort Development®)	Device: Balance Shoe; Use of experimental balance shoes for carrying out the tests along the three sessions and one of the two familiarization phases; Other Names: Axis Comfort Development® Experimental Balance shoes
Active Comparator: Personal shoes; Same tasks than the condition "Experimental balance shoes" but realized with personal shoes (own personal shoes of subjects)	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; Other Names: Own personal shoes of subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing change of the displacement surface of the center of pressure between the three sessions during static balance on a foot with open eyes	Surface of the displacement of the centre of pressure (Value in square millimeters, mm²) during 30 seconds was measured on a Huber 360 ® (LPG System, France) force platform.	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
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	Length of the displacement of the centre of pressure (Value in millimeters, mm) during 30 seconds was measured on a Huber 360 ® (LPG System, France) force platform.	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
Assessing change of the number of rebalancing gestures between the three sessions during static balance on a foot with open eyes	Number of rebalancing gestures (with the foot or with the hand during test) during 30 seconds was measured on a Huber 360 ® (LPG System, France) force platform.	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
Assessing change of the displacement surface of the center of pressure between the three sessions during static balance on two feet open eyes	Surface of the displacement of the centre of pressure (Value in square millimeters, mm²) during 50 seconds was measured on a Huber 360 ® (LPG System, France) force platform.	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
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	Length of the displacement of the centre of pressure (Value in millimeters, mm) during 50 seconds was measured on a Huber 360 ® (LPG System, France) force platform.	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
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	Average speed of the displacement of the centre of pressure (Value in millimeters per second, mm/s) during 50 seconds was measured on a Huber 360 ® (LPG System, France) force platform.	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
Assessing change of the number of rebalancing gestures between the three sessions during static balance on two feet open eyes	Number of rebalancing gestures (with the foot or with the hand during test) during 50 seconds was measured on a Huber 360 ® (LPG System, France) force platform.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Average speed of the displacement of the centre of pressure (Value in millimeters per second, mm/s) during 50 seconds was measured on a Huber 360 ® (LPG System, France) force platform.	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
Assessing change of the number of rebalancing gestures between the three sessions during static balance on two feet open eyes	Number of rebalancing gestures (with the foot or with the hand during test) during 50 seconds was measured on a Huber 360 ® (LPG System, France) force platform.	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
Assessing change in walking capacity between the three sessions	Walk at the pace following the change of the Left (on right foot and left leg detached) and Right (opposite) visuals on the platform screen for 50 seconds. Subjects were asked to lift their feet using enough hip flexion to bring the foot halfway up the support leg. The expected number of strides was around 96. Measured on a Huber 360 ® (LPG System, France) force platform (number of strides).	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
Assessing change in stability limits between the three sessions at 0°	Maximal displacement of the centre of pressure at 0°. 8 seconds to go as far as possible (Value in degrees, °). Measured on a Huber 360 ® (LPG System, France) force platform.	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
Assessing change in stability limits between the three sessions at 45°	Maximal displacement of the centre of pressure at 45°. 8 seconds to go as far as possible (Value in degrees, °). Measured on a Huber 360 ® (LPG System, France) force platform.	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
Assessing change in stability limits between the three sessions at 90°	Maximal displacement of the centre of pressure at 90°. 8 seconds to go as far as possible (Value in degrees, °). Measured on a Huber 360 ® (LPG System, France) force platform.	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
Assessing change in stability limits between the three sessions at 135°	Maximal displacement of the centre of pressure at 135°. 8 seconds to go as far as possible (Value in degrees, °). Measured on a Huber 360 ® (LPG System, France) force platform.	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
Assessing change in stability limits between the three sessions at 180°	Maximal displacement of the centre of pressure at 180°. 8 seconds to go as far as possible (Value in degrees, °). Measured on a Huber 360 ® (LPG System, France) force platform.	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
Assessing change in stability limits between the three sessions at 225°	Maximal displacement of the centre of pressure at 225°. 8 seconds to go as far as possible (Value in degrees, °). Measured on a Huber 360 ® (LPG System, France) force platform.	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
Assessing change in stability limits between the three sessions at 270°	Maximal displacement of the centre of pressure at 270°. 8 seconds to go as far as possible (Value in degrees, °). Measured on a Huber 360 ® (LPG System, France) force platform.	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
Assessing change in stability limits between the three sessions at 315°	Maximal displacement of the centre of pressure at 315°. 8 seconds to go as far as possible (Value in degrees, °). Measured on a Huber 360 ® (LPG System, France) force platform.	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
Subjective assessment of the comfort linked to the wearing of the experimental balance shoes	The question was : "How do you feel in general wearing Balance Shoes?" with 4 predefined answers : (1) "Very comfortable" ; (2) "Comfortable" ; (3)"Normal" and (4) "Uncomfortable". Questionary was anonymous	Measured after wearing experimental balance shoes for a week (familiarization's period)
Subjective assessment of the aesthetics linked to wearing of the experimental balance shoes	The question was : "How do you find the aesthetics of Balance Shoes?" with 4 predefined answers : (1) "To my liking" ; (2) "Correct" ; (3)"Not to my liking" and (4) "No opinion". Questionary was anonymous	Measured after wearing experimental balance shoes for a week (familiarization's period)
Subjective assessment of the stability linked to wearing of the experimental balance shoes	The question was : "Did you feel more stable wearing Balance Shoes?" with 2 predefined answers : (1) "Yes" ; (2) "No". Questionary was anonymous	Measured after wearing experimental balance shoes for a week (familiarization's period)
Subjective assessment of the safety linked to wearing of the experimental balance shoes	The question was : "Did you feel safer wearing Balance Shoes?" with 2 predefined answers : (1)"Yes" ; (2) "No". Questionary was anonymous	Measured after wearing experimental balance shoes for a week (familiarization's period)
Assessing change of the displacement surface of the center of pressure between the three sessions during static balance on two feet closed eyes	Surface of the displacement of the centre of pressure (Value in square millimeters, mm²) during 50 seconds was measured on a Huber 360 ® (LPG System, France) force platform.	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
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	Length of the displacement of the centre of pressure (Value in millimeters, mm) during 50 seconds was measured on a Huber 360 ® (LPG System, France) force platform.	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

Collaborators and Investigators

• Sponsor: University of Burgundy

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): February 15, 2020
• Study Completion (Actual): February 29, 2020

Study Registration Dates

• First Submitted: April 1, 2020
• First Submitted That Met QC Criteria: April 10, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Actual): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 10, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Shoe; Stability; Postural Balance; Accidental Falls; Footwear; Force platform; Unipedal stance; Bipedal stance
• Other Study ID Numbers: CEP2001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No