Effect of Stabilization Shoes on Balance in Elderly

NCT04344223 | Completed

• 1 other identifier: CEP2001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Keywords

Postural Balance; Accidental Falls; Footwear; Stability; Force platform; Unipedal stance; Bipedal stance; Shoe

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (17)

• Assessing change in walking capacity between the three sessions

  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°

  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°

  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°

  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°

  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

Study Arms (2)

Experimental balance shoes

EXPERIMENTAL

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

Device: Balance Shoe

Personal shoes

ACTIVE COMPARATOR

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

Device: Personal Shoe

Interventions

Balance Shoe DEVICE

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

Also known as: Axis Comfort Development® Experimental Balance shoes

Experimental balance shoes

Personal Shoe 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

Also known as: Own personal shoes of subjects

Personal shoes

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Burgundy: lead

Study Sites (1)

Centre d'Expertise de la Performance - Université de Bourgogne

Dijon, Côte d'Or, 21078, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data and statistical analyses
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 14, 2020
• Study Start: June 1, 2019
• Primary Completion: February 15, 2020
• Study Completion: February 29, 2020
• Last Updated: April 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)