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Completed

NCT Number: NCT04344223

Effect of Stabilization Shoes on Balance in Elderly

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.

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Key information

Conditions

Elderly

Age range

65 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre d'Expertise de la Performance - Université de Bourgogne

Dijon, Côte d'Or, 21078, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Balance Shoe

Device

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

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

Other names: Own personal shoes of subjects

Primary outcomes

  1. Assessing change of the displacement surface of the center of pressure between the three sessions during static balance on a foot with open eyes

    Time frame: 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

    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.

  2. 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

    Time frame: 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

    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.

  3. Assessing change of the number of rebalancing gestures between the three sessions during static balance on a foot with open eyes

    Time frame: 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

    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.

  4. Assessing change of the displacement surface of the center of pressure between the three sessions during static balance on two feet open eyes

    Time frame: 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

    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.

  5. 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

    Time frame: 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

    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.

  6. 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

    Time frame: 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

    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.

  7. Assessing change of the number of rebalancing gestures between the three sessions during static balance on two feet open eyes

    Time frame: 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

    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.

Secondary outcomes

  1. Assessing change in walking capacity between the three sessions

    Time frame: 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

    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).

  2. Assessing change in stability limits between the three sessions at 0°

    Time frame: 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

    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.

  3. Assessing change in stability limits between the three sessions at 45°

    Time frame: 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

    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.

  4. Assessing change in stability limits between the three sessions at 90°

    Time frame: 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

    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.

  5. Assessing change in stability limits between the three sessions at 135°

    Time frame: 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

    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.

  6. Assessing change in stability limits between the three sessions at 180°

    Time frame: 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

    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.

  7. Assessing change in stability limits between the three sessions at 225°

    Time frame: 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

    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.

  8. Assessing change in stability limits between the three sessions at 270°

    Time frame: 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

    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.

  9. Assessing change in stability limits between the three sessions at 315°

    Time frame: 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

    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.

  10. Subjective assessment of the comfort linked to the wearing of the experimental balance shoes

    Time frame: Measured after wearing experimental balance shoes for a week (familiarization's period)

    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

  11. Subjective assessment of the aesthetics linked to wearing of the experimental balance shoes

    Time frame: Measured after wearing experimental balance shoes for a week (familiarization's period)

    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

  12. Subjective assessment of the stability linked to wearing of the experimental balance shoes

    Time frame: Measured after wearing experimental balance shoes for a week (familiarization's period)

    The question was : "Did you feel more stable wearing Balance Shoes?" with 2 predefined answers : (1) "Yes" ; (2) "No". Questionary was anonymous

  13. Subjective assessment of the safety linked to wearing of the experimental balance shoes

    Time frame: Measured after wearing experimental balance shoes for a week (familiarization's period)

    The question was : "Did you feel safer wearing Balance Shoes?" with 2 predefined answers : (1)"Yes" ; (2) "No". Questionary was anonymous

  14. Assessing change of the displacement surface of the center of pressure between the three sessions during static balance on two feet closed eyes

    Time frame: 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

    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.

  15. 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

    Time frame: 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

    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.

  16. 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

    Time frame: 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

    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.

  17. Assessing change of the number of rebalancing gestures between the three sessions during static balance on two feet open eyes

    Time frame: 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

    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.

Sponsors and collaborators

Lead sponsor

University of Burgundy

Other

Registry information

Official study title

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

Acronym: BALAGE

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 14, 2020
Registry last updated
Apr 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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