The Effects of Plantar Sensory Based Physiotherapy Interventions on Balance and Fallings of Nursing Home Elderly

NCT04140656 | Completed

• 1 other identifier: 10840098-604.01.01-E52392
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Aging in all living things is defined as a normal physiological process that causes a decrease in realistic body function. According to the World Health Organization; It is classified as 65 years old and older and 85 years old and older (1). Characteristics of aging; decrease in reserve capacity of organ systems, decrease in homeostatic control, decrease in adaptability to environmental factors, decrease in stress response capacity (3). Stability is defined as postural stimulation against changes in the center of gravity during rest and activity. Postural answers that provide this harmony; vestibular, proprioceptive and visual data in the central nervous system. In older people, static balance can be maintained for a longer period of time, while dynamic balance may deteriorate more quickly. Aging-affected muscle strength, joint mobility, proprioceptive, vestibular and visual loss also make postural control difficult to achieve. Although the physiological mechanism underlying the risk of loss of equilibrium and falls is multifaceted, it is mostly caused by somatosensory sensitivity and decreased neuromuscular capacity (3-5). It has been determined that one third of the elderly individuals living in the society have fallen at least once a year and these rates have been stated to increase to 60% in nursing homes. Falls cause long-term disability, stay in nursing homes, in the absence of a serious injury as a result of falling, there is a fear of falling, which causes a limitation in activities of daily living. Due to the physiology of aging, it is stated that peripheral sensation decreases in older ages (12). Mold showed that bilateral somatosensorial disorder was present in approximately 26% of individuals aged 65-74, 36% of those aged 75-84, and 54% of those aged 85 years (13). In the literature, it was reported that plantar sensory loss in the elderly affects balance, mobility and gait and is a risk factor for falls (14). Different senses can be sensed by sensing receptors during the exercise program to increase sensory perception. Aerobic and strengthening exercise, feedback, virtual reality have been used in the studies on balance and falling seen in the elderly in recent years. However, a program aimed at increasing plantar sensation and it has not been found in the literature. In this study, physiotherapy programs aimed at increasing plantar sensation in the elderly will be compared.

Conditions

Balance; Distorted; Falling

Keywords

elderly; balance; falling; plantar sensitivity; insole

Outcome Measures

Primary Outcomes (8)

• Pedobarographic investigation

  By means of pressure sensors in force platforms, foot pressure is detected and transferred to computer environment. Static and dynamic measurement is also possible. Plantar pressure can be measured as total and divided areas and it will be combined to report g/cm2. Plantar contact area can be measured as total and divided areas and it will be combined to report cm2.

  day 0 (before intervention)

• Pedobarographic investigation

  By means of pressure sensors in force platforms, foot pressure is detected and transferred to computer environment. Static and dynamic measurement is also possible. Plantar pressure can be measured as total and divided areas and it will be combined to report g/cm2. Plantar contact area can be measured as total and divided areas and it will be combined to report cm2.

  4 weeks

• Pedobarographic investigation

  By means of pressure sensors in force platforms, foot pressure is detected and transferred to computer environment. Static and dynamic measurement is also possible. Plantar pressure can be measured as total and divided areas and it will be combined to report g/cm2. Plantar contact area can be measured as total and divided areas and it will be combined to report cm2.

  12 weeks

• Pedobarographic investigation

  By means of pressure sensors in force platforms, foot pressure is detected and transferred to computer environment. Static and dynamic measurement is also possible. Plantar pressure can be measured as total and divided areas and it will be combined to report g/cm2. Plantar contact area can be measured as total and divided areas and it will be combined to report cm2.

  16 weeks

• Biodex Balance System

  It is a multi-axis device which objectively measures the balance of the person in static state or under dynamic stress and records the measurement results. The Biodex Balance System permits a 20 ° inclination of the foot platform in all directions. Thus, it provides maximum stimulation of the mechanical sensors in the ankle. Biodex Balance System measurements are calculated in degrees for each direction It can be done by creating a dynamic environment for the measurement of fall risk on the same platform .

  day 0 (before intervention)

• Biodex Balance System

  It is a multi-axis device which objectively measures the balance of the person in static state or under dynamic stress and records the measurement results. The Biodex Balance System permits a 20 ° inclination of the foot platform in all directions. Thus, it provides maximum stimulation of the mechanical sensors in the ankle. Biodex Balance System measurements are calculated in degrees for each direction It can be done by creating a dynamic environment for the measurement of fall risk on the same platform .

  4 weeks

• Biodex Balance System

  It is a multi-axis device which objectively measures the balance of the person in static state or under dynamic stress and records the measurement results. The Biodex Balance System permits a 20 ° inclination of the foot platform in all directions. Thus, it provides maximum stimulation of the mechanical sensors in the ankle. Biodex Balance System measurements are calculated in degrees for each direction It can be done by creating a dynamic environment for the measurement of fall risk on the same platform .

  12 weeks

• Biodex Balance System

  It is a multi-axis device which objectively measures the balance of the person in static state or under dynamic stress and records the measurement results. The Biodex Balance System permits a 20 ° inclination of the foot platform in all directions. Thus, it provides maximum stimulation of the mechanical sensors in the ankle. Biodex Balance System measurements are calculated in degrees for each direction It can be done by creating a dynamic environment for the measurement of fall risk on the same platform .

  16 weeks

Secondary Outcomes (12)

• Berg Balance Scala

  day 0 (before intervention)

• Berg Balance Scala

  4 weeks

• Berg Balance Scala

  12 weeks

• Berg Balance

  16 weeks

• 30 Second Chair Stand Test

  day 0 (before intervention)

Study Arms (2)

Plantar sensitive exercise group

ACTIVE COMPARATOR

Plantar sensitive exercises:

Other: Plantar sensitive exercises

Textured insole group

ACTIVE COMPARATOR

Textured insole group

Other: Textured insole

Interventions

Plantar sensitive exercises OTHER

Plantar sensitive exercises: 40 minutes / 3 days per week / 8 weeks Warm up exercise (5 minute) Walking on different 4 different textured floors and hot floor (15 minute) Trying to recognize small objects with the soles of the feet (5min) Seated work with barbed ball and balance pad (5min) Massage to the sole of the foot with different textured fabrics (5min) Cooling exercise (5 min)

Plantar sensitive exercise group

Textured insole OTHER

Textured insole group. Plantar sensitive exercises with insole 40 minutes / 3 days per week / 8 weeks (all exercises will be done with insoles) Warm up exercise (5 minute) Walking on flat ground (15 minute) Exercise with roller under the sole of the foot (5 minute) Seated work with barbed balance pad (5 min) Dorsi flexion and plantar flexion and hip flexion exercises (5min). Cooling exercise (5 min)

Textured insole group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Voluntariness
• years and older
• Cognitive functions are sufficient for communication (MM score 22 and above)
• meters independent walk
• The soles of the soles are at least at the reduced protective sensory level

You may not qualify if:

• Severe visual loss
• A history of mental retardation or schizophrenia
• Person has any problems to prevent walking

Sponsors & Collaborators

• muyesser cavlak: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

Study Officials

• Candan ALGUN, Prof

  Medipol University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Muyesser CAVLAK

Model Details: The study was planned as a randomized controlled clinical trial; by simple randomization method, cases will be divided into two groups. There are 40 elderly people in the nursing home to be studied. Study was planned as group 1 and group 2. 40 minutes / 3 days per week / 8 weeks long program will be applied to both groups. Four weeks after the first measurement, the second measurement was performed. After the second measurement, rehabilitation program was started in both groups. After the 8-week program is finished, the third measurements will be made. After the third measurements, the fourth measurement will be done 4 weeks later for late results. The measurements are as follows: Primary results: electronic pedobarography device for static and dynamic base pressure changes. Biodex balance test for measuring fall risk and static stability. For secondary results; 30 second Chair stand test, Berg balance scale, Semmes weinstein monofilament test.

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 28, 2019
• Study Start: June 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: October 1, 2020
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

TU (1)