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

NCT ID: NCT04140656

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2020-10-01

Brief Summary

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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.

Detailed Description

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The study is planned to be conducted between the years of 2019-January-2020 for elderly people over 70 years old who live in Küçük Çamlıca Fahrettin Kerim Gökay Nursing Home. The study was planned as a randomized controlled clinical trial; By simple randomization method, cases will be divided into two groups. There are 47 elderly people over 70 years old in the nursing home to be studied. The sample size was planned to be 16 for each group.Group 1 (n:16), group 2 (n:17). 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. Thus, pilot study was made. 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.

Conditions

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Balance; Distorted Falling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Plantar sensitive exercise group

Plantar sensitive exercises:

Group Type ACTIVE_COMPARATOR

Plantar sensitive exercises

Intervention Type 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)

Textured insole group

Textured insole group

Group Type ACTIVE_COMPARATOR

Textured insole

Intervention Type 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)

Interventions

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Plantar sensitive exercises

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)

Intervention Type OTHER

Textured insole

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)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Severe visual loss
* A history of mental retardation or schizophrenia
* Person has any problems to prevent walking
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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muyesser cavlak

OTHER

Sponsor Role lead

Responsible Party

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muyesser cavlak

Muyesser CAVLAK

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Candan ALGUN, Prof

Role: STUDY_DIRECTOR

Medipol University

Locations

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Istanbul Medipol University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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10840098-604.01.01-E52392

Identifier Type: -

Identifier Source: org_study_id

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