Clinical trial NCT04140656: The Effects of Plantar Sensory Based Physiotherapy Interventions on Balance and Fallings of Nursing Home Elderly
Official title: The Effects of Plantar Sensory Based Physiotherapy Interventions on Balance and Fallings of Nursing Home Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Balance; Distorted
Falling
Keywords: elderly
balance
falling
plantar sensitivity
insole
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2019-10-28
Enrollment: 40
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pedobarographic investigation
timeFrame: day 0 (before intervention)
measure: Pedobarographic investigation
timeFrame: 4 weeks
measure: Pedobarographic investigation
timeFrame: 12 weeks
measure: Pedobarographic investigation
timeFrame: 16 weeks
measure: Biodex Balance System
timeFrame: day 0 (before intervention)
measure: Biodex Balance System
timeFrame: 4 weeks
measure: Biodex Balance System
timeFrame: 12 weeks
measure: Biodex Balance System
timeFrame: 16 weeks
Secondary outcomes:
measure: Berg Balance Scala
timeFrame: day 0 (before intervention)
measure: Berg Balance Scala
timeFrame: 4 weeks
measure: Berg Balance Scala
timeFrame: 12 weeks
measure: Berg Balance
timeFrame: 16 weeks
measure: 30 Second Chair Stand Test
timeFrame: day 0 (before intervention)
measure: 30 Second Chair Stand Test
timeFrame: 4 weeks
measure: 30 Second Chair Stand Test
timeFrame: 12 weeks
measure: 30 Second Chair Stand Test
timeFrame: 16 weeks
measure: Semmes Weinstein Monofilament Test
timeFrame: day 0 (before intervention)
measure: Semmes Weinstein Monofilament Test
timeFrame: 4 weeks
measure: Semmes Weinstein Monofilament Test
timeFrame: 12 weeks
measure: Semmes Weinstein Monofilament Test
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
affiliation: Medipol University
name: Candan ALGUN, Prof
role: STUDY_DIRECTOR
References: