Clinical trial NCT04477408: Effect of Plantar Sensory Exercises on Balance and Fall Risk in Nursing Home Elderly
Official title: Effect of Plantar Sensory Exercises on Balance and Fall Risk in Nursing Home Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Balance; Distorted
Plantar
Falling
Elderly
Sensitivity
Keywords: plantar sensation, balance, fall, elderly
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 20
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: self controlled prospective study
Primary purpose: TREATMENT

Brief summary: The most important cause of mortality and morbidity with the geriatric population is loss of balance and the consequent falls, which is seen very often. The goal of our study is to examine the effects of plantar sensation education-based exercises on balance and falls.Materials and methods: 16 healthy, voluntary nursing home residents with the average age 77.50±5.5. Individuals had plantar sensory exercises 40 min sessions for 3 days/week during eight weeks. The study was planned as a self-controlled prospective study. Functional balance was evaluated using Berg Balance Scale, dynamic balance was evaluated using 30 Second Chair Stand Test, static balance and fall risk were assessed using Biodex Balance System.

Detailed description: The study was run in Istanbul Provincial Directorate of Social Services Istanbul Prof. Dr. Fahrettin Kerim-Nilüfer Gökay Nursing Home Elderly Care and Rehabilitation Center in March-June 2019. This study was designed as a self-controlled prospective non-randomized study.

Written informed consent was obtained from all participants. The necessary ethical approval for the study was taken from the Medipol University Non-Interventional Clinical Research Ethics Comittee This study was planned to be run with 20 healthy nursing home residents. The criteria of being included in the study were: being above 70 years of age, scoring at least 22 points on the Mini Mental Test, not being bound to a wheelchair, being able to walk 20 meters independently, and that the sensation of the foot sole is at least on the decreased protective level compare to Semmes Weinstein Monofilamnet test. The individuals with serious loss of eyesight, mental retardation, a schizophrenic background, having walking disorder, inconvenient in walking were not included in the study.

16 healthy aged individuals with the average age of 77.50±5.5 participated in our study. 2 of the first 20 participants left the study due to health problems and 2 other participants left due to personal reasons which they did not want to declare (Figure 1).

A homogeneous control group could not be created due to aging, so a control group was created with the same participants. The first evaluations of our study were made within two days. After the evaluation process, 4 weeks waiting period was given. At the end of this period, second measurements were made for two days. Plantar sensory based exercises program lasting 8 weeks was applied after the second measurements were taken. Post-treatment measurements were made for two days after the treatment ended. Measurements were made with MC and the physiotherapist working in the nursing home.

Eligibility criteria: Inclusion Criteria:

* Being above 70 years of age
* Scoring at least 22 points on the Mini Mental Test
* Not being bound to a wheelchair
* Being able to walk 20 meters independently
* That the sensation of the foot sole is at least on the decreased protective level compare to Semmes Weinstein Monofilamnet test.

Exclusion Criteria:

* Serious loss of eyesight
* Mental retardation
* A schizophrenic background
* Having walking disorder
* Inconvenient in walking

Primary outcomes:
measure: Biodex Balance System - Static Balance
timeFrame: 0 week
measure: Biodex Balance System - Static Balance
timeFrame: 4 week
measure: Biodex Balance System - Static Balance
timeFrame: 12 week
measure: Biodex Balance System - Fall Risk
timeFrame: 0 week
measure: Biodex Balance System - Fall Risk
timeFrame: 4 week
measure: Biodex Balance System - Fall Risk
timeFrame: 12 week
Secondary outcomes:
measure: Berg Balance Scale
timeFrame: 0 week
measure: Berg Balance Scale
timeFrame: 4 week
measure: Berg Balance Scale
timeFrame: 12 week
measure: 30 Second Chair Stand Test
timeFrame: 0 week
measure: 30 Second Chair Stand Test
timeFrame: 4 week
measure: 30 Second Chair Stand Test
timeFrame: 12 week
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: İstanbul Medipol University
state: Kavacık
Study officials:
affiliation: İstanbul Medipol University
name: Müyesser Cavlak
role: STUDY_CHAIR
affiliation: İstanbul Medipol University
name: Candan Algun, Prof
role: STUDY_DIRECTOR
References: