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Clinical Trials/NCT04477408
NCT04477408
Completed
Not Applicable

Effect of Plantar Sensory Exercises on Balance and Fall Risk in Nursing Home Elderly

Istanbul Medipol University Hospital1 site in 1 country20 target enrollmentMay 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Balance; Distorted
Sponsor
Istanbul Medipol University Hospital
Enrollment
20
Locations
1
Primary Endpoint
Biodex Balance System - Fall Risk
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2019
End Date
April 1, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Istanbul Medipol University Hospital
Responsible Party
Principal Investigator
Principal Investigator

muyesser cavlak

Chief Researcher

Istanbul Medipol University Hospital

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

Outcomes

Primary Outcomes

Biodex Balance System - Fall Risk

Time Frame: 12 week

For evaluate to fall risk the device was used as stated in the guide manual. The test was run gradually by moving from an unstable surface to a stable surface for 20 seconds in three sets. Between each set, the participants rested for 10 seconds. A high score indicates that the fall risk is high.

Biodex Balance System - Static Balance

Time Frame: 12 week

The device calculates a score of stability or loss of balance in the anteroposterior and mediolateral direction. It also calculates an average stability index by taking the average of these two scores. The general balance index score was used which was obtained according to the protocol in the guide manual of the device. The measurement of static balance was repeated 3 times on the 8th level mode with a test duration of 30 seconds, with 15 seconds of rest periods and the best result was taken into evaluation. A high score indicates that the loss of postural control and balance is high.

Secondary Outcomes

  • 30 Second Chair Stand Test(12 week)
  • Berg Balance Scale(12 week)

Study Sites (1)

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