Effect of Plantar Sensory Exercises on Balance and Fall Risk in Nursing Home Elderly
Primary Purpose
Balance; Distorted, Plantar, Falling
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
plantar sensory exercise group
Sponsored by
About this trial
This is an interventional treatment trial for Balance; Distorted focused on measuring plantar sensation, balance, fall, elderly
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
Sites / Locations
- İstanbul Medipol University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
plantar exercise group
Arm Description
plantar sensitive exercises Plantar sensitive exercises: 30 minutes / 3 days per week / 8 weeks 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)
Outcomes
Primary Outcome Measures
Biodex Balance System - Static Balance
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.
Biodex Balance System - Static Balance
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.
Biodex Balance System - Static Balance
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.
Biodex Balance System - Fall Risk
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 - Fall Risk
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 - Fall Risk
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.
Secondary Outcome Measures
Berg Balance Scale
This test evaluates the individuals' ability to maintain their balance during functional activity. Berg Balance Scale is run with 14 different activities. A score between 0-20 shows high risk, a score between 21-40 shows medium risk and a score between 41-64 shows low risk
Berg Balance Scale
This test evaluates the individuals' ability to maintain their balance during functional activity. Berg Balance Scale is run with 14 different activities. A score between 0-20 shows high risk, a score between 21-40 shows medium risk and a score between 41-64 shows low risk
Berg Balance Scale
This test evaluates the individuals' ability to maintain their balance during functional activity. Berg Balance Scale is run with 14 different activities. A score between 0-20 shows high risk, a score between 21-40 shows medium risk and a score between 41-64 shows low risk
30 Second Chair Stand Test
30 Second Chair Stand Test evaluates an individuals' dynamic balance with their activity of sitting and standing up. It is performed by asking the participant to constantly sit down and stand up from a chair within 30 seconds and noting how many times they do it.
30 Second Chair Stand Test
30 Second Chair Stand Test evaluates an individuals' dynamic balance with their activity of sitting and standing up. It is performed by asking the participant to constantly sit down and stand up from a chair within 30 seconds and noting how many times they do it.
30 Second Chair Stand Test
30 Second Chair Stand Test evaluates an individuals' dynamic balance with their activity of sitting and standing up. It is performed by asking the participant to constantly sit down and stand up from a chair within 30 seconds and noting how many times they do it.
Full Information
NCT ID
NCT04477408
First Posted
July 14, 2020
Last Updated
July 16, 2020
Sponsor
Istanbul Medipol University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04477408
Brief Title
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
April 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Balance; Distorted, Plantar, Falling, Elderly, Sensitivity
Keywords
plantar sensation, balance, fall, elderly
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
self controlled prospective study
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
plantar exercise group
Arm Type
Other
Arm Description
plantar sensitive exercises
Plantar sensitive exercises:
30 minutes / 3 days per week / 8 weeks 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)
Intervention Type
Other
Intervention Name(s)
plantar sensory exercise group
Intervention Description
plantar sensitive exercises
Plantar sensitive exercises:
30 minutes / 3 days per week / 8 weeks 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)
Primary Outcome Measure Information:
Title
Biodex Balance System - Static Balance
Description
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.
Time Frame
0 week
Title
Biodex Balance System - Static Balance
Description
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.
Time Frame
4 week
Title
Biodex Balance System - Static Balance
Description
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.
Time Frame
12 week
Title
Biodex Balance System - Fall Risk
Description
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.
Time Frame
0 week
Title
Biodex Balance System - Fall Risk
Description
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.
Time Frame
4 week
Title
Biodex Balance System - Fall Risk
Description
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.
Time Frame
12 week
Secondary Outcome Measure Information:
Title
Berg Balance Scale
Description
This test evaluates the individuals' ability to maintain their balance during functional activity. Berg Balance Scale is run with 14 different activities. A score between 0-20 shows high risk, a score between 21-40 shows medium risk and a score between 41-64 shows low risk
Time Frame
0 week
Title
Berg Balance Scale
Description
This test evaluates the individuals' ability to maintain their balance during functional activity. Berg Balance Scale is run with 14 different activities. A score between 0-20 shows high risk, a score between 21-40 shows medium risk and a score between 41-64 shows low risk
Time Frame
4 week
Title
Berg Balance Scale
Description
This test evaluates the individuals' ability to maintain their balance during functional activity. Berg Balance Scale is run with 14 different activities. A score between 0-20 shows high risk, a score between 21-40 shows medium risk and a score between 41-64 shows low risk
Time Frame
12 week
Title
30 Second Chair Stand Test
Description
30 Second Chair Stand Test evaluates an individuals' dynamic balance with their activity of sitting and standing up. It is performed by asking the participant to constantly sit down and stand up from a chair within 30 seconds and noting how many times they do it.
Time Frame
0 week
Title
30 Second Chair Stand Test
Description
30 Second Chair Stand Test evaluates an individuals' dynamic balance with their activity of sitting and standing up. It is performed by asking the participant to constantly sit down and stand up from a chair within 30 seconds and noting how many times they do it.
Time Frame
4 week
Title
30 Second Chair Stand Test
Description
30 Second Chair Stand Test evaluates an individuals' dynamic balance with their activity of sitting and standing up. It is performed by asking the participant to constantly sit down and stand up from a chair within 30 seconds and noting how many times they do it.
Time Frame
12 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Müyesser Cavlak
Organizational Affiliation
İstanbul Medipol University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Candan Algun, Prof
Organizational Affiliation
İstanbul Medipol University
Official's Role
Study Director
Facility Information:
Facility Name
İstanbul Medipol University
City
İstanbul
State/Province
Kavacık
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Effect of Plantar Sensory Exercises on Balance and Fall Risk in Nursing Home Elderly
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