NCT04477408

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 20, 2020

Completed
Last Updated

March 12, 2024

Status Verified

July 1, 2020

Enrollment Period

6 months

First QC Date

July 14, 2020

Last Update Submit

March 10, 2024

Conditions

Keywords

plantar sensation, balance, fall, elderly

Outcome Measures

Primary Outcomes (6)

  • 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.

    0 week

  • 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.

    4 week

  • 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.

    12 week

  • 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.

    0 week

  • 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.

    4 week

  • 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.

    12 week

Secondary Outcomes (6)

  • Berg Balance Scale

    0 week

  • Berg Balance Scale

    4 week

  • Berg Balance Scale

    12 week

  • 30 Second Chair Stand Test

    0 week

  • 30 Second Chair Stand Test

    4 week

  • +1 more secondary outcomes

Study Arms (1)

plantar exercise group

OTHER

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)

Other: plantar sensory exercise group

Interventions

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)

plantar exercise group

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Medipol University

Istanbul, Kavacık, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Müyesser Cavlak

    İstanbul Medipol University

    STUDY CHAIR
  • Candan Algun, Prof

    İstanbul Medipol University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: self controlled prospective study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Researcher

Study Record Dates

First Submitted

July 14, 2020

First Posted

July 20, 2020

Study Start

May 1, 2019

Primary Completion

November 1, 2019

Study Completion

April 1, 2020

Last Updated

March 12, 2024

Record last verified: 2020-07

Locations