NCT05409534

Brief Summary

Foot problems are among the most common reasons for elderly individuals to apply to health care centers. With aging, changes occur in the appearance, biomechanics, posture and function of the foot. These changes cause deterioration in balance, increase in the risk of falling, fracture formation, limitation in mobility and activities. In recent years, backward walking seems to have become a popular treatment in rehabilitation. The walking cycle, which we start with a heel strike in our normal forward walking, starts with finger contact while walking backwards. It has been stated that this situation affects the entire plantar pressure distribution and provides a more equal distribution of plantar pressure. Therefore, gait modifications seem to affect foot biomechanics. It is not yet known how backward walking training affects foot biomechanics, balance and kinesiophobia in elderly individuals. By improving the ability to walk backwards, it may be possible to improve foot functions, increase mobility function, improve balance ability, and reduce the fear of falling and the incidence of falling. In addition, this training is easy to learn and popular, and has the advantage of being low cost. The aim of this study is to evaluate the effects of backward walking training on ankle joint position sense, foot posture and functions, lower extremity muscle strength, balance, kinesiophobia status and fall incidence in elderly individuals staying in nursing homes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

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

First Submitted

Initial submission to the registry

May 28, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

February 24, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

10 months

First QC Date

May 28, 2022

Last Update Submit

August 7, 2024

Conditions

Keywords

balancefallselderlyfoot

Outcome Measures

Primary Outcomes (10)

  • Balance Performance

    Timed Get Up and Go: In the test, the person will be asked to get up from his chair, walk 3 meters at a safe and normal speed, turn, walk back and sit on the chair, accompanied by a stopwatch, and the time will be recorded in seconds. Three repetitions will be performed and the average of the three measurements will be recorded. Completion of the test in a short time means better balance performance.

    Pre test -Post test (At the end of 8 weeks treatment)

  • Lower extremity muscle strength

    Sit-Up Chair Test: The number of times the individual sits and stands in a chair during 30 seconds will be recorded as the individual's score.

    Pre test -Post test (At the end of 8 weeks treatment)

  • Kinesiophobia

    Tampa Kinesiophobia Scale:Responses on the Tampa Kinesiophobia Scale are classified as strongly disagree, disagree, agree and strongly agree. There are two types of expressions (direct and inverse) in the scale. While these expressions are scored, those who get 1 point turn into 4, and those who get 4 points turn into 1. 4-point answers in direct statements indicate a high level of kinesiophobia. In reversed expressions, answers with a value of 1 indicate a high level of kinesiophobia, and answers with a value of 4 indicate a low level of kinesiophobia. Scores from the scale range from 17 to 68. The score obtained from the scale constitutes the individual's score that should be interpreted at the level of kinesiophobia. A high score indicates a high level of kinesiophobia.

    Pre test -Post test (At the end of 8 weeks treatment)

  • Fear of Falling

    The International Falling Efficiency Scale: The answers given in the international fall efficiency scale are classified as (1) I am not worried at all, (2) I am a little worried, (3) I am very worried, (4) I am very worried. The total score is scored between 16 (no fear of falling) to 64 (excessive fear of falling).The cut-off point is 24 points to distinguish between people with a fear of falling and those without a fear of falling.

    Pre test -Post test (At the end of 8 weeks treatment)

  • Forward Walking Speed

    10 meters Forward Walk Test:The time it takes to cover the ten meters at the person's normal speed will be recorded. The test is done twice and the average value is recorded in seconds. Then, 10 meters is divided by this obtained value and recorded in meters/second.

    Pre test -Post test (At the end of 8 weeks treatment)

  • Backward Walking Speed

    3 meters Backward Walk Test:The time taken for the person to walk backwards as fast as possible will be recorded. The test is done once and its duration is recorded in seconds with a stopwatch. Then, 3 meters is divided by this obtained value and recorded in meters/second.

    Pre test -Post test (At the end of 8 weeks treatment)

  • Foot Posture

    Foot Posture İndex: The test score is calculated by assigning values between -2 and +2 to the 6 criteria on the foot and summing the scores from all criteria. A test score of 0 indicates that the foot is in a neutral position. A positive test score indicates standing pronation. A negative test score indicates standing supination.

    Pre test -Post test (At the end of 8 weeks treatment)

  • Foot Function

    Foot Function İndex:The scale consists of three subscales: pain, disability, and activity limitation. There are 23 questions in total. The participants are asked to score all questions with a visual analog scale scaled between 0-10, taking into account their foot condition in the last week. To calculate the sub-scales and the total score, the score of each item is added, divided by the sum of the maximum scores of the items and multiplied by 100. Higher scores indicate more pain, disability, and activity limitation.

    Pre test -Post test (At the end of 8 weeks treatment)

  • Ankle Joint Position Sense

    Individuals will be asked to bring their neutral feet to the desired target positions (10 degrees of dorsiflexion, 10 degrees of plantar flexion, 20 degrees of plantar flexion). Measurements will be repeated 3 times for each target angle. The absolute value of the deviations from the target angles will be recorded and the average of the deviations occurring during the 3 repetitions will be taken. A small amount of deviation from target angle means good Ankle Joint Position Sense.

    Pre test -Post test (At the end of 8 weeks treatment)

  • Functional Exercise Capacity

    Six-minute walk test: The distance traveled will be measured by walking in a straight 30-meter corridor for six minutes. More distance traveled indicates better functional capacity.

    Pre test -Post test (At the end of 8 weeks treatment)

Secondary Outcomes (2)

  • Cognitive status

    Pre test -Post test (At the end of 8 weeks treatment)

  • Fall incidence

    for three months after two months of treatment

Study Arms (2)

Backward Walking

ACTIVE COMPARATOR

Participants who walk backward gait in the form of exercise program

Other: Backward Walking (Exercise group)

Forward Walking

ACTIVE COMPARATOR

Participants who walk forward gait in the form of home program

Other: Forward Walking (Control Group)

Interventions

The participant will apply a maximum of 40-50 minutes of exercise, including 10 minutes of warm-up exercise, 30 minutes of backward walking training and 10 minutes of cooling-off exercise. The maximum time to do backward walking training will be 30 minutes. In the backward walking exercise, 1 set will take 5 minutes. The maximum number of sets that can be made will be 6 sets. No more than 6 sets will be made.

Backward Walking

The participant will apply a maximum of 40-50 minutes of exercise, including 10 minutes of warm-up exercise, 30 minutes of forward walking training and 10 minutes of cooling-off exercise as the home exercise programme.

Forward Walking

Eligibility Criteria

Age65 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Being 65 years of age and older
  • Stay in a nursing home
  • Getting a score of 24 or higher on the Standardized Mini Mental State Test
  • Being able to walk with a cane or without a cane
  • Know how to read and write

You may not qualify if:

  • Being vision problem that cannot be corrected with glasses or lenses
  • Being hear problem that cannot be corrected with hearing aids
  • Being blood pressure unsafe for exercise (\>180/100 or \<100/60 mmHg at rest)
  • Being severe respiratory and cardiac problems (previous congestive heart failure, transient ischemic attacks)
  • History of lower extremity surgery in the last six months
  • Being severe orthopedic and neurological deficits that may affect walking
  • History of recurrent falls (more than one fall in the last year)
  • Being do exercise more than 150 minutes a week
  • Participating in any exercise program in the last six months
  • Three or not participating in more exercise sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Center, Kdz. Ereğli İzmirlioğlu, Devrek and Çaycuma Nursing Homes

Zonguldak, Center, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Ayşe T KARAGÜLMEZ

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
İn this context, individuals included in the study will be assigned to the control and intervention groups respectively, randomized by an expert statistician and received in closed envelopes
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 26 for intervention 1 (Backward Walking Exercise) group and 26 for intervention 2 (Forward Walking Home Exercise) group
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 28, 2022

First Posted

June 8, 2022

Study Start

February 24, 2023

Primary Completion

January 2, 2024

Study Completion

March 29, 2024

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Since this is a doctoral thesis, it is planned to be shared after the thesis is published

Locations