Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05409534 |
| Other study ID # |
AYSE TORAMAN KARAGULMEZ |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 18, 2022 |
| Est. completion date |
June 29, 2024 |
Study information
| Verified date |
May 2023 |
| Source |
Bulent Ecevit University |
| Contact |
Ayse T KARAGÜLMEZ |
| Phone |
05058892038 |
| Email |
fzttoraman[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
The data of the research will be collected by face to face interview technique with elderly
individuals living in Zonguldak Center, Kdz.Ereğli İzmirlioğlu, Devrek and Çaycuma nursing
homes and meeting the inclusion criteria. In order to collect data, the "Informed Consent
Form" prepared by the researcher in line with the literature will be signed by the
participant and the participant's consent will be obtained. As Evaluation Methods; For
socio-demographic status, Demographic Information Form, for evaluation of foot deformities
and problems; Foot deformity and problems evaluation form, for disease status, Charslon
Comorbidity Score for cognitive status; Standardized Mini Mental State Test for fall risk and
balance assessment; Timed Get Up and Go Test for walking speed; 10 meters Forward Walk Test,
3 meters Back Walk Test, for functional capacity evaluation; Six Minute Walking Test for
evaluation of dyspnea and fatigue severity; Modified Borg Scale for evaluation of foot
biomechanics; Evaluation of Ankle Joint Position Sense, Foot Posture Index, Foot Function
Index, for lower extremity muscle strength; Chair Sit-Up Test for fear of movement and fear
of falling; Tampa Kinesiophobia Scale, International Fall Activity Scale will be used.
All tests will be carried out in the infirmary section of nursing homes, and 1 doctor, 2
nurses and equipment will be available during the practices in case of any health problems.
Older adults will be evaluated by a single physical therapist with 16 years of clinical
experience. All assessments will be made by the same physiotherapist. During the
administration phase of the tests, a paramedic will assist in the study by standing close to
the individual in case of any fall. During the application of the tests, individuals will be
asked to wear the most appropriate clothes in line with their possibilities, which will make
them feel comfortable, not hinder their movements. On the same day, evaluations regarding
kinesiophobia and foot biomechanics will be applied to individuals. In order to minimize the
effect of fatigue, tests for functional performance (timed get up and go test, 10 m forward
and 3 m back walking test) will be performed on different days during the week, and the
evaluations will be completed within three days.
With inspection and palpation, problems in the dominant and non-dominant feet of the
individual will be recorded in the anterior, posterior and lateral view. Foot deformities
such as hallux valgus, claw toe, hammer toe, mallet finger and foot problems such as
calluses, dry skin and nail fungus in the participants will be evaluated and recorded.
The comorbidity score will be calculated with the "Charlson Comorbidity Index (CKI)". The
scale includes 19 comorbidity scores defined according to the International Classification of
Diseases 9 Clinical Modification diagnostic codes. All CKI scores are scored between 0-37.
According to the results, 3 comorbidity levels are defined as low (0), moderate (1-2) and
high (3+). The Standardized Mini Mental Test score will be taken into account to obtain
information about the cognitive status of the participants. In this test, scores below
seventeen are considered severe dementia, scores between 18-23 are considered mild dementia,
and scores between 24-30 are considered normal. Universal goniometer, which is one of the
valid and reliable methods used in the literature, will be used in the evaluation of ankle
joint position sense of individuals. During the test, measurements will be performed by
placing the pivot of the universal goniometer 1.5 cm below the lateral malleolus, the fixed
arm parallel to the long axis of the fibula, and the movable arm parallel to the long axis of
the 5th metatarsal, while the individuals are in the supine position, with their eyes closed
to avoid visual cues. In addition, care will be taken that the goniometer does not come into
contact with the individual during the measurements. Desired target angles will be determined
as 10 degree dorsiflexion (DF), 10 degree plantar flexion (PF), and 20 degree PF. Individuals
will be told to focus on the position of the ankle joints in space for 5 seconds by bringing
their feet in the neutral position to the target position, and by repeating this process 3
times, the patient will learn this position. Then, the individual will be asked to repeat the
target angle during the testing phase. Measurements will be repeated 3 times for each target
angle. As a result criterion; recording the absolute value of the deviation amounts from the
target angles; The average of the deviations occurring during the 3 repetitions will be
taken.
Posture analysis of the foot will be made using the Foot Posture Index. Foot Posture Index;
It will be evaluated according to palpation of the talus head in the posterior part of the
foot, observing the inclination above and below the lateral malleolus, inversion/eversion of
the calcaneus, presence of ballooning in the talonavicular joint region of the forefoot,
medial longitudinal arch structure, and whether the anterior part of the foot is in
abduction/adduction with respect to the posterior part of the foot. The interpretation of the
test score will be done as follows; zero will indicate the neutral position of the foot,
positive values will indicate the presence of pronation in the foot, and negative values will
indicate the presence of supination in the foot.
The sit-stand test will be used to evaluate the lower extremity muscle strength of
individuals. For the sit-stand test on a chair; A chair with a seat height of 43.18 cm,
without armrests, with a straight back and a stopwatch will be used. The individual will
start the test with the start command and will sit on the chair for 30 seconds. The exact
number of starts during the thirty-second period will be recorded as the individual's score.
Foot Function Index is an inquiry form consisting of three sub-scales and filled by the
individual himself. The Foot Function Index consists of a total of 23 questions, 9 assessing
foot pain, 9 assessing disability, and 5 assessing activity limitation. Participants are
asked to score all questions with a visual analog scale scaled from 0 to 10, taking into
account their foot condition in the last week. Each Pain, disability, activity limitation
scores and total scores for the foot will be calculated and recorded.
In the Tampa Kinesiophobia Scale, which consists of seventeen items, a 4 point likert scale
was used for each item. Each item offers scoring alternatives ranging from 'strongly
disagree' to 'strongly agree'. The total score is calculated after reversing the individual
scores of items 4, 8, 12 and 16. Scoring ranges from 17 to 68. The cut off rate in scoring is
37, and scores below or less than 37 indicate low levels of kinesiophobia, while scores above
37 indicate high levels of kinesiophobia.
The International Falling Efficiency Scale includes 16 items scored on a 4 point scale
(1=never worry, 4=very worried). The total score is scored between 16 (no anxiety) and 64
(extreme anxiety). The cut off point is 24 points to distinguish between people with a fear
of falling and those without a fear of falling.
The Timed Up and Go Test is a commonly used test to evaluate balance disorders and to
determine the risk of falling in the elderly. 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 (sec). A shorter
time indicates better balance and mobility. The test starting position should be
standardized. In this study, the test will be started with the individual's feet flat on the
floor and the arms resting on the armrest of the chair. Three repetitions will be performed
and the average of the three measurements will be recorded.
The 10-meter walking test will be used to evaluate the forward walking speed. In this test,
the person walks at his/her normal speed in a pre-measured 10 meter area. Individuals will be
given a warm-up distance of 3 meters to continue walking before 10 meters and 3 meters after
10 meters. The time starts when the person's foot is on the starting line of the 10-metre
field and ends when he crosses the finish line. The time it takes to cover the ten meters at
the person's normal speed will be recorded. The test is performed twice, and the average
value is recorded with a stopwatch in m/s.
Backward walking speed will be evaluated with the 3 Meter Backward Walk Test. Colored tapes
will be marked to determine the start and end line of the 3 meter area. Individuals will be
asked to position their heels at the level of the horizontal band at the starting line.
Individuals will be allowed to look back if they so desire. Participants will be instructed
to be as fast as possible, as well as walk backwards and stop at the finish line as
confidently as possible. The person administering the test will walk backwards with the
participant. The test is performed once and its duration is recorded in m/s with a stopwatch.
In order to evaluate the functional exercise capacity of the individuals participating in our
study, the 6-minute walking test (6MWT) will be applied to the individuals in accordance with
the criteria of the American Thoracic Society. The individual will be asked to walk as much
as possible at their own walking pace for six minutes on a 30-meter straight corridor. If the
individual feels that he or she is unable to continue the test (such as severe dyspnea, leg
pain), the individual will be told that the test will be terminated. Before starting the
test, heart rate and blood pressure will be measured. At the end of the test, the assessments
made before starting the test will be repeated. The walking distance of the individual will
be recorded by marking the point where the test was terminated .
Modified Borg Scale will be used to evaluate the severity of dyspnea and fatigue perceived by
the individual before and after the six-minute walk test. The fact that the severity of
dyspnea is defined in the Modified Borg Scale makes it easier for patients to apply. This
scale consists of ten items that define the severity of dyspnea according to their degrees.
For socio-demographic status, for demographic information form and disease status, Charslon
Comorbidity Score will be evaluated only before treatment, all remaining assessments will be
made twice, before treatment and after end of the treatment. Random assignment to
intervention and control groups will be made by a statistician to avoid randomization and
selection bias in the study. Participants will be included in the intervention and control
groups according to random assignments after the pre-test application.Within the scope of the
study, the sense of joint position of the participants will be evaluated with "Universal
Goniometer", walking speed "Digital Stopwatch", walking ritms "Cherub Analog Metronome
(WSM-330)", blood pressure "Sphygmomanometer (Omron M3 HEM-7155-E)".
The heart rate and blood pressure of the exercise group will be measured twice, before and
after exercise. Pre-exercise heart rate and blood pressure measurement will be measured 1 cm
above the elbow in the sitting position, after the individual has rested for at least 15
minutes. The post-exercise measurement will be measured from the same place as soon as the
backward walking training is finished. "Sphygmomanometer (Omron M3 HEM-7155-E)" will be used
for measurement of heart rate and blood pressure.Borg Scale will be used to determine
exercise intensity. The perceived difficulty scale (Borg) includes numbers from 6 to 20 and
corresponding difficulty expressions for these numbers.
A training program on the importance of physical activity in the elderly, prepared in line
with the Turkish Physical Activity Guidelines, will be given to all participants once (in 2
sessions/30 min + 30 min) at the beginning of the study.
The heart rate and blood pressure assessments of the Backward Walking Training Group
(Exercise Group) before and after each exercise will be made and the perceived difficulty
levels during and after the exercise will be questioned. The Borg Scale will be explained to
the individuals in the exercise group and it will be explained in detail how to indicate the
level of difficulty they perceive during the exercise.
Backward walking training will consist of unimpeded gait training with or without a cane in a
marked 15-meter area, on a flat surface, in optimal posture. If the individual cannot attend
two sessions, these sessions will be added to the end of the 8-week exercise program and all
participants will receive a total of 16 sessions. Beats per minute or bpm is the unit used to
determine tempo in music. In the studies conducted in the following years, it was reported
that the 60 bpm tempo in the forward and backward step tests was more easily tolerated by the
elderly compared to the 120 bpm and 40 bpm tempos. As far as we know, there is no metronome
tempo used during backward walking training of elderly individuals in the literature.
Therefore, in our study, 50 bpm will be chosen as the starting pace, taking into account the
recommended interval in the backward step tests and considering that backward walking is more
difficult than forward walking. Our study is unique in that it presents backward walking
training with a tempo. In order to ensure program progress in backward walking training, the
tempo of the metronome will change in the range of 50-65 bpm during the 8-week training
period. In the first week of the training, the tempo of the metronome will start at 50 bpm,
and the tempo of the metronome will be increased by 5 bpm every 3 weeks and the program will
end at 65 bpm. If the individual cannot tolerate the increase in the metronome tempo during
the program progress, he/she will be able to continue his/her training at the current
metronome tempo.
Before starting the backward walking training, participants will be given 10-minute warm-up
exercises (breathing exercises (5 times), active ankle exercises (writing the alphabet in the
sitting position, once) and standing still (2 minutes) exercise. During the movement, they
will be asked to match their steps in accordance with the tempo of the metronome. While
matching the tempo, the participant will be guided to alternately step with both right and
left feet. Each exercise session will be individually supervised by a physiotherapist and a
participant. In addition, participants will be walking backwards, standing upright. They will
be encouraged to stop and look straight ahead. The training will be held in the corridor near
the wall, and in case of any balance problem, the individual will be advised to "slow down
and concentrate" . t will be allowed to receive support. The physiotherapist will walk a
little behind the participant during the entire session, stay in close vicinity of the
participant throughout the entire session and keep the participant under close surveillance.
A chair will be available nearby to be used in case of need during the session. A session
will last a maximum of 40-50 minutes, including warm-up exercises (10 minutes), backward
walking training and cool-down exercises (10 minutes), depending on the participant's
tolerance. The maximum time to climb in backward walking training will be 30 minutes. A
maximum of 6 sets will be performed in five-minute periods, and no more than 6 sets will be
performed. The tolerance of the participant will be taken into account in increasing the
number of sets. The rest break between sets will be 2-3 minutes or as needed, and individuals
will be allowed to sit while resting between sets. However, the rest breaks provided
according to the discretion of the physiotherapist and the tolerance of the individuals to
the activity during the gait training may be specific to the individual's needs. If
individuals report that they can tolerate the increased backward walking time, the program
will progress by increasing the number of sets.
After each session, the distance walked by the individuals in 5-minute periods, the number of
sets and perceived difficulty levels will be recorded. In patients with complaints such as
cramping, moderate to severe pain, fatigue, dizziness, weakness and palpitation during
exercise, exercise training will be suspended and their continuation of the exercise program
will be evaluated by re-evaluation. Individual arrangements will be made in the execution of
the exercise program.
The walking training will end with cool-down exercises (10 minutes), heart rate and blood
pressure measurement. As cooling exercises; the individual will be asked to perform
stretching exercises for the lower extremity and waist muscles (Lumbal extensors, Hamstrings,
Quadriceps, Gastro-Soleus) for 10 seconds with 4 repetitions while in a long sitting
position.
To the Forward Walking Training Group(Control Group), they would apply two days a week for 8
weeks; A home program lasting 40-50 minutes in total, consisting of warm-up exercises (10
minutes), forward walking training for 30 minutes a day at the pace they feel comfortable,
and cooling-down exercises (10 minutes) will be given. In addition, the participants in the
control group will be visited once a week, and supervision will be given to the control group
in one of every two sessions. In addition, individuals in this group will be asked to keep an
activity diary, and they will be asked to write the duration of walking each week in the
activity diary.
In this context, the individuals included in the research will be assigned to the control and
experimental groups, respectively, and will be randomly selected by an expert statistician.
The sample of the study was found at the 95% confidence interval and at the level of α= 0.05.
While calculating the sample widths, since the researcher did not have any predictions about
the parameters to be used in the calculation or there is no reference study in the literature
that can be used to obtain the parameters, the "large effect sizes" defined by Cohen were
used during the calculations. The effect size was found to be effect size = 0.80. The
required sample size for the study is 52, with effect size = 0.80 for the independent sample
t-test, and the minimum number of people to provide 80% test power at 95% confidence level.
The sample size required for the study is effect size = 0.80 for the independent sample
t-test, and the number of people who will provide the 80% test power at the 95% confidence
interval is 52 in total. It was calculated as 26 people for the experimental group and 26
people for the control group. However, considering that there may be case losses, it was
aimed to reach 58 people and it was planned to recruit 29 people for each group. Dependent
variables of the study are foot posture index, foot function index, ankle joint position
sense, kinesiophobia level, balance performance, gait speed. The independent variable is the
practice of walking backwards and forwards.
The number of falls reported during the three-month period following the end of the
eight-week exercise program will be learned and recorded by calling nursing homes each week.
A fall will be defined as an unexpected event that results in the person lying on the ground,
on the ground, or lower. When questioning the fall story, all individuals will be asked,
"Have you fallen in the last 12 months?" Also it will be questioned how he/she fell if he/she
fell. It will be explained that when reporting the number of falls, falls that cannot be
stopped with good balance or mobility, such as trauma caused by a high-impact traffic
accident, should not be included. Elderly people with a history of falling in the last 12
months will be classified as "elderly people with a history of falls" and those without a
history of falling as "elderly people without a history of falls".
The study in question; According to the decision taken at the second doctoral thesis
monitoring committee thesis evaluation meeting held on 22.12.2022 at 15:00, the necessity of
including the six-minute walk test within the evaluation parameters in order to evaluate the
effectiveness of the given backward and forward walking training on the functional capacities
of the individuals was appropriate as a result of the evaluation of the first participants.
seen. Accordingly, the severity of fatigue and dyspnea perceived by the individual during the
implementation of the six-minute walk test will be evaluated with the Modified Borg Scale. In
addition, foot deformities and problems, which are thought to be closely related to foot
biomechanics, will also be evaluated observationally. The requested changes were accepted by
the Health Sciences Ethics Committee with the Decision No. 23/1349 dated 03.01.2023.
