The effect of cognitive-behavioral therapy on the stages of planning and predicting the time of movement in the elderly with fear of falling
Design
Clinical trial with control group, double-blind, randomized with sealed envelopes
Settings and conduct
Location of interventions in the nursing home daily.
Number of courses:one blind (evaluators)
Participants/Inclusion and exclusion criteria
Admission requirements:
Independence in daily activities
Age between 60-80 years
Fear of falling based on the Falls Efficacy Scale-International test
Able to walk at least 20 meters without aids
Exclusion criteria:
Any acute or chronic disease that affects the control of balance and gait (neuromuscular diseases, visual disorders, vestibular, etc.)
Existence of cognitive disorders (24> Mini Mental status Examination Test)
Acute psychiatric illness and psychosis
Intervention groups
Individuals in the intervention group are treated with a combination of routine walking rehabilitation as well as cognitive-behavioral therapy to reduce the fear of falling. Conventional walking rehabilitation These exercises are performed twice a week for 45 minutes for 12 weeks. Cognitive-behavioral therapy in this group aims to reduce the fear of falling and improve self-efficacy. This treatment contains various parts, including the use of positive words before and after performing a motor skill to eliminate the negative attitude and reassurance in performing the skill. This treatment is done in groups (6 to 8 people in each group) once a week for 2 hours during 12 weeks.
In the control group, normal gait is performed exactly the same as the intervention group twice a week for 45 minutes for 12 weeks.
Main outcome variables
The time difference between the mental imagination of doing movement and the actual doing of movement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211201053248N1
Registration date:2022-01-19, 1400/10/29
Registration timing:prospective
Last update:2022-01-19, 1400/10/29
Update count:0
Registration date
2022-01-19, 1400/10/29
Registrant information
Name
roghaye diveh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3324 9324
Email address
diveroghaye@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive-behavioral therapy on the stages of planning and predicting the time of movement in the elderly with fear of falling
Public title
The effect of cognitive-behavioral therapy on the elderly with fear of falling
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Fear of falling without cognitive impairment
Independence in daily activities
Able to walk at least 20 meters without aids
Ability to participate in treatment sessions
Age between 60 and 80 years
Exclusion criteria:
Any acute or chronic illness that affects balance and gait control
Existence of cognitive disorders
Acute psychiatric illness with psychosis
Age
From 60 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Envelopes are prepared for the number of participants in the study (36 people) which are placed inside 18 envelopes of odd numbers and in the remaining 18 envelopes of even numbers and then we combine the envelopes by chance and from this random combination Sample people select one of the envelopes and are divided into intervention and control groups, respectively, being even or odd.
Blinding (investigator's opinion)
Single blinded
Blinding description
This is a one-way blind study in which the statistician is an independent person who analyzes data and is unaware of the allocation of groups.
And the evaluator is an independent person and evaluates the consequences and is unaware of the allocation of groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of School of Paramedical Sciences and Health School of mashhad Mashhad University o
Street address
Mashhad, Azadi St., East Door of Ferdowsi University of Mashhad, University Campus, Faculty of Paramedical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Approval date
2021-12-11, 1400/09/20
Ethics committee reference number
IR.MUMS.FHMPM.REC.1400.061
Health conditions studied
1
Description of health condition studied
Fear of falling
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The time difference between the mental imagination of doing movement and the actual doing of movement
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Timed Up and Go Test
Secondary outcomes
1
Description
Level of fear of falling
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Falls Efficacy Scale International
2
Description
The risk of falling
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Dynamic Gait Index
Intervention groups
1
Description
The "intervention group" is treated with a combination of routine walking rehabilitation as well as cognitive-behavioral therapy to reduce the fear of falling. Common walking rehabilitation includes a number of active range-of-motion exercises for all joints of the body, progressive strengthening exercises to guide the hip extensor and abductor, knee and dorsal extensors and flexors, and plantar flexors of the ankle, as well as other skills including transition from sitting to sitting. Conversely, knee squats, standing on one foot, standing back and walking, walking on heels, walking on and off, spinning, stepping on, picking up objects while walking, and on stairs. And go down. These exercises are performed twice a week for 45 minutes for 12 weeks. Cognitive-behavioral therapy in this group aims to reduce the fear of falling and improve self-efficacy. This treatment has different parts, including the use of positive words before and after performing a skill move to build a negative attitude and reassurance in performing the skill. This positivity starts as part of simple skills and progresses to more complex motor skills over distances and less support. Another part of this method is visualizing the correct pattern of a skill before doing it. For example, a correct gait pattern in the face of an environmental disturbance is taught by the therapist and the therapist is asked to visualize the ability to do so before doing so. Another part of this treatment is to improve the self-efficacy of the individual. In this case, the person discusses in his mind these questions, 'what a great success it would be if I walked in any place of fear as in the past', how he reacts to those around me against this without progress. This treatment is done in groups (6 to 8 people in each group) once a week for 2 hours for 12 weeks.
Category
Rehabilitation
2
Description
Control group: Conventional gait rehabilitation is performed exactly the same as the intervention group twice a week for 45 minutes for 12 weeks.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Mehr Elderly Center
Full name of responsible person
Ana Jamal Ghojoghi
Street address
Next To Navid Bar, Mehr Elderly Center، Enghelab St، Basij Square
City
Gonbad Ghabos
Province
Golestan
Postal code
4979188517
Phone
+98 911 878 6929
Email
Mdade767@gmail.com
2
Recruitment center
Name of recruitment center
Hamdelan Elderly Center
Full name of responsible person
Fateme Karimi
Street address
No. 4،Corner Of Raja 10، Shahid Rajaei St.
City
AzadShahr
Province
Golestan
Postal code
4961614961
Phone
+98 17 3572 2708
Email
Karimii.Hamdelan91@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghaıor Mobarham
Street address
Faculty of Paramedical Sciences، University Campus، East Door of Ferdowsi University of Mashhad، Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3884 6710
Email
Sps.Dean@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Roghaye Dive
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Seyedniaz village
City
Gonbad Ghabos
Province
Golestan
Postal code
4977184669
Phone
+98 17 3324 9324
Email
Divehroghaye@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Asghar Hosseini
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Paramedical Sciences، University Campus، East Door of Ferdowsi University of Mashhad، Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
051 38846710_20
Email
hosseiniha@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Roghaye Dive
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Seyedniaz village
City
Gonbade Ghabos
Province
Golestan
Postal code
4977184769
Phone
+98 17 3324 9324
Email
Diveroghaye@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available