1. Home
  2. Approved trials
  3. » فارسی

The Effect of Frenkel Exercises on gait disturbance and Fear of Fall in Aged Patients with balance disorders: A Parallel Randomized Clinical Trial

Protocol summary

Study aim
Determining the effect of Frankel exercise on gait disturbance and fear of falling in the elderly with balance disorder
Design
A clinical trial with a control group, with parallel groups, randomized on 100 patients, rand function of Excel software was used for randomization.
Settings and conduct
The elderly will be selected based on the researcher's criteria and by sequential sampling method in Tasua Babol clinic and will be grouped into blocks of 4 based on the randomization software and then will be assigned to the intervention group and the control group. Patients exercise for 30 minutes five days a week for six weeks.
Participants/Inclusion and exclusion criteria
Entry requirements: Age over 65 years, Having a confidential family caregiver between 18 and 60 years old, According to the results of the Romberg test, have balance problems, Having independence based on the KATZ Basic ADL questionnaire (a person enters the study with a score of 5 or 6. Non-entry conditions: Cognitive impairment based on the MMSE questionnaire, a person with a score of 18 and above is included in the study, Regularly or irregularly used sports for balance during the last six months, Existence of medical contraindications to exercise, such as chest pain, shortness of breath, extreme fatigue, severe muscle and joint pain, disability, deformity, and heart palpitations. The presence of destructive progressive neurological disorders such as dementia and Parkinson's that interfere with the ability to exercise.
Intervention groups
In the intervention group, balance exercises are used according to Frenkel's exercises, which include learning how to turn, sit and stand up using different everyday objects such as a chair, bed, or painted footprints on the floor. In the control group, routine care is applied.
Main outcome variables
Fear of Fall; gait disturbance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221120056554N1
Registration date: 2023-01-07, 1401/10/17
Registration timing: prospective

Last update: 2023-01-07, 1401/10/17
Update count: 0
Registration date
2023-01-07, 1401/10/17
Registrant information
Name
Hamed Salahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 9699
Email address
hamedsalahi9776@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-15, 1401/10/25
Expected recruitment end date
2023-01-30, 1401/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Frenkel Exercises on gait disturbance and Fear of Fall in Aged Patients with balance disorders: A Parallel Randomized Clinical Trial
Public title
Effect of Frenkel Exercises in aged patients with balance disorders
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 65 years Having a confidential family caregiver between 18 and 60 years old According to the results of the Romberg test, have balance problems Having independence based on the KATZ Basic ADL questionnaire (a person enters the study with a score of 5 or 6
Exclusion criteria:
Cognitive impairment based on the MMSE questionnaire, a person with a score of 18 and above is included in the study Regularly or irregularly used exercise for balance during the last six months Existence of medical contraindications to exercise, such as chest pain, shortness of breath, extreme fatigue, severe muscle and joint pain, disability, heart beat and deformity The presence of destructive progressive neurological disorders such as dementia and Parkinson's that interfere with the ability to exercise
Age
From 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the randomization software, the elderly will be grouped in blocks of 4 and will be placed in two groups A and B, and then the letter A will be randomly assigned to the intervention group and the letter B will be assigned to the control group. The required sequence for allocating patients to 2 groups (intervention group and control group) will be done through randomization and based on the generation of numbers through the software (randomizer). The order of randomization will be done in secret, that is, 82 envelopes will be prepared in the package, in each of which there will be code A and B. After it is determined that the target person participates in the study, the researcher takes the target envelope in the specified order and takes action based on the group registered in the envelope.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences, 7th Blvd, Shahroud
City
Shahroud
Province
Semnan
Postal code
3614773943
Approval date
2022-12-10, 1401/09/19
Ethics committee reference number
IR.SHMU.REC.1401.183

Health conditions studied

1

Description of health condition studied
Balance disorder
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The score of Fear of fall in Falls Efficacy Scale-International
Timepoint
Measuring the fear of falling at the beginning of the study (before the intervention) and at the end of the study (the day after the last training session)
Method of measurement
Falls Efficacy Scale-International

2

Description
The score of gait disorder in Timed Up and Go test
Timepoint
Measurement of walking disorder at the beginning of the study (before the start of the intervention) and at the end of the study (the day after the last training session)
Method of measurement
Timed Up and Go test

Secondary outcomes

1

Description
Changes in personal medication use
Timepoint
at the beginning of the study (before the start of the intervention) and at the end of the study (one day after the last training session)
Method of measurement
Personal characteristics questinnaire

Intervention groups

1

Description
Intervention group: Frankel's balance exercises are used, which include learning how to walk with the upper limbs and learning how to turn, sit and stand up using various everyday objects such as a chair, a bed or painted footprints on the floor.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Tasua super special clinic
Full name of responsible person
Mohammad reza vesgar
Street address
In front of Imam Hassan Mosque, Shahid Bazzaz Ave
City
Babol
Province
Mazandaran
Postal code
4717665764
Phone
+98 11 3237 4267
Email
hamedsalahi7697@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr.Mohammad Hasan Emamian
Street address
Shahroud university of medical sciences, 7th Tir Blvd, Shahroud Town
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۳
Phone
+98 23 3239 5054
Email
info@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Hamed Salahi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 14, Psdaran 2 Ave, Karegar Blvd, Bahre Eram Town
City
Babol
Province
Mazandaran
Postal code
4717665764
Phone
+98 11 3219 9699
Email
hamedsalahi7697@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Hamed Salahi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 14, Pasdaran 2T Karegar Blvd, Bahre Eram Town
City
Babol
Province
Mazandaran
Postal code
4717665764
Phone
+98 11 3219 9699
Email
hamedsalahi7697@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Hamed Salahi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 14, Pasdaran 2, Karegar Blvd, Bahre Eram Town
City
Babol
Province
Mazandaran
Postal code
4717665764
Phone
+98 11 3219 9699
Email
hamedsalahi7697@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Release as thesis
When the data will become available and for how long
Six months after defending the thesis
To whom data/document is available
Researchers working in academic and scientific institutions, people working in industry
Under which criteria data/document could be used
It will be accessible by submitting an application to the university
From where data/document is obtainable
Hamed Salahi, project manager
What processes are involved for a request to access data/document
Submit their request via email
Comments
Loading...