Protocol summary

Study aim
Evaluation of the effect of a walking period with the instructions of the external focus on balance, gait and verbal memory of the blind
Design
A two-group clinical trial, including a 9-person control group and an experimental 9-person group, one-way blind, was performed by simple random sampling on 18 blind people.
Settings and conduct
In the pre-test stage, Wexler static balance, dynamic balance, walking and expansive memory tests were taken. To perform static and dynamic balance test, foot scan device was used to record the pressure center and motion step analysis device was used to take steps.. The Wechsler Width Memory Test was also used to measure participants' short-term memory. Then, 9 people in the experimental group practiced walking for six weeks, three sessions per week and 20 minutes each session along with the instructions of the external focus, and the control group did not follow the purposeful training during this period. All statistical calculations were performed in SPSS software version 21 at a significant level (P = 0.05). measurements were performed at the Health Center of Mazandaran University.
Participants/Inclusion and exclusion criteria
Age 12 to 16 years, hearing impairment, no history of limb failure in the past year, no other Cognitive developmental disorders and lack of information other mental and physical
Intervention groups
1.The control group: 9 blind people without intervention during the study. 2.The experimental group: 9 blind people who intervened during the research
Main outcome variables
There was no significant difference between the mean of the center of pressure (P=0.0629), a distance of the center of pressure (P=0.613), and the range of pressure center in the external internal path (P=0.428) and posterior-anterior path (P=0.063). Whereas this exercise period had a significant effect on the verbal memory of the blind (P=0.035).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201013049014N1
Registration date: 2020-11-01, 1399/08/11
Registration timing: retrospective

Last update: 2020-11-01, 1399/08/11
Update count: 0
Registration date
2020-11-01, 1399/08/11
Registrant information
Name
Fahimeh Hasanzade
Name of organization / entity
The University of Semnan
Country
Iran (Islamic Republic of)
Phone
+98 11 4207 6756
Email address
fahimhz15@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-11, 1398/08/20
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
2019-11-11, 1398/08/20
Actual recruitment end date
2019-11-21, 1398/08/30
Trial completion date
2020-01-10, 1398/10/20
Scientific title
The Effect of a Walking Course with the Focus of External Attention on the Balance, Gait and Verbal Memory of Blinds
Public title
The Effect of a Walking Course with the Focus of External Attention on the Balance, Gait and Verbal Memory of Blinds
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Blind
Exclusion criteria:
Age
From 12 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 20
Actual sample size reached: 18
Randomization (investigator's opinion)
Randomized
Randomization description
First, participants in the study were categorized by gender and age. Each age group (12, 13, 14, 16, 15 years old girls and boys) was given a code in each gender and then the codes were randomly assigned to the control and experimental groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants in the study were blind people who were kept in daycare centers and entered the study voluntarily by completing the consent form. Subjects were randomly divided into experimental and control groups. The experimental group was told that they would participate in a training session to stay healthy, but they did not know the purpose of the exercises, which was to improve balance performance. However, at the end of the exercises and research, they were given an explanation about the results of the exercises, including changes in balance.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Mazandaran University
Street address
Mazandaran, Babolsar, University of Mazandaran
City
Babolsar
Province
Mazandaran
Postal code
۱۳۵۳۴-۴۷۴۱۶
Approval date
2020-09-15, 1399/06/25
Ethics committee reference number
IR.Umz.REC.1399.008

Health conditions studied

1

Description of health condition studied
Blindness
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Static balance
Timepoint
At the beginning of the study (before the intervention) and 6 weeks after the interventions
Method of measurement
Foot scan

2

Description
Dynamic balance
Timepoint
At the beginning of the study (before the intervention) and 6 weeks after the interventions
Method of measurement
Foot scan

3

Description
Verbal memory and parrot-like memory assessment
Timepoint
At the beginning of the study (before the intervention) and 6 weeks after the interventions
Method of measurement
Wechsler's Memory

4

Description
Gait
Timepoint
At the beginning of the study (before the intervention) and 6 weeks after the interventions
Method of measurement
motion analysis

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The experimental group performed walking exercises with using headphones and provided rhythmic auditory pulses for 6 weeks, three days a week for each session in the presence of a guide.
Category
Behavior

2

Description
Control group: The experimental group did not perform any exercises.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Haj Naser Mahdavi School
Full name of responsible person
Akram Aghagolzade
Street address
Qaemshahr-Babol road, in front of Telar Hotel, at the beginning of the military road
City
Qaemshahr
Province
Mazandaran
Postal code
۱۴۱۶۹۳۵۶۸۴
Phone
+98 11 4229 4031
Email
Nkh.rama@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Semnan
Full name of responsible person
Mojgan Memarmoghadam
Street address
In front of Sokan Park - Campus No. 1 - Central Organization of Semnan University
City
Semnan
Province
Semnan
Postal code
19111-35131
Phone
+98 23 3153 0000
Email
mmemarmoghaddam@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Semnan
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
The University of Mazandaran
Full name of responsible person
Mojggan Memarmoghaddam
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
PhD / Motor Behavior
Street address
Mazandaran University - Faculty of Sports Sciences
City
Babolsar
Province
Mazandaran
Postal code
1353447416
Phone
0113530
Email
mmemarmoghaddam@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Mazandaran
Full name of responsible person
Mozhgan Memarmoghaddam
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
PhD / Motor Behavior
Street address
Mazandaran University - Faculty of Sports Sciences
City
Babolsar
Province
Mazandaran
Postal code
1353447416
Phone
0113530
Email
mmemarmoghaddam@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Semnan
Full name of responsible person
Fahimeh Hasanzade
Position
University student
Latest degree
Master
Other areas of specialty/work
Motor Behavior-Motor Development
Street address
Kh. Sari- Kh. Moulavi- Kouche Erfan 1.
City
Qaemshahr
Province
Mazandaran
Postal code
4764717498
Phone
+98 11 4207 6756
Email
Www.fahimhz15@yahoo.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
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