Protocol summary

Summary
The purpose of this research is to evaluate the effect of Hippotherapy intervention on Static Balance, Dynamic Balance, Reaction Time and Gait Cycle on Autism Spectrum Disorder. In a unicentral clinical trial, 24 male patients with Autism Spectrum Disorder referring to the Mehregan private Occupational therapy clinic,Tehran, Iran, would be involved. The key inclusion criteria are: to be 7-18 years old and having no physical disability and the key exclusion criteria are: using other activities and physical treatment methods, Cardiovascular and Respiratory diseases and Absence during the Hippotherapy session. All pre-test variables including: measuring the Static Balance with Stork test, Balance Board for Dynamic Balance evaluation, Nelson's Ruler facilitated test for measuring Reaction Time and Gait Cycle evaluation and walking on a 10-meter line to observe the sole trace and recording the time by chronometer, would be done. Afterward, they were randomly categorized into 2 groups of examination and control (n=12). The experimental group were participated in one 60-90 minute sessions of Hippotherapy for 14 successive weeks, which were intensified over time. whereas, The control group has done no specific practice during the research. Gathered data for pre and post treatment measures will be compared to draw a conclusion.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016071728966N1
Registration date: 2016-10-09, 1395/07/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-10-09, 1395/07/18
Registrant information
Name
Sara Mirzabeigi Fini
Name of organization / entity
Islamic Azad University Islamshahr Branch
Country
Iran (Islamic Republic of)
Phone
+98 21 2676 1557
Email address
sarafini@iiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of fourteen session of Hippotherapy on Balance. Reaction Time and Gait Cycle in Autism Spectrum Disorder
Public title
Hippotherapy is an innovative approach for enhancing the physical factor of people who suffer from Autism Spectrum Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:(recognition of Autism Spectrum Disorder by Physiologist and Occupational therapy and having the medical report, having no record of Epilepsy, Orthopedic, Cardiovascular, and Respiratory diseases, using no other treatment or Physical therapy or Hippotherapy; having confirmation of Psychotherapist and the family). Exclusion criteria:(Absence during the Hippotherapy session, using other treatment methods such as: Physical or Sport activities.
Age
From 7 years old to 18 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
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 in research of Islamic Azad University Tehran Medical Branch
Street address
Tehran Medical Branch , Islamic Azad UniversityT, khaghani st, shariati Ave , Tehran, Iran
City
Tehran
Postal code
1916893813
Approval date
2016-08-16, 1395/05/26
Ethics committee reference number
IR.IAU.TMU.REC.1395.124

Health conditions studied

1

Description of health condition studied
Autism Spectrum Disorder
ICD-10 code
F84.1
ICD-10 code description
A type of pervasive developmental disorder that differs from childhood autism either in age of onset or in failing to fulfil all three sets of diagnostic criteria. This subcategory should be used when there is abnormal and impaired development that is pre

Primary outcomes

1

Description
Static Balance
Timepoint
Befor staring the Hippotherapy programm and then after 14 weeks
Method of measurement
The stork test

2

Description
Dynamic Balance
Timepoint
Befor staring the Hippotherapy programm and then after 14 weeks
Method of measurement
Balance Board

3

Description
Reaction Time
Timepoint
Befor staring the Hippotherapy programm and then after 14 weeks
Method of measurement
Nelson's Ruler facilitated test

4

Description
Gait Cycle(Duration of Gait Cycle, The Number of Step, Speed of Step, Length of Step)
Timepoint
Befor staring the Hippotherapy programm and then after 14 weeks
Method of measurement
Observing the sole trace and recorded by Digital camera and chronometer

Secondary outcomes

empty

Intervention groups

1

Description
The Experimental groups were considered as one 60-90 minute sessions for 14 successive weeks of Hippotherapy program. in fact The word Hippotherapy is the usage of horses in the therapy process. The amazing communication ability of horses with human kind and the movement of horse's basin in walking which is in fact a stimulation of basin movement in human are truly effective in the recovery process of different Mental and Physical illnesses
Category
Treatment - Other

2

Description
The Control groups has not been part of any treatment or physical activities during 14 weeks of Hippotherapy session.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Mehregan Rehabilitation Clinic
Full name of responsible person
Naser Najarion
Street address
Unit 1, No. 65, Corner of Ghandahari street, West Nosrat st, Khosh street, Tohid Square
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Sara Mirzabeigi Fini
Street address
unit 3, No. 47, Bostan 6 alley, intersection of Sarv, Saadat Abad
City
Tehran
Grant name
شخصی
Grant code / Reference number
Personal
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University Islamshahr Branch
Full name of responsible person
Sara Mirzabeigi Fini
Position
Masters physical education and sport science/ member of education and research committee of equestri
Other areas of specialty/work
Street address
Islamshar, Namaz sq, Syad Shirazi st, Islamic Azad University
City
Tehran
Postal code
۳۳۱۴۷ - ۶۷۶۵۳
Phone
+98 21 5635 8105
Fax
+98 21 5635 8106
Email
info@iiau.ac.ir
Web page address
http://iiau.ac.ir/fa

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty member and Director of Masters Physical Education and Sport Science
Full name of responsible person
Yasser kazem zadeh
Position
Doctor of Sport Physiology
Other areas of specialty/work
Street address
Islamshar, Namaz sq, Syad Shirazi st, Islamic Azad University
City
Tehran
Postal code
1998995557
Phone
+98 21 5635 8105
Fax
+98 21 5635 8106
Email
http://iiau.ac.ir/fa
Web page address
http://iiau.ac.ir/fa

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University Islamshahr Branch
Full name of responsible person
Sara Mirzabeigi Fini
Position
Masters physical education and sport science/ Member of Education and Research Committee of Equestri
Other areas of specialty/work
Street address
Islamshar, Namaz sq, Syad Shirazi st, Islamic Azad University
City
Tehran
Postal code
1998995557
Phone
+98 21 5635 8105
Fax
+98 21 5635 8106
Email
info@iiau.ac.ir
Web page address
http://iiau.ac.ir/fa

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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