Our aim in this study is to evaluate the efficacy of hippotherapy on stability in patients with multiple sclerosis. In a unicentral clinical trial 30 patients with multiple sclerosis from both genders referring to the physiotherapy clinic of Emam Reza hospital, Tabriz, Iran, would be involved. The key inclusion criteria are to be 18 years old or older; to have the ability to stand upright for at least 1 minute and the key exclusion criteria are MS patients who have undergone an amputation; MS patients with CVA or Diabetes. Falling risk and postural stability using a specific set would be measured before starting the hippotherapy (Baseline) and each 4 weeks for all the individuals. The treatment would be continued for 12 weeks for 3 sessions in a week and each session for half an hour. The treatment will be continued for 16 weeks if we find out that the treatment outcome is not as well as what we expected. Outcome measures would include Berg Balance Scale, Disability Score, Falling Risk and Postural stability. Gathered data for pre and post treatment measures will be compared to draw a conclusion.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206102664N2
Registration date:2012-06-13, 1391/03/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-06-13, 1391/03/24
Registrant information
Name
Yaghoub Salekzamani
Name of organization / entity
Tabriz University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 3967
Email address
salekzamaniy@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-03-18, 1390/12/28
Expected recruitment end date
2012-12-18, 1391/09/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of hippotherapy on stability in patients with multiple sclerosis
Public title
Proposing a new method in treatment of patients with Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (to be 18 years old or older; to have the ability to stand upright for at least 1 minute; not to have a history of prior orthopedic or other non-MS-associated conditions; not to have a history of prior hippotherapy)
Exclusion criteria: (MS patients who have undergone an amputation; MS patients with CVA or Diabetes)
Age
From 18 years old to 149 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah Square
City
Tabriz
Postal code
Approval date
2012-03-12, 1390/12/22
Ethics committee reference number
9022
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Disability Score
Timepoint
Before starting hippotherapy and then each 4 weeks for 12 weeks
Method of measurement
Using a check list
2
Description
Berg Balance Scale
Timepoint
Before starting hippotherapy and then each 4 weeks for 12 weeks
Method of measurement
Using a check list
3
Description
Falling Risk
Timepoint
Before starting hippotherapy and then each 4 weeks for 12 weeks
Method of measurement
Using a specific set
4
Description
Postural Stability
Timepoint
Before starting hippotherapy and then each 4 weeks for 12 weeks
Method of measurement
Using a specific set
Secondary outcomes
empty
Intervention groups
1
Description
The treatment for all the ptients would be continued for 12 weeks for 3 sessions in a week and each session for half an hour. The treatment will be continued for 16 weeks if we find out that the treatment outcome is not as well as what we expected.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy clinic of Emam Reza hospital
Full name of responsible person
Said Siahi
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostad Rahimi
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah square
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Said Siahi
Position
Physiotherapy resident
Other areas of specialty/work
Street address
Physiotherapy ward, Emam Reza hospital
City
Tabriz
Postal code
Phone
+98 41 1658 4153
Fax
Email
dr.saidsiahi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Yaghoub Salek Zamani
Position
Assistant professor/ Physiatrist
Other areas of specialty/work
Street address
Physiotherapy ward of Emam Reza hospital
City
Tabriz
Postal code
Phone
+98 41 1337 3967
Fax
Email
ysz48@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Said Siahi
Position
Physiotherapy resident
Other areas of specialty/work
Street address
Physiotherapy ward of Emam Reza hospital
City
Tabriz
Postal code
Phone
+98 41 1658 4153
Fax
Email
dr.saidsiahi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)