Protocol summary

Summary
The effects of Hayateno rehabilitation center multidisciplinary protocol on Multiple sclerosis patent's quality of life Introduction: Multiple sclerosis is a progressive demyelization disease that leaves many patients with disability. Multidisciplinary neurorehabilitation is an effective treatment for quality of life improvement in MS patients. The goal of this study is to show the effect of Hayateno center rehabilitation protocol on quality of life of MS patients. Method and Material: 130 MS patients (65 patients in the intervention and 65 in the control group) were divided into two groups (non-random). The two groups were matched according to sex, age, education, type of MS , marriage, MS disease onset time and disability status. Information was gathered via a three parts questionnaire including demographic information form, Farsi version of MSQOL-54 questionnaire, and Farsi version of PDDS questionnaire. After 3 month and at least doing 8 sessions (mean = 18 sessions) of Hayateno multidisciplinary neurorehabilitation protocol, the questionnaire was filled for both groups and their MSQOL-54 result and the changes in quality of life were compared using SPSS software.

General information

Acronym
MS
IRCT registration information
IRCT registration number: IRCT138904284414N1
Registration date: 2010-10-21, 1389/07/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-10-21, 1389/07/29
Registrant information
Name
Farnoosh Rashvand
Name of organization / entity
Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 912 118 3026
Email address
f.rashvand@iua_abhar.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2003-08-23, 1382/06/01
Expected recruitment end date
2004-04-16, 1383/01/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Hayateno rehabilitation center multidisciplinary protocol on Multiple sclerosis patient's quality of life
Public title
The effects of Hayateno rehabilitation center multidisciplinary protocol on Multiple sclerosis patient's quality of life
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: patients must have proven MS and they should not have any attack during the last three months. Exclusion criteria: If they do not follow their protocol correctly and sufficiently and If they have new attack.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 130
Randomization (investigator's opinion)
Not 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
University of Welfare and Rehablitation Science
Street address
Koodakyar st, Daneshjoo Blvd, Evin,Tehran
City
Tehran
Postal code
1985713834
Approval date
2010-08-24, 1389/06/02
Ethics committee reference number
801/4/89/1120

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
quality of life in multiple sclerosis patients
Timepoint
3 month
Method of measurement
Multiple sclerosis quality of life 54 (MSQOL-54)

Secondary outcomes

1

Description
The Patient Determined Disease Steps (PDDS) in multiple sclerosis patients
Timepoint
3 month
Method of measurement
The Patient Determined Disease Steps(PDDS)

Intervention groups

1

Description
Intervention group: exercise therapy, Physiotherapy,familial and psychological consulting , occupational therapy and speech therapy were our intervention .
Category
Rehabilitation

2

Description
Control group: no intervention
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Hayateno physiotherapy clinic
Full name of responsible person
Bahram Sangelaji
Street address
Number35, Shams st , Vesal Ave
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iranian MS society
Full name of responsible person
bahram sangelaji
Street address
Number 35 , Shams st , Vesal Ave
City
Tehran
Grant name
بهرام سنگلجي
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian MS society
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
Iranian MS society
Full name of responsible person
Farnoosh Rashvand
Position
faculty member of Abhar Islamic Azad Univarsity
Other areas of specialty/work
Street address
Number 35 , Shams st , Vesal Ave
City
Tehran
Postal code
Iran
Phone
+98 21 6695 9481
Fax
+98 21 6649 9514
Email
f.rashvand@iua_abhar.ac.ir ; bsangelaji@mshayateno.com
Web page address
www.mshayateno.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iranian MS society
Full name of responsible person
Bahram Sangelaji
Position
Master of sciense
Other areas of specialty/work
Street address
Number 35, Shams st , Vesal Ave
City
Tehran
Postal code
Iran
Phone
+98 21 6695 9481
Fax
+98 21 6649 9514
Email
f.rashvand@iua_abhar.ac.ir ; bsangelaji@mshayateno.com
Web page address
www.mshayateno.com

Person responsible for updating data

Contact
Name of organization / entity
Iranian MS society
Full name of responsible person
Farnoosh Rashvand
Position
Master of science faculty member of Abhar Islamic Azad University
Other areas of specialty/work
Street address
Number35, Shams st , Vesal Ave
City
Tehran
Postal code
34148_33839
Phone
+98 21 6695 9480
Fax
+98 21 6649 9514
Email
f.rashvand@iua_abhar.ac.ir
Web page address
www.hayateno.com

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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