History
# Registration date Revision Id
2 2023-04-12, 1402/01/23 264220
1 2015-12-30, 1394/10/09 21274
Changes made to previous revision
This is the first revision

Protocol summary

Summary
Objectives: to assess the effect of hydrotherapy program on balance in patients with Parkinson's disease Design: semi-experimental pretest-posttest with control group Setting and Conduct: 36 men patients with Parkinson's were selected and voluntarily entered in two groups of experimental (n=20) and control (n =16). Major inclusion and exclusion criteria: patients consent for volunteer participation in the study, patients who were diagnosed of mild to moderate stages (I- III) by neurologist, willingness and ability to exercise, lack of muscular-skeletal problems, lack of maim, lack of cardiovascular or serious diseases and no involvement in any exercise activity or physiotherapy treatments. Exclusion criteria: inability to perform hydrotherapy, being in advanced stages of the disease (IV&V) according to Hoehn & Yahr scale. Interventions: experimental group, for 12 weeks took part in 3 sessions (each 60 minutes) of hydrotherapy, as well as taking medications. The control group only took medications, receiving no regular exercise program. Main outcome measures: balance

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015120825436N1
Registration date: 2015-12-30, 1394/10/09
Registration timing: retrospective

Last update:
Update count: 1
Registration date
2015-12-30, 1394/10/09
Registrant information
Name
Hakimeh Baziyar
Name of organization / entity
-
Country
Iran (Islamic Republic of)
Phone
+98 38 3422 7674
Email address
hakimehbaziyar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Isfahan University
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial the effect of hydrotherapy on balance in patients with Parkinson's disease
Public title
The effect of hydrotherapy in treatment of Parkinson's disease
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: patients consent for volunteer participation in the study, patients who were diagnosed of mild to moderate stages (I- III) by neurologist, willingness and ability to exercise, lack of muscular-skeletal problems, lack of maim, lack of cardiovascular or serious diseases and no involvement in any exercise activity or physiotherapy treatments. Exclusion criteria: inability to perform hydrotherapy, being in advanced stages of the disease (IV&V) according Hoehn & Yahr scale.
Age
No age limit
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 36
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

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University
Street address
Isfahan University, Hezaar Jerib Street, Isfahan
City
Isfahan
Postal code
Approval date
2013-01-18, 1391/10/29
Ethics committee reference number
-

Health conditions studied

1

Description of health condition studied
Parkinson's disease
ICD-10 code
G30, G31,
ICD-10 code description
Other degenerative diseases of the nervous system

Primary outcomes

1

Description
balance
Timepoint
before intervention-three months after the intervention
Method of measurement
Berg Balance Scale

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
Intervention group: for 12 weeks took part in 3 sessions (each 60 minutes) of hydrotherapy, as well as taking medication
Category
Rehabilitation

2

Description
Control group: medication
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr Ahmad Chitsaz
Street address
Alzahra Hospital, Sofeh Boulevard, Shahid Keshvari Highway, Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Isfahan University
Full name of responsible person
Dr Mehdi Kargarfard
Street address
Faculty of Physical Education, Isfahan University
City
Isfahan
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Isfahan University
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
-
Full name of responsible person
Hakimeh Baziyar
Position
MS of Exercise Physiology
Other areas of specialty/work
Street address
No. 17, 27 Street, Bouali Boulevard, Borujen
City
Borujen
Postal code
Phone
+98 38 3422 7674
Fax
Email
Hakimehbaziyar@yahoo.com; Hakimehbaziyar@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
-
Full name of responsible person
Hakimeh Baziyar
Position
Ms of Exercise Physiology
Other areas of specialty/work
Street address
No. 17, 27 Street, Bouali Boulevard, Borujen
City
Borujen
Postal code
Phone
+98 913 979 4823
Fax
Email
Hakimehbaziyar@yahoo.com; Hakimehbaziyar@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Hakimeh Baziyar
Position
Ms of exercise physiology
Other areas of specialty/work
Street address
City
Boroojen
Postal code
Phone
+98 38 3422 7674
Fax
Email
Hakimehbaziyar@yahoo.com; Hakimehbaziyar@gmail.com
Web page address

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
Loading...