Protocol summary

Summary
The purpose of this study was to survey the effect of Cawthorne and Cooksey exercises on quality of life and balance of 60 to 80 year old people. The research sample consisted of forty elderly people residing in Shiraz which were attended to Shiraz Jahandidegan retirement center. Sample size calculation was based on sample size used in previous studies. Forty selected people randomly put in two interventions (20) and control (20) groups. People who were participated in this study must obtain a minimum score of 18 out of 30 in the Mini Mental State Examination (MMSE) and not have any problem in cognition , vision and hearing which can not be corrected also they must not have pathologic diagnosis such as Neuromusculoskeletal disease, Orthopedic, Neurologic , Rheumatologic, Psychologic, Cardio vascular and uncontrolled Hypertension in the past 3 years. Exclusion criteria were considered as patients' unwillingness to continue for cooperation, in the incidence of diseases such as stroke, etc. during the study. The balance and individual’s life quality with using Berg balance scale questionnaire and 36 Short Form survey (SF-36) quality of life questionnaire in two steps (before and after 2 months intervention) were calculated. The intervention group for 2 months and 3 days a week, 60 minutes for each session conducted Cawthorne and Cooksey exercises. Cawthorne and cooksey exercise protocol is one of the most common vestibular Rehabilitation program that involve balance centers such as vision, proprioception and vestibular and can be used to promote new peripheral sensorial information arrangements.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014061618111N1
Registration date: 2016-05-18, 1395/02/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-05-18, 1395/02/29
Registrant information
Name
Abolghasem Fallahzadehabarghuei
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71386271551
Email address
fallahzadehm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Shiraz University of Medical Sciences
Expected recruitment start date
2013-11-16, 1392/08/25
Expected recruitment end date
2013-12-16, 1392/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Cawthorne and Cooksey exercises on quality of life and balance of 60 to 80 year old people in the intervention group with control group who are not receiving this exercises
Public title
The effect of Cawthorne and Cooksey exercises on quality of life and balance of 60 to 80 year old
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: No cognitive; visual; uncorrectable hearing problems; not having neuromuscular; orthopedic; neurologic; rheumatologic; psychological; cardiovascular diseases and uncontrolled blood pressure (during the last three years) and non-use of nerves medicines specific for chronic mental illness; anti epileptic drugs or other nerves medicines and tranquilizer with high dosage and obtaining a minimum score of 18 out of 30 in the Mini Mental Status Examination. Exclusion criteria were considered as patients' unwillingness to continue for cooperation; in the incidence of diseases such as stroke; etc during the study.
Age
From 59 years old to 79 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
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
Ethics Committee of Shiraz University of Medical Sciences
Street address
in front of the palestine Street, Zand Street.
City
Shiraz
Postal code
14336_71348
Approval date
2013-04-10, 1392/01/21
Ethics committee reference number
CT-P-9361-6731

Health conditions studied

1

Description of health condition studied
Balance and Quality Of Life in elderly
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Balance
Timepoint
Before intervention, 1 month after beginning of intervention, at the end of the intervention
Method of measurement
Berg Balance Scale

2

Description
Quality Of Life
Timepoint
Before intervention, 1 month after beginning of intervention, at the end of the intervention
Method of measurement
SF36 Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group conducted Cawthorne and Cooksey exercises for 2 months, 3 days a week for 60 minutes each session. The duration of doing exercises was based on previous studies. Cawthorne and Cooksey exercises are part of vestibular rehabilitation program and involve head, neck and eye movements, postural control exercises in different positions (seated, in two- leg and one-leg positions, walking), use of soft surface to reduce proprioceptive input, and exercises with closed eyes to exclude visual cues.
Category
Rehabilitation

2

Description
the control group did not receive any intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
daily center of Jahandidegan Retirement center
Full name of responsible person
Mr Shafiee
Street address
Kholdebarin Park, Besat blvd., Shiraz
City
Shiraz

2

Recruitment center
Name of recruitment center
Daily center of Retired Older Adults
Full name of responsible person
Abolghasem Fallahzadeh
Street address
School of Rehabilitation, Shiraz University of Medical Sciences
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Doctor Basir Hashemi
Street address
Vice chancellor for research, Shiraz university of medical Sciences, Zand Street.
City
Shiraz
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, Shiraz 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
School of Rehabilitation, Shiraz University of medical sciences Sciences
Full name of responsible person
Ali Ghanbary
Position
PhD of Physical Therapy / Faculty Research Assistant
Other areas of specialty/work
Street address
Abiverdi Street, Chamran Blvd
City
Shiraz
Postal code
71345_1733
Phone
00987136261551_2
Fax
Email
ghanbary@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Rehabilitation,Shiraz University of Medical Sciencess Sciences
Full name of responsible person
Abolghasem Fallahzadeh
Position
Master Of Science
Other areas of specialty/work
Street address
Abiverdi St, Chamran Blvd.
City
Shiraz
Postal code
71345_1733
Phone
+98 713271551
Fax
Email
fallahzadehm@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of rehabilitation,Shiraz University Of Medical Science
Full name of responsible person
Abolghasem Fallahzadeh
Position
Master of Science / Faculty member
Other areas of specialty/work
Street address
Abiverdi St. Chamran Blvd.
City
Shiraz
Postal code
Phone
+98 71 3327 1551
Fax
Email
fallahzadehm@sums.ac.ir
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...