Objective: Comparison the effects of Cooksey - Cawthorne and Frenkel exercises on balance and fatigue dimensions in patients with multiple sclerosis. The study population: consist of multiple sclerosis patients who have had recorded accounts in Vice-Chancellor in treatment affairs of Yasuj University of Medical Sciences. Inclusion and exclusion criteria: Inclusion criteria include diagnosis of multiple sclerosis by a physician; receive mark 21-40 in berg balance scale and receive mark 54-106 in fatigue impact scale; having at least literacy and having at least conditions for participate to study. Exclusion criteria included relapses during the intervention. Sample size: 25 patients in Cooksey-Cawthorne exercise group (group 1), 25 patients in Frenkel exercise group (Group 2) and 25 patients in control groups (Group 3) were allocated. In Group 1 Cooksey-Cawthorne exercise program presented as a group to research units and they will be asked during an 3-months, three times a week and 45 minutes per session to do exercise that includes eye and head movements in sitting position which must be done at first slowly and then faster; movements of the head and trunk in sitting position and standing exercises. In Group 2, Frenkel exercise program presented as a group to research units and they will be asked during an 3-months, three times a week and 45 minutes per session to do exercise in a state of supine, sitting and standing. In Group 3, control group receive no specific intervention. Primary outcomes: body balance, fatigue dimensions and fatigue severity.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016031527063N1
Registration date:2016-05-12, 1395/02/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-12, 1395/02/23
Registrant information
Name
Fatemeh Karami
Name of organization / entity
Yasuj Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 5141
Email address
karami.fatemeh@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Yasuj University of Medical Sciences
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2016-06-04, 1395/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of Cooksey - Cawthorne and Frenkel exercises on balance and fatigue dimensions in patients with multiple sclerosis
Public title
Effects of rehabilitation interventions on balance and fatigue in MS patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of multiple sclerosis by a physician, at least in the last 6 months; being patient in remission period; ability to stand without assistance for 30 seconds and walk without help an area of 6 m; receive mark 21-40 in berg balance scale; receive mark less than 5/5 in degree of disability and diagnosis by doctor; receive informed consent of patient and if necessary legal guardian; patient willingness to participate in the study; no participate in the same study; not doing sports activities in the last 6 months; no risk of acute or chronic disease other than multiple sclerosis and receive mark 54-106 in fatigue impact scale. Exclusion criteria: lack of patient motivation to continue working; relapses during the intervention; having tired too so that the patient is not able to do the exercises; migration and death.
Age
From 15 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Seventy-five patients with multiple sclerosis by blocking will be divided into three groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Research Management of Yasuj University of Medical Sciences, Research and Technology Deputy of Yasuj University of Medical Sciences, Shahid Motahary Blvd., Yasuj, Iran
City
Yasuj
Postal code
Approval date
2016-03-14, 1394/12/24
Ethics committee reference number
IR.YUMS.REC.1394.180
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
Body balance
Timepoint
Before the intervention, a month and a half after the intervention and after intervention
Method of measurement
Berg balance scale
2
Description
Fatigue Dimensions
Timepoint
Before the intervention, a month and a half after the intervention and after intervention
Method of measurement
Fatigue Impact Scale
3
Description
Fatigue Severity
Timepoint
Before the intervention, a month and a half after the intervention and after intervention
Method of measurement
Exclusive Fatigue Severity Scale for multiple sclerosis patients
Secondary outcomes
empty
Intervention groups
1
Description
In Group 1 Cooksey-Cawthorne exercise program presented as a group to research units and they will be asked during an 3-months, three times a week and 45 minutes per session to do exercise that includes eye and head movements in sitting position which must be done at first slowly and then faster; movements of the head and trunk in sitting position and standing exercises.
Category
Rehabilitation
2
Description
In Group 2, Frenkel exercise program presented as a group to research units and they will be asked during an 3-months, three times a week and 45 minutes per session to do exercise in a state of supine, sitting and standing.
Category
Rehabilitation
3
Description
In Group 3, control group receive no specific intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Office of an assisstant of treatment of Yasuj University of Medical Science
Full name of responsible person
Dr Ardashir Afrasiabifar
Street address
Nursing and Midwifery College, Shahid Dr. Jalil St., Yasuj, Iran
City
Yasuj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Yasuj University of Medical Sciences
Full name of responsible person
Dr. Mehdi Akbartabar Tori
Street address
Research Management of Yasuj University of Medical Sciences, Research and Technology Deputy of Yasuj University of Medical Sciences, Shahid Motahary Blvd., Yasuj, Iran
City
Yasuj
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, Yasuj 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
Yasuj University of Medical Sciences
Full name of responsible person
Dr Ardeshir Afrasiabifar
Position
Ph.D of Medical Surgical Nursing- Associate Professor
Other areas of specialty/work
Street address
Nursing and Midwifery College, Shahid Dr. Jalil St., Yasuj, Iran
City
Yasuj
Postal code
Phone
+98 74 3323 5141
Fax
+98 74 1223 4115
Email
afrasiabifar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasuj University of Medical Science
Full name of responsible person
Dr Ardeshir Afrasiabifar
Position
Ph.D of Medical Surgical Nursing- Associate Professor
Other areas of specialty/work
Street address
Nursing and Midwifery College, Shahid Dr. Jalil St., Yasuj, Iran
City
Yasuj
Postal code
Phone
+98 74 3323 5141
Fax
+98 74 1333 7370
Email
afrasiabifar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yasuj Univercity of Medical Sciences
Full name of responsible person
Fatemeh Karami
Position
Master student of nursing
Other areas of specialty/work
Street address
Nursing and Midwifery College, Shahid Dr. Jalil St., Yasuj, Iran
City
Yasuj
Postal code
Phone
+98 71 5444 8162
Fax
Email
karami.fatemeh@yums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)