A Comparative Study of the Effect of Reactive and Proactive Exercises on Balance Performance and Confidence in Balance in Stroke Patients: A Randomized Clinical Trial
Comparative study of the effect of reactive and proactive exercises on balance and confidence in the balance of patients with stroke
Design
In this double-blind trial study, 33 people were randomly assigned to control and experimental groups.
Settings and conduct
This study is performed in the physiotherapy ward of Kashani Hospital in Isfahan on patients with stroke.
Participants/Inclusion and exclusion criteria
Patients (male or female) with the first history of unilateral stroke who do not have other neurological disorders and should be referred by a neurologist.
Intervention groups
All patients receive conventional evidence-based treatment for stroke rehabilitation.
The control group performs only conventional therapy and the two intervention groups, depending on the type of group, perform special balance exercises (reactive and proactive) in addition to conventional therapy.
Main outcome variables
Evaluations include assessing the degree of balance and confidence in balance in patients with stroke.The number of patient falls per week is also recorded.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200101045970N1
Registration date:2020-08-18, 1399/05/28
Registration timing:prospective
Last update:2020-08-18, 1399/05/28
Update count:0
Registration date
2020-08-18, 1399/05/28
Registrant information
Name
Ehsan Ghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3669 3089
Email address
eghasemi@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-25, 1399/06/04
Expected recruitment end date
2021-02-22, 1399/12/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative Study of the Effect of Reactive and Proactive Exercises on Balance Performance and Confidence in Balance in Stroke Patients: A Randomized Clinical Trial
Public title
The effect of exercise therapy on balance in patients with stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. A history of the first unilateral stroke proven by a neurologist with CT scan or MRI.
2. At least 6 months have passed since the onset of stroke symptoms.
3. Existence of appropriate cognitive status in order to understand simple verbal commands and follow them) According to the Persian version Mini-mental status examination ≥ 24.
4.Ability to stand and walk independently without an aid
5. Having spasticity in gastrocnemius muscle ≥1 based on Modified Modified Ashworth Scale (MMAS≥1)
6. Having a minimum age of 18 and a maximum of 85 years
Exclusion criteria:
1. The presence of other neurological disorders such as Parkinson's, diabetes,...
2. Existence of severe visual, profound and vestibular disorders
3. Existence of severe orthopedic disorders such as fixed contractures in the lower extremities
4. Severe pain in the lower extremities: According to the VAS scale, pain between 75 and 100 mm
5. Participate in other physiotherapy treatment interventions
6. Taking drugs that affect balance function (tone, sensory system and muscle strength).
7. Having a weight of more than 150 kg and a height of more than 2.1 meters
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, due to the small number of samples, it was done in consultation with a statistician decided to use random blocking method. Blocking is usually done to balance the number of samples assigned to each groups. Statistical specialist using a statistical software of 10 blocks of 3 members according that we had 3 groups, they designed.
The person who divides patients according to this table is unaware of groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients are blind to the type of treatment. Also, the evaluator that collects information is blind to the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib St., Isfahan University of Medical Sciences, Faculty of Rehabilitation
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۵۱۶۴
Approval date
2020-07-25, 1399/05/04
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.224
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Balance
Timepoint
Before study, after study, two months after study
Method of measurement
Mini BES Test
2
Description
Balance Confidence
Timepoint
Before study, after study, two months after study
Method of measurement
The Activities-specific Balance Confidence (ABC) Scale
Secondary outcomes
1
Description
Functional Mobility
Timepoint
Before study, after study, two months after study
Method of measurement
Timed Up and Go Test
2
Description
Number of falls per week
Timepoint
Before study, after study, two months after study
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: Reactive + Conventional
Category
Rehabilitation
2
Description
Intervention group: proactive + Conventional
Category
Rehabilitation
3
Description
Control group: Conventional
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Ehsan Ghasemi
Street address
Kashani street
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Fax
+98 31 3233 5030
Email
kashani@kashani.mui.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Hezar Jrib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ehsan Ghasemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Hezar Jrib Ave
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Phone
+98 31 3669 5043
Fax
+98 31 3668 7270
Email
eghasemi@rehab.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ehsan Ghasemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Hezar Jrib Ave
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Phone
+98 31 3669 5043
Email
eghasemi@rahab.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ehsan Ghasemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Hezar Jrib Ave
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Phone
+98 31 3669 5043
Email
ehasemi@rehab.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to non-plagiarism
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The study protocol and the informed consent form can be submitted as a proposal.
A clinical study report can also be provided upon completion of the work.
When the data will become available and for how long
.
The proposal is available in the fall and winter of 1399.
Access to clinical results is also possible in the summer of 1400.
To whom data/document is available
People working in academic and scientific institutions can access the documents.
Under which criteria data/document could be used
It can only be used to raise awareness and raise scientific literacy.
From where data/document is obtainable
People can correspond by email eghasemi@rehab.mui.ac.ir.
What processes are involved for a request to access data/document
After correspondence with the announced email, your request will be reviewed and answered immediately.