The effect of hip joint mobilization with movement on muscle activity pattern, postural control and static and dynamic balance in patients with chronic stroke: Randomized clinical trial
-Determining the pattern of muscle activity, postural stability, dynamic and functional balance before, after and two weeks after treatment in each group and between groups
Design
This clinical trial contains: a control group, parallel group trial, double blinded, pilot study, permuted block randomization with a block size of 4
Settings and conduct
After screening, the patients with hemiplegia following stroke will sign the informed consent.The patients will be randomly allocated to the experimental (hip joint mobilization with movement) and the control group (conventional physiotherapy). Assessments and statistical analysis will performed by blinded physiotherapist and statistician, respectively.
Participants/Inclusion and exclusion criteria
-Hemiplegia secondary to stroke; -stroke onset >6 months; -The ability to stand and walk independently;
Exclusion criteria:
-Any orthopedic and neurological disease affecting balance control; -Contraindications for hip joint mobilization and superficial electromyography;
Intervention groups
Intervention group: hip joint mobilization with movement in addition to the conventional physiotherapy
Control group: conventional physiotherapy
Main outcome variables
Postural stability; dynamic balance; functional balance and muscle activity pattern
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200613047759N1
Registration date:2020-08-02, 1399/05/12
Registration timing:registered_while_recruiting
Last update:2020-08-02, 1399/05/12
Update count:0
Registration date
2020-08-02, 1399/05/12
Registrant information
Name
soudeh arabzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 1552
Email address
s_arabzadeh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hip joint mobilization with movement on muscle activity pattern, postural control and static and dynamic balance in patients with chronic stroke: Randomized clinical trial
Public title
The effect of hip joint mobilization with movement on muscle activity, and balance in patients with chronic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
-The presence of hemiplegia secondary to stroke -History of stroke onset >6 months and a maximum of 1 year prior to the study -The ability to stand and walk independently without the use of assist-devices -Mini-Mental State Examination score of >24 -Within stages 2–4 of Brünnstrom -The age range of 35-65 years old -The ability to follow verbal commands
Exclusion criteria:
-Any orthopedic disease affecting balance control -Any neurological condition affecting balance control -Taking any medication that causes peripheral neuropathy -Have a visual impairment -Have a hearing impairment -Have a history of spinal disorders affecting gait and lower limb function -There is a cerebellar stroke at the same time -Contraindications for hip joint mobilization -Contraindications on the use of superficial electromyography
Age
From 35 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization with a block size of 4 will be done with statistical software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are unaware of whether they are in the control or experimental group. Also all outcome will be measured and analyzed by an experienced physical therapist and statistician, who was blinded to the grouping. Also, in order to blind the participants, the treatment of each group will be done on different days of the week.
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
Second Floor, No. 18, Niloufar Alley, Hasht Behesht Sharghi St.
City
Isfahan
Province
Isfehan
Postal code
8157686811
Approval date
2020-06-09, 1399/03/20
Ethics committee reference number
IR.SUMS.REHAB.REC.1399.019
Health conditions studied
1
Description of health condition studied
Chronic stroke
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Postural stability
Timepoint
1 day before intervention, 1 day after intervention and 14 days after intervention
Method of measurement
Biodex balance system
2
Description
Dynamic balance
Timepoint
1 day before intervention, 1 day after intervention and 14 days after
Method of measurement
Time Up and Go test
3
Description
Functional balance
Timepoint
1 day before intervention, 1 day after intervention and 14 days after
Method of measurement
Berg Balance Scale
Secondary outcomes
1
Description
Muscle activity pattern
Timepoint
1 day before intervention, 1 day after intervention and 14 days after intervention
Method of measurement
Surface electromyography
Intervention groups
1
Description
Experimental group: hip joint mobilization with movement technique for three times per week for 4 weeks, a grade III glide will be sustained for 10 seconds and relaxed for 5 seconds over 3 sets of 6 repetitions with a 1- minute rest between sets after receiving 30 minutes of conventional physiotherapy
Category
Rehabilitation
2
Description
Control group: 30 minutes of conventional physical therapy, 3 times a week for 4 weeks as follows: the first 10 minutes of the active and passive range of motion exercises for the lower limb of the affected side; the next 10 min for Weigh Bearing training during sitting and standing; and the final 10 min for walking.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of School of Rehabilitation Sciences
Full name of responsible person
Mohsen Razeghi
Street address
Clinic of Shiraz Faculty of Rehabilitation Sciences Clinic, Abiverdi 1 Alley, Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
۷۱۹۴۷۳۳۶۶۹
Phone
+98 71 3627 1552
Fax
+98 71 3627 2495
Email
Rehab@Sums.ac.ir
Web page address
https://rehab.sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Yunes Ghasemi
Street address
Deputy of Research and Technology, 7th Floor, Central Building of Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Province
Fars
Postal code
۷۱۹۴۷۳۳۶۶۹
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
ghasemiy@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Soudeh Arabzadeh
Position
PhD candidate in physiotherapy
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No.18, Niloufar Alley, Hasht Behesht Sharghi St.
City
Isfahan
Province
Isfehan
Postal code
8157686811
Phone
009831665568
Email
s_arabzadeh@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Soudeh Arabzadeh
Position
PhD candidate in Physiotherapy
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No.18, Niloufar Alley, Hasht Behesht Sharghi St.
City
Isfahan
Province
Isfehan
Postal code
8157686811
Phone
009831665568
Email
s_arabzadeh@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Soudeh Arabzadeh
Position
PhD candidate in Physiotherapy
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No.18, Niloufar Alley, Hasht Behesht Sharghi St.
City
Isfahan
Province
Isfehan
Postal code
8157686811
Phone
009831665568
Email
s_arabzadeh@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
After coordination with the Research Ethics Committee for approval of the ethics committee, participants data file will be provided In complete secrecy and for research purposes only.
When the data will become available and for how long
After acceptance of the article by the journal
To whom data/document is available
In addition to the principal researcher and the supervisor of the project, upon request, access to information can be reviewed by the Ethics Committee.
Under which criteria data/document could be used
Preferably it is only used for the subject of my research, but if research is to be done in order to use the statistical population, the main project executor and the student's main collaborator will make a decision with the permission of the ethics committee.
From where data/document is obtainable
Executors of the project can first be referred to through Dr. Fahimeh Kamali Sarvestani (09177110341), secondly through Dr. Mohsen Razaghi (09173130718) and the main colleague and student collaborator Ms Soudeh Arabzadeh (09369332615).
What processes are involved for a request to access data/document
6 months after the article was published, referring the request to the executor of the project, in addition, an official letter from the ethics committee will be commented on in order to obtain a license, and if the ethics committee approves, emphasizing the confidentiality of the information, the requested information will be provided to the applicant.