The purpose of this study is to determine the effect of eight-weeks corrective intervention on balance, proprioception and plantar pressure variables in woman with limited ankle dorsiflexion
Design
Clinical trial with control group, with parallel groups, single blinded, randomized
Settings and conduct
The tests will be carried out by the specialists at the Sport Rehabilitation Laboratory of Bu-Ali Sina University in Hamadan, and then interventions and exercises will take place in the gym. During the testing, the participant will be unaware of the main purpose of the research. outcome assessors and data analyzes do their job assuming all participants receive training.
Intervention group: Stretching Exercises، Exercises will be 3 sessions of 45 minutes per week for 8 weeks.
Control group: No Intervention
Participants/Inclusion and exclusion criteria
Having an active dorsiflexion angle of less than 20 degrees in sitting position, having at least 3 training sessions per week, having normal BMI (15-25)
History of any injury in the past six months, history of lower extremity surgery, ankle ligament injury
Intervention groups
Intervention group: Stretching Exercises، Exercises will be 3 sessions of 45 minutes per week for 8 weeks.
Control group: No Intervention
Main outcome variables
Disorder in Plantar pressure distribution, ankle sprain, lower extermity injury
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200315046781N1
Registration date:2021-02-21, 1399/12/03
Registration timing:prospective
Last update:2021-02-21, 1399/12/03
Update count:0
Registration date
2021-02-21, 1399/12/03
Registrant information
Name
Mahdieh Zareei
Name of organization / entity
Bu Ali Sina University
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1423
Email address
m.zareie@phe.basu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-09, 1400/01/20
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 eight-weeks corrective intervention on balance, proprioception and plantar pressure variables in woman with limited ankle dorsiflexion
Public title
The effect of eight-weeks corrective intervention on balance, proprioception and plantar pressure variables
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having an active dorsiflexion angle of less than 20 degrees in sitting position
Having at least three training sessions per week
Exclusion criteria:
History of any injury in the past six months
History of lower extremity surgery
Age
From 15 years old to 26 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Random Number Generator software is randommized and then assigned to double groups based on SNOSE allocation hiding
Blinding (investigator's opinion)
Single blinded
Blinding description
Particioants,outcome assessors and data analyzes do their job assuming all participants receive training
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Approval date
2020-02-26, 1398/12/07
Ethics committee reference number
IR.BASU.REC.1398.056
Health conditions studied
1
Description of health condition studied
Limited ankle dorsiflexion
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Plantar pressure variables
Timepoint
Before the intervention begins, One day after the end of the intervention
Method of measurement
RSscan Device
2
Description
Balance
Timepoint
Before the intervention begins, One day after the end of the intervention
Method of measurement
Y-Balance Test
3
Description
Proprioception
Timepoint
Before the intervention begins, One day after the end of the intervention
Method of measurement
goniometer
Secondary outcomes
1
Description
Disorder in Plantar pressure Distribution
Timepoint
Before the intervention begins, One day after the end of the intervention
Method of measurement
RSscan Device
2
Description
imbalance
Timepoint
Before the intervention begins, One day after the end of the intervention
Method of measurement
Y-Balance Test
3
Description
disorder in Proprioception
Timepoint
Before the intervention begins, One day after the end of the intervention
Method of measurement
goniometer
Intervention groups
1
Description
Intervention group: Corrective Exercises will last for 8 weeks and 3 sessions per week .Equipment such as step and strap will be used for the exercises.
Category
Rehabilitation
2
Description
Control group: No Intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Committee of volleyball and basketball of Hamedan
Full name of responsible person
Mahdieh Zareei
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1423
Email
m.zareie@phe.basu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Farzaneh saki
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1423
Email
F_saki@basu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bu Ali Sina University
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
Bu Ali Sina University
Full name of responsible person
Mahdieh Zareei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Rehabilitation
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1423
Email
m.zareie@phe.basu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Mahdieh Zareei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Rehabilitation
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1423
Email
m.zareie@phe.basu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Mahdieh Zareei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Rehabilitation
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1423
Email
m.zareie@phr.basu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available