Protocol summary

Study aim
Purpose of this research is to study the effect of 8-weeks physical rehabilitation exercises on motor function and micro-structure of injured meniscus in athletes.
Design
Clinical experiment was composed of 24 athletes with meniscus injury that were selected by purposive sampling and were divided into control and experimental groups randomly.
Settings and conduct
Method and type of this study is semi-experimental and applied. This study was accomplished in orthopedic clinics to find subjects, rehabilitation faculty lab to record variables, exercise site to implement protocol, hospital for meniscectomy, and pathobiology lab to prepare the tissue. Surveys were done before and after 8 weeks (control: not exercised and experimental: exercised; intergroup comparison) and after surgery (intragroup comparison).
Participants/Inclusion and exclusion criteria
Study entry criteria include subjects being volunteer for meniscectomy; not more than six months is passed from their injury; is volunteer to participate in the exercise program. Condition for not entering this study was subsiding from it in the middle of the research for any reason.
Intervention groups
Torque, balance, range of motion, and proprioception of the injured knee were measured before and after 8 weeks (control: not exercised; experimental: selective rehabilitation exercise). Meniscectomy was performed on both groups and during meniscectomy injured meniscus tissue was removed. Then surface topography, surface profile, surface roughness, number of surface fibrocartilages, and diameter of fibrocartilages were deliberated in both groups.
Main outcome variables
Eight weeks of selective rehabilitation program improved motor function (knee muscle torque; balance; ROM; and knee proprioception) and micro-structure (meniscus surface roughness; number of meniscus fibrocartilages; diameter of fibrocartilages) in injured athletes.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200507047331N1
Registration date: 2020-06-15, 1399/03/26
Registration timing: registered_while_recruiting

Last update: 2020-06-15, 1399/03/26
Update count: 0
Registration date
2020-06-15, 1399/03/26
Registrant information
Name
Seyede Mona Hosseini
Name of organization / entity
University of Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 21 2234 5000
Email address
mona_s1379@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-24, 1399/03/04
Expected recruitment end date
2020-07-25, 1399/05/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of 8-weeks selected physical rehabilitation exercises on motor function and micro-structure of meniscus in injured athletes
Public title
Effect of exercise on motor function and micro-structure of injured meniscus
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Be a volunteer for meniscectomy Not more than six months is passed from the time of his/her meniscus injury Having surgery up to three month after acquaintance with the study Having specific severity in injury which is diagnosed by the surgeon Be a volunteer for participating in the exercise protocol
Exclusion criteria:
Age
From 18 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 25
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 the Isfahan University
Street address
Isfahan University, Azadi Sq.
City
Isfahan
Province
Isfehan
Postal code
8174673441
Approval date
2020-05-23, 1399/03/03
Ethics committee reference number
IR.UI.REC.1399.006

Health conditions studied

1

Description of health condition studied
Meniscus Injury (Musculoskeletal Injury)
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Maximum torque of knee flexor muscles
Timepoint
Before and after eight weeks of exercise
Method of measurement
Biodex Isokinetic Dynamometer

2

Description
Maximum torque of knee extensor muscles
Timepoint
Before and after eight weeks of exercise
Method of measurement
Biodex Isokinetic Dynamometer

3

Description
Overall static balance index
Timepoint
Before and after eight weeks of exercise
Method of measurement
Biodex Balance System SD

4

Description
Anteroposterior static balance index
Timepoint
Before and after eight weeks of exercise
Method of measurement
Biodex Balance System SD

5

Description
Mediolateral static balance index
Timepoint
Before and after eight weeks of exercise
Method of measurement
Biodex Balance System SD

6

Description
Overall dynamic balance index
Timepoint
Before and after eight weeks of exercise
Method of measurement
Biodex Balance System SD

7

Description
Anteroposterior dynamic balance index
Timepoint
Before and after eight weeks of exercise
Method of measurement
Biodex Balance System SD

8

Description
Mediolateral dynamic balance index
Timepoint
Before and after eight weeks of exercise
Method of measurement
Biodex Balance System SD

9

Description
Absolute repositioning active angle error
Timepoint
Before and after eight weeks of exercise
Method of measurement
Biodex Isokinetic Dynamometer

10

Description
Knee extension range of motion
Timepoint
Before and after eight weeks of exercise
Method of measurement
Biodex Isokinetic Dynamometer

11

Description
Roughness of meniscus surface
Timepoint
Post surgery
Method of measurement
Atomic Force Microscope

12

Description
Number of meniscus fibrocartilages
Timepoint
Post surgery
Method of measurement
Atomic Force Microscope

13

Description
Diameter of meniscus fibrocartilages
Timepoint
Post surgery
Method of measurement
Atomic Force Microscope

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: one hour daily of selective rehabilitation exercises for eight weeks composed of stretch, strengthening, and balance exercises applied by the researcher based on FITT principles. These exercises were modified by the associated orthopedic surgeon.
Category
Rehabilitation

2

Description
Control group: did not receive any intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Sadi Hospital
Full name of responsible person
Abbas Rahimi
Street address
Sadi Hospital, Khodaverdi Alley, West Nazar St.
City
Isfahan
Province
Isfehan
Postal code
8166886163
Phone
+98 31 3627 3031
Email
info@sadihospital.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Isfahan
Full name of responsible person
Vazgen Minasian
Street address
University of Isfahan, Azadi Sq.
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2128
Fax
+98 31 3668 7396
Email
info@ui.ac.ir
Web page address
https://ui2.ui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Isfahan
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
University of Isfahan
Full name of responsible person
Seyede Mona Hosseini
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Sport Injuries and Corrective Exercise
Street address
No. 7, Apt. 4, Yas Ct., Shahid Soori St., Evin, Chamran Highway
City
Tehran
Province
Tehran
Postal code
1997657557
Phone
+98 21 2234 5000
Fax
Email
mona_s1379@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Seyede Mona Hosseini
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Sport Injuries and Corrective Exercise
Street address
No. 7, Apt. 4, Yas Ct., Shahid Soori St., Evin, Chamran Highway
City
Tehran
Province
Tehran
Postal code
1997657557
Phone
+98 21 2234 5000
Fax
Email
mona_s1379@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Seyede Mona Hosseini
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Sport Injuries and Corrective Exercise
Street address
No. 7, Apt. 4, Yas Ct., Shahid Soori St., Evin, Chamran Highway
City
Tehran
Province
Tehran
Postal code
1997657557
Phone
+98 21 2234 5000
Fax
Email
mona_s1379@yahoo.com

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
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