The aim of this study was to compare the results of early rehabilitation with modified early rehabilitation after reconstructive surgery of the anterior cruciate ligament of the knee.
Design
This study includes is a clinical trial that using envelopes 120 patients candidates for anterior cruciate ligament reconstructive surgery randomly assigned to two groups of 60 intervention (Modified early rehabilitation) and control (early rehabilitation).
Settings and conduct
The study will be done in the orthopedic ward of Besat Hospital in Hamadan. The study will be single- blind. In this way, the person who evaluating the outcome of the surgery will be unaware of the intervention and control groups.
Participants/Inclusion and exclusion criteria
Participants in the study will be patients candidates for anterior cruciate ligament repair surgery. Inclusion criteria Patients with anterior cruciate ligament injury of the knee with body mass index above 30. Exclusion criteria include: anterior cruciate ligament rupture with meniscus injury, requires concomitant stotomy, with cartilage damage, and requires cartilage reconstruction and patients with multi-ligament rupture.
Intervention groups
Patients in the intervention group start flexion and extension movements of the knee from the day after surgery and are emphasized that the goal is to achieve at least 90 degrees of range of motion of the knee during the first 2 weeks. The control group is those who within 7-10 days First, in order to gain the range of motion of the knees, they are released, they are not trained. After 7-10 days, both groups will be visited and the same classical physiotherapy begins.
Main outcome variables
The main consequence of the intervention is to obtain at least 90 degrees of range of motion of the knee during the first 2 weeks after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151123025202N13
Registration date:2020-08-19, 1399/05/29
Registration timing:registered_while_recruiting
Last update:2020-08-19, 1399/05/29
Update count:0
Registration date
2020-08-19, 1399/05/29
Registrant information
Name
Abbas Moradi
Name of organization / entity
Hamedan University of Medical Of Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0097
Email address
a.moradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2020-08-20, 1399/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effectiveness of Accelerated Versus Modified Accelerated Rehabilitation After ACL Reconstruction
Public title
Rehabilitation After ACL Reconstruction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ACL isolation rupture
Exclusion criteria:
ACL rupture requiring simultaneous stotomy around the knee
ACL ligament rupture and cartilage damage require cartilage repair
Multi-ligament rupture
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
We made 120 cards and write letter I on 60 for Intervention and on the other 60 letter C for the control group. Then put them inside the envelope with aluminum wrap and put in a box. At the time of patient arrival, one of the envelopes randomly will be selected and will be opened, based on selected letter ( I or C) patients will be assigned to intervention or control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this single-blind study, the individual who measures the final outcome of the intervention in both groups will be unaware of the intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan Univercity of Medical Science
Street address
Shahid Fahmideh avenue, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838697
Approval date
2019-06-15, 1398/03/25
Ethics committee reference number
IR.UMSHA.REC.1398.254
Health conditions studied
1
Description of health condition studied
Sprain of cruciate ligament of knee
ICD-10 code
S83.5
ICD-10 code description
Sprain of cruciate ligament of knee
Primary outcomes
1
Description
Changes in knee range of motion
Timepoint
The first, second, fourth weeks and third and sixth months after surgery
Method of measurement
Goniometer
Secondary outcomes
1
Description
Changes in daily performance and exercise activity
Timepoint
The first, second, fourth weeks and third and sixth months after surgery
Method of measurement
IKDC-2000 questionnaire
Intervention groups
1
Description
Intervention group: Patients will begin to walk one day after the surgery and the flexion and extension movements of the knee begin in them. They will be told that the goal is to get at least 90 degrees of knee range in the first two weeks
Category
Rehabilitation
2
Description
Control group: Patients will begin to walk one day after the surgery and the flexion and extension movements of the knee begin 7-10 days after surgery.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr Gholamreza Ghorbani Amjad
Street address
Shahid Beheshti Blvd
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0030
Fax
+98 81 3265 1515
Email
Besat@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Shahid Fahmide Ave, Hamadan, Iran
City
Hamedan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
vc_research@umsha.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Hamedan shahid fahmideh Ave, medicine school
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0097
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Gholamreza Ghorbani Amjad
Position
Specialty doctorate in Orthopedic
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Behesht Blv, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 912 296 7245
Fax
Email
amjad52m@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shahid Fahmideh Ave, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0097
Fax
+98 81 3838 0208
Email
a.moradi@umsha.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