Protocol summary
-
Study aim
-
The effect of hybrid knee brace, consisting of a functional brace and an elastic sleeve, after acute rupture of ACL, on coping ability and neuromuscular parameters after acute injury of the anterior cruciate ligament.
-
Design
-
Clinical trial with community based and practice-oriented test and control group, with parallel groups, single-blind, simple randomization method
-
Settings and conduct
-
Sampling at Shafa Yahyaiyan Hospital, evaluation at the Sport Sciences Research Institute of Iran by the Biodox system 4 dynamometer and relevant questionnaires, tests include maximum muscle strength of the quadriceps, then 30% and 50% of MVC for assessing steadiness of Quadriceps, duration of 6-meter single-leg hop test will be recorded, one-way blindness
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: people between 18 to 40 years old; unilateral and isolated ACL rupture; maximum three months after injury; 3-5 grade of the Tagner Questionnaire; no cartilage damage; lack of fracture or dislocation; no history of fracture and previous surgery in the knee joint; no history of previous ACL or meniscal or other ligaments injuries.
Exclusion criteria: unwillingness to continue cooperation; failure to comply with the rehabilitation protocol; knee pain and inflammation during the performance tests.
-
Intervention groups
-
Samples allocation from patients with complete anterior cruciate ligament rupture referring to the knee clinic at Shafa Yahyayan Hospital. The intervention in the test group includes a custom knee brace fabricated by taking measures of the individual's body, plus an appropriate size of sleeve, In the control group, there is no orthosis intervention, and people receive only physical therapy.
-
Main outcome variables
-
Coping condition of patients; Tampa questionnaire score; duration of a six-meter hop test; steadiness of the sub maximal muscular force of the quadriceps
General information
-
Reason for update
-
The start and end dates of patient recruitment and the end date of the clinical trial were recorded.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20181003041219N1
Registration date:
2018-11-03, 1397/08/12
Registration timing:
prospective
Last update:
2020-04-14, 1399/01/26
Update count:
1
-
Registration date
-
2018-11-03, 1397/08/12
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2018-11-03, 1397/08/12
-
Expected recruitment end date
-
2018-12-21, 1397/09/30
-
Actual recruitment start date
-
2018-12-01, 1397/09/10
-
Actual recruitment end date
-
2019-06-29, 1398/04/08
-
Trial completion date
-
2019-08-14, 1398/05/23
-
Scientific title
-
The effect of hybrid knee brace on coping ability and neuromuscular parameters after acute anterior cruciate ligament tear
-
Public title
-
The effect of hybrid knee brace on acute anterior cruciate ligament tear
-
Purpose
-
Supportive
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Unilateral isolated tear of anterior cruciate ligament
Injury within last three month
Required 3-5 scores from Tegner questionnaire
Exclusion criteria:
The presence of damage to the meniscus confirmed by MRI
The presence of cartilage damage
The presence of fracture or dislocation with ACL rupture
The history of fracture and previous surgery in the knee joint
The history of previous ACL or meniscal or other ligaments injuries
-
Age
-
From 18 years old to 40 years old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
- Participant
- Care provider
-
Sample size
-
Target sample size:
26
Actual sample size reached:
26
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
In this study, simple randomization method will be used. 26 cards, numbered from 1 to 26, are poured into the container. Then, each time, a card containing one number is randomly taken out of the container. In this way, 13 cards are selected and the registration number is considered as the numbers of test group. The remaining numbers in the container are considered as the control group. Subsequently, people entering the study according to inclusion criteria are randomized in the test or control group, respectively.
-
Blinding (investigator's opinion)
-
Single blinded
-
Blinding description
-
In this study, blindness is done in one direction. So that the participants in the study do not know if they are in the control or test group. A specialist physician who will evaluate and refer patients will also be blind.
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
So far, a study based on orthosis intervention in the acute stage of the anterior cruciate ligament rupture has not been done to increase the number of copers. The result of the present study may increase the number of copers and reduce the likelihood of reconstruction surgery. Another aspect of this study is introducing a hybrid brace that benefits from the use of hard and soft braces simultaneously and also changes in the structure of the hard part for specific instability control after anterior cruciate ligament rupture. Finally, the effect of using the hybrid brace is evaluated by measuring the quadriceps steadiness, which indicates the level of coordination of the musculoskeletal system after the intervention.
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2018-07-10, 1397/04/19
-
Ethics committee reference number
-
IR.IUMS.REC.1397.049
Health conditions studied
1
-
Description of health condition studied
-
Anterior cruciate ligament rupture
-
ICD-10 code
-
S83.51
-
ICD-10 code description
-
Sprain of anterior cruciate ligament of knee
Primary outcomes
1
-
Description
-
Quadriceps steadiness
-
Timepoint
-
Acute stage
-
Method of measurement
-
Biodex dynamometer
Intervention groups
1
-
Description
-
Intervention group: Individuals with acute anterior cruciate ligament rupture, intervention including using a hybrid brace for one month, and performing routine physiotherapy for ten sessions to reduce pain, edema and increase knee range of motion, then determine the person's compatibility with injury and measure the stability of the quadriceps muscle by Biodex Isokinetic dynamometer
-
Category
-
Rehabilitation
2
-
Description
-
Control group: Individuals with acute rupture of the anterior cruciate ligament, routine intervention including ten sessions of physiotherapy to reduce pain, edema and increase knee range of motion, then determine the person's compatibility with injury and measure the stability of the quadriceps muscle by Biodex Isokinetic dynamometer
-
Category
-
Rehabilitation
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Iran 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
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
-
No more information
-
Study Protocol
-
No - There is not a plan to make this available
-
Statistical Analysis Plan
-
Not applicable
-
Informed Consent Form
-
No - There is not a plan to make this available
-
Clinical Study Report
-
No - There is not a plan to make this available
-
Analytic Code
-
Not applicable
-
Data Dictionary
-
Not applicable