Effectiveness of the knee sleeve equipped with vibrator in comparison with custom knee sleeve on knee function in individuals with anterior cruciate ligament reconstruction
The evaluation of the effect of the neoprene knee sleeve equipped with a local muscle vibrator in comparison with a conventional neoprene knee sleeve on the ability to adapt to injury and neuromuscular parameters in individuals with anterior cruciate ligament reconstruction
Design
A randomized clinical trial with parallel open-label control group
Settings and conduct
This study will be carried out at The Shiraz University of Medical Science. Participants in this study will be randomly assigned to the control and intervention groups. Before receiving the orthotic intervention, the biomechanical tests will be taken from all participants in both groups. Then, the participants of this study will receive the orthotic intervention related to their groups and after 6 weeks of using the orthotic intervention, they will be biomechanically tested again.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Individuals with anterior cruciate ligament reconstruction
2- Have isolated anterior cruciate ligament rupture
3-Ages of 18 and 40
Exclusion criteria:
1- Having significant deformities in lower limbs
Intervention groups
Intervention group: The soft knee sleeve equipped with local muscle vibrators
Control group: The conventional soft knee sleeve
Main outcome variables
Level of daily activity; the electrical activity of the muscle
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160904029684N4
Registration date:2021-08-23, 1400/06/01
Registration timing:prospective
Last update:2021-08-23, 1400/06/01
Update count:0
Registration date
2021-08-23, 1400/06/01
Registrant information
Name
Kourosh Barati
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 935 882 7110
Email address
barati.k@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of the knee sleeve equipped with vibrator in comparison with custom knee sleeve on knee function in individuals with anterior cruciate ligament reconstruction
Public title
Effects of vibratory knee sleeve on people with anterior cruciate ligament reconstruction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Body mass index in the range of 5-18-30
People aged 18 to 40 years
Unilateral rupture and isolation of the anterior cruciate ligament confirmed by MRI
A maximum of three months have elapsed since the injury
Obtaining a score of 3-5 from the Tegner questionnaire (average level of activity)
Exclusion criteria:
Deformity in the lower extremities
MRI-confirmed meniscus damage
Associated cartilage damage
Fractures or dislocations with ACL rupture
History of fracture or previous surgery in the knee joint area
Previous history of ACL or meniscus or other ligament damage
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Participants in the research will be divided into two groups of intervention and control by simple random sampling. The free website WWW.Randomization .com will be used for randomization.
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 committeee of Baqiyatallah University of Medical Sciences
Street address
Molasadra street
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2021-05-10, 1400/02/20
Ethics committee reference number
IR.BMSU.REC.1400.025
Health conditions studied
1
Description of health condition studied
Anterior cruciate ligament rupture
ICD-10 code
M23.619
ICD-10 code description
Other spontaneous disruption of anterior cruciate ligament of unspecified knee
Primary outcomes
1
Description
Level of electrical activity of the muscle
Timepoint
Before the intervention and 6 weeks after receiving the intervention
Method of measurement
Electromyography
2
Description
Level of activity of daily living
Timepoint
Before the intervention and 6 weeks after receiving the intervention
Method of measurement
Tegner questionaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Individuals in the intervention group will use a soft knee sleeve equipped with a local muscle vibrator for 6 weeks. The knee sleeve is made of neoprene tissue. In its structure, a local muscle vibrator will be used to stimulate the quadriceps muscle. The participants will be instructed to use the orthosis for at least 8 hours a day.
Category
Rehabilitation
2
Description
Control group: The participants in the control group will use a conventional soft knee sleeve for 6 weeks. The knee sleeve is quite similar to the neoprene knee sleeve equipped with a vibrator received by the intervention group, except having no vibrator in its structure. The participants will be instructed to use the orthosis for at least 8 hours a day.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz University of Medical Science
Full name of responsible person
Alireza Shamsodini
Street address
School of Rehabilitation Science, Chamran Ave., Shiraz
City
Shiraz
Province
Fars
Postal code
3366971947
Phone
+98 71 3627 1552
Email
Rehab@Sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad taghi Karimi
Street address
School of Rehabilitation Science, Chamran Ave., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
3366971947
Phone
+98 71 3627 1552
Email
Rehab@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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Alireza Shamsoddini
Position
Research Assistant Professor of Exercise Physiology
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Mollasadra street
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
shamseddin23@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Alireza Shamsoddini
Position
Research Assistant Professor of Exercise Physiology
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Mollasadra street
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
Shamseddin23@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Alireza Shamsoddini
Position
Research Assistant Professor of Exercise Physiology
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Mollasadra street
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
Shamseddin23@gmail.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
Not applicable
Informed Consent Form
No - There is not 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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available