Investigating the effect of biofeedback on proprioception , balance , strength of the quadriceps and knee function following anterior cruciate ligament reconstruction
Determining the effect of biofeedback on proprioception, balance and function following anterior cruciate ligament reconstruction
Design
In this randomized double-blind clinical trial study, patients were randomly divided into two groups of 20 based on a random number table: biofeedback technique and routine rehabilitation exercises and control of routine rehabilitation exercises.
Settings and conduct
Patients who are candidates for anterior cruciate ligament reconstruction referred to Akhtar Hospital will be randomly divided into two groups of 20 in one of the intervention / control groups.
Participants/Inclusion and exclusion criteria
This study will be performed on patients with anterior cruciate ligament reconstruction in Tehran in 2021-2022 and patients will not enter the study with the dissatisfaction of participating in the study.
Intervention groups
Intervention group (Biofeedback techniques and common rehabilitation exercises) : Patients will practice in a standing position, mini-squat, knee extension with maximum isometric contraction in front of a computer that provides visual and auditory feedback, and individuals should increase the maximum threshold for muscle contraction. The intervention is held for 4 weeks and three sessions per week for each person and the duration of each session is 45 minutes.
Control group: Patients perform common rehabilitation exercises including weightlifting, SLR and quad set exercises for 4 weeks and three sessions per week, each lasting 45 minutes.
Main outcome variables
Proprioception, balance and anterior cruciate ligament function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211113053048N1
Registration date:2021-11-20, 1400/08/29
Registration timing:prospective
Last update:2021-11-20, 1400/08/29
Update count:0
Registration date
2021-11-20, 1400/08/29
Registrant information
Name
Ali Asghar Jameh Bozorgi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7754 2057
Email address
aas.bozorgi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-05, 1400/09/14
Expected recruitment end date
2022-02-18, 1400/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of biofeedback on proprioception , balance , strength of the quadriceps and knee function following anterior cruciate ligament reconstruction
Public title
The effect of biofeedback on proprioception, balance, strength of the quadriceps and knee function following anterior cruciate ligament reconstruction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Unilateral anterior cruciate ligament injury
Age 30-18 years
Patients who have undergone at least 16 sessions of physical therapy and are able to walk without a cane, without pain and inflammation, and with full range of motion of the knee.
At least ten weeks have passed since surgery
No neuromuscular disease, length difference between limbs, addiction to drugs and alcohol and any complication of the peripheral and central nervous system that disturbs the balance
Patients who do not have cognitive, visual or auditory problems
Patients who did not receive biofeedback therapy or similar during the intervention.
Do not take medication that affects balance
Consent to participate in the project
Exclusion criteria:
Dissatisfaction with participating in the project
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups based on a table of random numbers.First, we define the framework of our statistical community, determine the exact number of people in the community, and code them in order.If the total number of people in a community is a two-digit or three-digit number or more, the codes and numbers assigned to members of the community must be the same.To select sample people from the table, we randomly start from a table point in the row or column direction. Point selection can be done by closing the eyes and placing a finger or the tip of a pen on the table. We only select smaller numbers. The selected number is in fact the individual code of the community that is selected as a sample.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients (intervention or control) will receive encoded sealed envelopes. The coding will be done by one of the project partners and the evaluator and the patient will be blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
next to Ayatollah Taleghani Hospital, Shahid Arabi St., Yemen St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2021-01-31, 1399/11/12
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.1014
Health conditions studied
1
Description of health condition studied
Anterior Cruciate Ligament Reconstruction
ICD-10 code
S83.512A
ICD-10 code description
Sprain of anterior cruciate ligament of left knee, init ·
Primary outcomes
1
Description
Proprioception
Timepoint
Before and after treatment
Method of measurement
Using a digital camera, the patient must estimate the angles defined for the injured knee.
2
Description
Balance
Timepoint
Before and after treatment
Method of measurement
Using the plate machine, the static balance is measured in four positions: standing on two legs with open eyes, standing on two legs with closed eyes, standing on one with open eyes, standing on one with closed eyes, and dynamic balance of activities. Used to transfer weight along the anterior-posterior, internal, or external surfaces of a computer screen.
3
Description
Strength of the quadriceps
Timepoint
Before and after treatment
Method of measurement
Quadriceps muscle strength using a dynamometer
4
Description
knee function
Timepoint
Before and after treatment
Method of measurement
KOOS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: (Biofeedback techniques and common rehabilitation exercises) : Patients will practice in a standing position, mini-squat, knee extension with maximum isometric contraction in front of a computer that provides visual and auditory feedback, and individuals should increase the maximum threshold for muscle contraction. The intervention is held for 4 weeks and three sessions per week for each person and the duration of each session is 45 minutes.
Category
Treatment - Devices
2
Description
Control group: Patients perform common rehabilitation exercises including weightlifting, SLR and quad set exercises for 4 weeks and three sessions per week, each lasting 45 minutes.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhtar Hospital
Full name of responsible person
Ali Asghar Jameh Bozorgi P.H.D
Street address
In front of Bouali Hospital, Damavand Street (New Tehran), Tehran