Comparing the effect of dual task balance training with single task balance training in subjects with anterior cruciate ligament reconstruction: A randomized controlled trial
Main objective: The effect of balance training with secondary cognitive task in comparison with balance training separately on postural control, activity level and functional ability of individuals with unilateral anterior cruciate ligament reconstruction.
Design
A randomized clinical trial with a control group with parallel, double-blind, randomized groups on 26 patients divided into two groups by blocking.
Settings and conduct
Referred patients will be evaluated and if they meet the necessary conditions and after obtaining informed consent, they will be included in the study. First, the initial evaluation of the tests will be performed from the patients and the results will be recorded. Patients will be randomly assigned (using closed envelopes) to control and intervention groups. Patients will be evaluated and treated in private clinic and Ghaem hospital in Mashhad.
Participants/Inclusion and exclusion criteria
This project is performed on people with anterior cruciate ligament reconstruction aged 16 to 50 years, patients must be at least 6 weeks past ACL reconstruction surgery (at least 40 seconds on the injured leg can stand), at least 120 degree range of motion for knee flexion and can walk without any helps.
Intervention groups
In both groups, patients will receive FES for 15 minutes and a series of conventional physiotherapy treatments will be performed for 15 minutes including strengthening, stretching and mobilizing knee joint sets. Then balance exercises are performed by the patient under the supervision of the physiotherapist. In the intervention group, balance exercises are performed simultaneously with the secondary cognitive task and in the control group, balance exercises are performed separately.
Main outcome variables
Star Excursion Balance Test
Single leg Stance on Force Platform
Tegner Activity Scale
The Knee Injury and Osteoarthritis Outcome Score (KOOS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220705055372N1
Registration date:2022-08-19, 1401/05/28
Registration timing:prospective
Last update:2022-08-19, 1401/05/28
Update count:0
Registration date
2022-08-19, 1401/05/28
Registrant information
Name
Mohammad Reza Amirinejad Robot
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3413 1421
Email address
amirinezhadmr@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of dual task balance training with single task balance training in subjects with anterior cruciate ligament reconstruction: A randomized controlled trial
Public title
The effect of balance training with cognitive task
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Participants age between 16 and 50
At least 6 weeks have passed since ACL reconstruction surgery (at least 40 seconds on the injured leg can stand)
Have minimal inflammation
There is a minimum range of motion of 120 degrees for knee flexion
Able to walk without any help
Sensory and motor function of the lower extremity of the person is healthy
Exclusion criteria:
Patient has neurological problems, heart and respiratory diseases
Have a history of neuromuscular diseases and surgery in the lower extremities
The patient has vision problems and vestibolar disorders
The rate of pain during evaluation on the VAS scale is greater than 2
The patient should take a reduced consciousness and hypnotic drug
Patients have osteoporosis, knee osteoarthritis and fractures in the lower extremities
Age
From 16 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Random block allocation method with volume 4 will be used.
All possible 4 permutations will be listed in two groups. (Permutations 1 to 6 as follows)
A is the intervention group and B is the control group.
1-AABB
2-ABAB
3-BAAB
4-BABA
5-BBAA
6-ABBA
Then, from the random numbers table with random starting point, 6 will be selected between 1 and 6 by accident (either using software or randomaize.com site).For example, if the 6 random numbers obtained are 3 5 4 3 4 6, it will mean that the first four are similar to block 3, the second four are similar to block 5 and ... They'll be allocated.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, evaluators, analyzer were kept blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Yazdan Building , Sadeghiyeh18, Sadeghiyeh Blvd,
City
Mashhad
Province
Razavi Khorasan
Postal code
9186391111
Approval date
2022-06-28, 1401/04/07
Ethics committee reference number
IR.MUMS.FHMPM.REC.1401.063
Health conditions studied
1
Description of health condition studied
People or patients with anterior cruciate ligament reconstruction
ICD-10 code
S83.5
ICD-10 code description
Sprain of cruciate ligament of knee
Primary outcomes
1
Description
Star Excursion Balance Test
Timepoint
This assessment is done before and after treatment.
Method of measurement
This tool is used as a widely used dynamic test for clinical and research trials that evaluate a person's dynamic balance and this test requires strength, flexibility and depth perception. While standing on one leg (injured leg), the tester must move the other leg along eight directions and the person's displacement will be measured and will be calculated as the person's score.
Secondary outcomes
1
Description
Single Leg Stance on Force Platform
Timepoint
This assessment is done before and after treatment.
Method of measurement
The force plate is a tool that measures information about the state of the body and uses oscillation amplitude to evaluate this information. This amplitude is obtained from the minimum and maximum distance from the pressure center recorded by the device, and the lower the amplitude, the better the stability. Another parameter of the force plate is the sway speed, which is defined as the total displacement of the center of pressure on the total time the person has been on the device, and the lower the sway speed, the better the state stability of the individual.
2
Description
Tegner Activity Scale
Timepoint
This assessment is done before and after treatment.
Method of measurement
This scale is used to record the activity level of both groups. The numerical amplitude of this scale is in the range of 0-10. The higher the score on this scale, the higher the activity level.
3
Description
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Timepoint
This assessment is done before and after treatment.
Method of measurement
A questionnaire used to assess the outcome of knee injuries and knee joint function. This questionnaire includes 5 dimensions related to pain, symptoms related to illness, life activities, recreational sports activities and quality of life. The score of this questionnaire is between 0-100, which means the maximum disability score and the score of 100 means that the person has no disability.
Intervention groups
1
Description
Intervention group: patients receive 60 minutes of treatment for 4 weeks and 3 sessions per week in a total of 12 sessions. In the intervention group, patients are initially treated with conventional physiotherapy for 30 minutes and then perform balance exercises that coincide with cognitive task for 30 minutes.
Category
Rehabilitation
2
Description
Control group: patients receive 60 minutes of treatment for 4 weeks and 3 sessions per week in a total of 12 sessions. In the control group, patients are initially treated with conventional physiotherapy for 30 minutes and then perform balance exercises separately for 30 minutes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Mahmood Mohammadzade Shabestari
Street address
Imam Reza Research and Treatment Center, Imam Reza Square, Ibn Sina St
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
shabestarim@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mobarhan
Street address
Vice Chancellor for Research and Technology, University of Medical Sciences, University St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
ghayourM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Neda Mostafaee
Position
Assistance Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Paramedical Sciences, University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3884 6710
Email
neda_mostafaee@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Reza Amirinejad Robat
Position
Master Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Yazdan Building, Sadeghiyeh18, Sadeghiyeh Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9186391111
Phone
+98 34 3413 1421
Email
amirinezhadmr@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Reza Amirinejad Robat
Position
Master Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Yazdan Building, Sadeghiyeh18, Sadeghiyeh Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9186391111
Phone
+98 34 3413 1421
Email
amirinezhadmr@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
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