Protocol summary
-
Study aim
-
Comparison the effect of gait retraining along with feedback with rehabilitation targeting exercises on trunk and lower extremity kinetic and kinematic of patients with groin pain.
-
Design
-
The statistical population of the present study consists of men aged 18-35 with groin pain, among whom 48 people were selected based on the criteria for entering the research purposefully and randomly into two intervention groups and one control group (each group included 16 people) are divided. One group performs targeted rehabilitation interventions, and the other group undergoes gait retraining along with visual and verbal feedback. The control group also continues the special routine exercises of their sport.
-
Settings and conduct
-
The study was performed on footballers with groin pain in the Kharazmi University Correctional Laboratory. Squeeze test is used to evaluate the pain variable, and motion analysis systems are used to evaluate the kinetic and kinematic variables during a cutting maneuver. These assessments are pre and post test. In this research, the evaluator is kept blind, so that one researcher who has no knowledge of how to allocate subjects in groups, performs the evaluation.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: groin pain history; intention to return to competitive sports; positive Squeeze testing; painful touch on the adductor tendon. Exclusion criteria: hip joint osteoarthritis; primary medical conditions; pain in the thoracolumbar area; performing hip adductor strengthening exercises.
-
Intervention groups
-
Intervention Group 1: This group receives rehabilitation exercises at three levels. Intervention Group 2: This group receives a gait retraining program along with visual and verbal feedback. Control group: This group continues the specific routine exercises of their sport.
-
Main outcome variables
-
Groin pain; Kinetic; Kinematic
General information
-
Reason for update
-
Enter information about the realized sample size, the start and end dates of the realized patient, and the end date of the clinical trial.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20200401046908N1
Registration date:
2020-05-02, 1399/02/13
Registration timing:
prospective
Last update:
2020-10-20, 1399/07/29
Update count:
1
-
Registration date
-
2020-05-02, 1399/02/13
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2020-04-13, 1399/01/25
-
Expected recruitment end date
-
2020-06-17, 1399/03/28
-
Actual recruitment start date
-
2020-05-04, 1399/02/15
-
Actual recruitment end date
-
2020-07-08, 1399/04/18
-
Trial completion date
-
2020-10-20, 1399/07/29
-
Scientific title
-
Comparison the effect of gait retraining along with feedback with rehabilitation targeting exercises on trunk and lower extremity kinetic and kinematic of patients with groin pain.
-
Public title
-
Comparison of gait retraining intervention along with feedback with rehabilitation targeting exercises on biomechanics of patients with groin pain.
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Men 18-35 years old have groin pain for at least 2 months
People who intend to return to the same level of preinjury participation in competitive multidirectional sports
Those who have a positive Squeeze test (at 45 degrees of hip flexion)
Those who have painful palpation in the tendon of the adductor or its connections to the pubic bone
Exclusion criteria:
People with hip joint osteoarthritis
Those with underlying medical conditions such as arthritis or infection
People who feel pain in the thoracolumbar area
Athletes who performed hip adductor strengthening exercises more than once a week for six months before the study
-
Age
-
From 18 years old to 35 years old
-
Gender
-
Male
-
Phase
-
N/A
-
Groups that have been masked
-
-
Sample size
-
Target sample size:
51
Actual sample size reached:
48
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
To randomize, the names of each subject are written on a ball after being selected and placed inside a bag, and a person is asked to take them out of the bag and randomly place 1: 1: 1 in one of three study groups.
-
Blinding (investigator's opinion)
-
Single blinded
-
Blinding description
-
One researcher who is evaluating the outcome is kept blind. In this way, he does not know how the subjects are assigned to the groups and what treatment interventions each group of subjects receives. In this way, he does not make deliberate mistakes in his judgments and does not benefit from the new treatment intervention.
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2020-01-12, 1398/10/22
-
Ethics committee reference number
-
IR.KHU.REC.1398.056
Health conditions studied
1
-
Description of health condition studied
-
Groin pain
-
ICD-10 code
-
-
ICD-10 code description
-
Primary outcomes
1
-
Description
-
Groin Pain
-
Timepoint
-
Pre and post test
-
Method of measurement
-
sphygmomanometer
Secondary outcomes
1
-
Description
-
Kinetic: Ankle moment sagittal (plantar)
-
Timepoint
-
Pre and post test
-
Method of measurement
-
Force plate
2
-
Description
-
Kinetic: Ankle power sagittal (eccentric)
-
Timepoint
-
Pre and post test
-
Method of measurement
-
Force plate
3
-
Description
-
Kinetic: Ankle power sagittal (concentric)
-
Timepoint
-
Pre and post test
-
Method of measurement
-
Force plate
4
-
Description
-
Kinetic: Hip power sagittal (concentric)
-
Timepoint
-
Pre and post test
-
Method of measurement
-
Force plate
5
-
Description
-
Kinetic: Hip moment sagittal (extensor)
-
Timepoint
-
Pre and post test
-
Method of measurement
-
Force plate
6
-
Description
-
Kinetic: Knee power sagittal (concentric)
-
Timepoint
-
Pre and post test
-
Method of measurement
-
Force plate
7
-
Description
-
Kinetic: Hip moment frontal (adductor)
-
Timepoint
-
Pre and post test
-
Method of measurement
-
Force plate
8
-
Description
-
Kinematic: Thorax angles frontal (contralateral side flexion)
-
Timepoint
-
Pre and post test
-
Method of measurement
-
Three-dimensional motion analysis system
9
-
Description
-
Kinematic: Pelvis angles transverse (contralateral rotation)
-
Timepoint
-
Pre and post test
-
Method of measurement
-
Three-dimensional motion analysis system
10
-
Description
-
Kinematic: Pelvis angles frontal (contralateral side flexion)
-
Timepoint
-
Pre and post test
-
Method of measurement
-
Three-dimensional motion analysis system
11
-
Description
-
Kinematic: Ankle angles sagittal (dorsiflexion)
-
Timepoint
-
Pre and post test
-
Method of measurement
-
Three-dimensional motion analysis system
12
-
Description
-
Kinematic: Thorax angles transverse (ipsilateral rotation)
-
Timepoint
-
Pre and post test
-
Method of measurement
-
Three-dimensional motion analysis system
13
-
Description
-
Kinematic: Hip angles sagittal (flexion)
-
Timepoint
-
Pre and post test
-
Method of measurement
-
Three-dimensional motion analysis system
14
-
Description
-
Kinematic: Hip angles frontal (abduction)
-
Timepoint
-
Pre and post test
-
Method of measurement
-
Three-dimensional motion analysis system
15
-
Description
-
Kinematic: Knee angles sagittal (flexion)
-
Timepoint
-
Pre and post test
-
Method of measurement
-
Three-dimensional motion analysis system
16
-
Description
-
Kinematic: Ground contact time
-
Timepoint
-
Pre and post test
-
Method of measurement
-
Three-dimensional motion analysis system
Intervention groups
1
-
Description
-
Intervention group 1: This group will implement a targeted rehabilitation protocol that includes three levels; level 1 addressed intersegmental control and strength, level 2 involved linear running mechanics and increasing linear running load tolerance, and level 3 targeted multidirectional mechanics and the transition back to high intensity sprinting. Exercises are performed 3 days a week, one day in between, for 8 weeks. The rest time between each set is 30 seconds to 1 minute.
-
Category
-
Treatment - Other
2
-
Description
-
Intervention group 2: This group performs gait retraining along with visual and verbal feedback. Gait retraining is done on a treadmill. People run on the treadmill at a comfortable pace in all sessions. Visual feedback during running through a full-length mirror that is placed directly in front of the treadmill, and verbal feedback in the form of instructions such as "keeping the knees in line with the toes, reducing pelvic prolapse and maintaining pelvic symmetry, reducing vertical acceleration (by inducing a quiet and quiet walking style)" provided by the tester. In general, the training time starts from 15 minutes in the first session and is increased to 3 to 9 minutes per week. While feedback time is reduced from 100% in the first four weeks to 25% in the last few weeks and then removed. Exercises are followed 1 day a week for 8 weeks.
-
Category
-
Treatment - Other
3
-
Description
-
Control group: This group continues the specific routine exercises of their sport.
-
Category
-
N/A
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
kharazmi University
-
Proportion provided by this source
-
50
-
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
-
There is no further information.
-
Study Protocol
-
Yes - There is a plan to make this available
-
Statistical Analysis Plan
-
No - There is not a plan to make this available
-
Informed Consent Form
-
Yes - There is a plan to make this available
-
Clinical Study Report
-
No - There is not a plan to make this available
-
Analytic Code
-
No - There is not a plan to make this available
-
Data Dictionary
-
No - There is not a plan to make this available
-
Title and more details about the data/document
-
Only part of the data, such as dependent variables, the average of all samples, can be shared in the form of scientific articles.
-
When the data will become available and for how long
-
Start accessing 6 months after publishing results in articles and obtaining permission from the relevant university.
-
To whom data/document is available
-
Personal information is confidential and general outcomes in paper form available to everyone.
-
Under which criteria data/document could be used
-
Information is not available to anyone. General outcomes in paper form available to everyone.
-
From where data/document is obtainable
-
Sarvenaz Kazempour
Email: kazempour.sarvenaz@yahoo.com
-
What processes are involved for a request to access data/document
-
Information can be provided by contacting Sarvanaz Kazempour and coordinating with the Department of Sports Pathology of Kharazmi University of Tehran.
-
Comments
-