- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06165783
Rehabilitation of Partially Injured Hamstring Muscles
May 30, 2024 updated by: Kamal Hadib Abdulridha, Universidad de Zaragoza
The Effect of Therapeutic Exercises and Ultrasound for Rehabilitation of Partially Injured Hamstring Muscles in Elite Football Players: a Study Protocol for a Randomized Controlled Trial
The aim of this study protocol is to describe the rationale and methodology for evaluating the effect of using therapeutic exercises and ultrasound in the rehabilitation of partially injured hamstring muscles on elite football players.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Hamstring muscle injuries are common among highly active individuals.
Modern Football is a challenging sport characterized by extremely dynamic and cyclical game motions including numerous bouts of high-speed movements such as accelerating, jumping, and change in direction, all of which are carried out at a high level of physical and technical difficulty.
The most common reason for hamstring muscle injury is high-performance intensity.
In addition, neuromuscular fatigue, athlete aging, low muscle strength, and hamstring muscle flexibility are also risk factors for hamstring muscle injuries.
On the other hand, the main causes of repetition injury to the same muscle are the presence of a previous injury, the size of the muscle tear and the lessening of the long head muscle bundles of the biceps femoris
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Baghdad, Iraq, 10070
- University of Baghdad/ college of Physical Education and Sports Sciences
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion criteria:
- Players from the eight clubs in the Iraqi Football League
Partially strained hamstring muscle pain when training football or playing a match, identified as:
a. Player reported sudden pain in hamstring muscle c. Without any additional ailment.
Based on the clinical signs and symptoms, defined as:
- Localised pain when palpating of hamstring muscle
- Localised pain from at least one of the following activities: The Extender, The Diver, and The Glider.
- MRI-confirmed of partially injured hamstring
- Available for follow-up
Exclusion criteria:
- Players with other injuries apart from hamstring injuries
- Players with a recent six-month history of a verified or suspected hamstring injury in the same leg.
- injured players who are already taking part in another rehabilitation program
- General contraindications for MRI
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: evaluate the effect of using therapeutic exercises and ultrasound
evaluate the effect of using therapeutic exercises and ultrasound for the rehabilitation of partially injured hamstring muscles.
|
describe the rationale and methodology for evaluating the effect of using therapeutic exercises and ultrasound in the rehabilitation of partially injured hamstring muscles
|
|
Experimental: analyse its effectiveness on the speedy healing
analyse its effectiveness on the speedy healing, which will be defined through some physical variables (hamstring muscle strength, the electrical activity of hamstring muscles) and pain perception.
|
describe the rationale and methodology for evaluating the effect of using therapeutic exercises and ultrasound in the rehabilitation of partially injured hamstring muscles
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to return to play
Time Frame: Daily session from first therapy session until moment of return to play, up to an average of Six Weeks
|
The primary outcomes will be speedy healing, that is, the amount of time needed to recover from an injury in order to fully participate in team training and be available for match selection by the medical staff based on five standardized criteria: 1. no pain on palpation 2. pain free Range of Motion (ROM) 3. Muscular strength evaluation 4. Symptom-free completion of rehabilitation program 5. A specific running test.
|
Daily session from first therapy session until moment of return to play, up to an average of Six Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hamstring muscle strength
Time Frame: Daily session from first therapy session until moment of return to play, up to an average of Six Weeks
|
Force Sensor from Chronojump.
Is an sensor measure of to conduct isometric knee flexion strength testing at two distinct angles: 15° and 90° of knee flexion.
|
Daily session from first therapy session until moment of return to play, up to an average of Six Weeks
|
|
Muscle bio potential signals
Time Frame: Daily session from first therapy session until moment of return to play, up to an average of Six Weeks
|
The Electromyogram (EMG) is collected at 1000 Hz with MyoTrace™ 400 .
Is a versatile portable handheld, Self-adhesive silver chloride dual snap electrodes for surface attachment will be placed on the leg muscles.
The MyoTrace 400 handheld transmitter.
|
Daily session from first therapy session until moment of return to play, up to an average of Six Weeks
|
|
Degree of pain
Time Frame: Daily session from first therapy session until moment of return to play, up to an average of Six Weeks
|
Pain visual analog scale (VAS).
It is a unidimensional measure of hamstrings pain intensity that consists of a straight horizontal line of fixed length (typically 100 mm) that is graduated.
The ends, which were towards the direction of left (worse) to right (best), defined the extreme boundaries of the parameter to be calculated (pain); the higher the score, the more severe the suffering.
|
Daily session from first therapy session until moment of return to play, up to an average of Six Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kamal H Abdulridha, PhD/Studet, Universidad de Zaragoza
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 21, 2024
Primary Completion (Actual)
May 30, 2024
Study Completion (Actual)
May 30, 2024
Study Registration Dates
First Submitted
November 23, 2023
First Submitted That Met QC Criteria
December 9, 2023
First Posted (Actual)
December 11, 2023
Study Record Updates
Last Update Posted (Actual)
June 3, 2024
Last Update Submitted That Met QC Criteria
May 30, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Injured Hamstring Muscles
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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