NCT06165783

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

March 21, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

June 3, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

November 23, 2023

Last Update Submit

May 30, 2024

Conditions

Keywords

Therapeutic exercises, Hamstring muscle injuries, TUSTherapeutic exercisesHamstring muscle injuriesTUS

Outcome Measures

Primary Outcomes (1)

  • Time to return to play

    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 Outcomes (3)

  • Hamstring muscle strength

    Daily session from first therapy session until moment of return to play, up to an average of Six Weeks

  • Muscle bio potential signals

    Daily session from first therapy session until moment of return to play, up to an average of Six Weeks

  • Degree of pain

    Daily session from first therapy session until moment of return to play, up to an average of Six Weeks

Study Arms (2)

evaluate the effect of using therapeutic exercises and ultrasound

EXPERIMENTAL

evaluate the effect of using therapeutic exercises and ultrasound for the rehabilitation of partially injured hamstring muscles.

Other: Therapeutic Exercises and Ultrasound

analyse its effectiveness on the speedy healing

EXPERIMENTAL

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.

Other: Therapeutic Exercises and Ultrasound

Interventions

describe the rationale and methodology for evaluating the effect of using therapeutic exercises and ultrasound in the rehabilitation of partially injured hamstring muscles

analyse its effectiveness on the speedy healingevaluate the effect of using therapeutic exercises and ultrasound

Eligibility Criteria

Age18 Years - 35 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Baghdad/ college of Physical Education and Sports Sciences

Baghdad, 10070, Iraq

Location

MeSH Terms

Interventions

Exercise TherapyHigh-Energy Shock Waves

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesUltrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Kamal H Abdulridha, PhD/Studet

    Universidad de Zaragoza

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 23, 2023

First Posted

December 11, 2023

Study Start

March 21, 2024

Primary Completion

May 30, 2024

Study Completion

May 30, 2024

Last Updated

June 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations