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Metatarsophalangeal Joint Sprain Kinesiotaping

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05982431
Recruitment Status : Completed
First Posted : August 8, 2023
Last Update Posted : August 8, 2023
Sponsor:
Collaborators:
Cairo University
Prince Sattam Bin Abdulaziz University
Information provided by (Responsible Party):
Maged Basha, Qassim University

Study Description
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Brief Summary:
kinesio taping would reduce pain, improve gait performance, and enhance the functional capacity of turf toe patients undergoing physical therapy

Condition or disease Intervention/treatment Phase
Turf Toe Metatarsophalangeal (Joint) Sprain Other: Traditional physical therapy program Other: Kinsio taping Other: placebo Kinsio taping Not Applicable

Detailed Description:
Health practitioners have recently become interested in using kinesiology taping in clinical practice as an alternative to traditional taping and bracing procedures for treating a variety of diseases, including sprain of metatarsophalangeal joint of the big toe. Patients with turf toe can benefit from kinesiology tape because it offers therapeutic support and stability while preserving a normal range of motion.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Kinesiology Taping Helps Patients With First Metatarsophalangeal Joint Sprain
Actual Study Start Date : September 10, 2021
Actual Primary Completion Date : August 22, 2022
Actual Study Completion Date : January 15, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: exercise group
60-minutes exercise program, three times a week on alternate days for 12 successive weeks.
 Other: Traditional physical therapy program
60-minutes exercise program, three times a week on alternate days for 12 successive weeks
Other Name: exercise program
Experimental: placebo kinesiology taping plus exercise group
Kinesiology taping was used, however the strain was zero. Before each exercise session, the tape was changed every two days while the patients were present.
 Other: Traditional physical therapy program
60-minutes exercise program, three times a week on alternate days for 12 successive weeks
Other Name: exercise program

Other: placebo Kinsio taping
One full strip of kinesiology taping tape and one half-length strip were needed for the placebo kinesiology taping application
Other Name: placebo kinesiology taping
Experimental: kinesiology taping plus exercise group
putting no stress on the opposite end and a 50% stretch from the top of the big toe to the heel along the back of the heel. After applying a 50% stretch from the top of the big toe to the second horizontal little strip between the big toe and second toe, place the ends below the toe diagonally with no stress.
 Other: Traditional physical therapy program
60-minutes exercise program, three times a week on alternate days for 12 successive weeks
Other Name: exercise program

Other: Kinsio taping
One full strip of kinesiology taping tape and one half-length strip were needed for the kinesiology taping application
Other Name: kinesiology taping


Outcome Measures
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Primary Outcome Measures :
  1. Pain visual analog scale [ Time Frame: at first week ]
    The degree of the pain was assessed using a 10-cm visual analog scale (VAS), with 0 denoting no pain and 10 denoting the most painful event.

  2. Pain visual analog scale [ Time Frame: after 12 weeks ]
    The degree of the pain was assessed using a 10-cm visual analog scale (VAS), with 0 denoting no pain and 10 denoting the most painful event.

  3. Gait parameters (step length by centimeter). [ Time Frame: at first week ]
    The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.

  4. Gait parameters (step length by centimeter). [ Time Frame: after 12 weeks ]
    The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.

  5. Gait parameters (stride length by meter). [ Time Frame: at first week ]
    The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.

  6. Gait parameters (stride length by meter). [ Time Frame: after 12 weeks ]
    The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.

  7. Gait parameters (cadence by steps per minute). [ Time Frame: at first week ]
    The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.

  8. Gait parameters (cadence by steps per minute). [ Time Frame: after 12 weeks ]
    The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.

  9. Gait parameters (velocity by centimeter per second). [ Time Frame: at first week ]
    The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.

  10. Gait parameters (velocity by centimeter per second). [ Time Frame: after 12 weeks ]
    The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.


Secondary Outcome Measures :
  1. Functional ability assessment [ Time Frame: at first week ]
    Functional ability was assessed using the 6-minute walk test.

  2. Functional ability assessment [ Time Frame: after 12 weeks ]
    Functional ability was assessed using the 6-minute walk test.


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • comprised athletes with 2nd grade turf toe.
  • medically stable.
  • had foot pain for more than a month prior to enrollment.
  • didn't have persistent, incapacitating pain.
  • had a doctor's note approving their decision to stop taking painkillers during the research.

Exclusion Criteria:

  • if they had any surgical intervention before.
  • range of motion limitation in the ankle joint.
  • inability to exercise.
  • systemic disease.
  • any other orthopedic problem at ankle joints.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05982431


Locations
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Saudi Arabia
Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University
Al-Kharj, Riyadh, Saudi Arabia, 11432
King Khalid Hospital
Al-Kharj, Riyadh, Saudi Arabia
Sponsors and Collaborators
Qassim University
Cairo University
Prince Sattam Bin Abdulaziz University
Investigators
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Principal Investigator: Alshimaa Azab, PhD Cairo University
More Information
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Publications:

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Responsible Party: Maged Basha, Assistant Professor, College of Medical Rehabilitation, Qassim University, Qassim University
ClinicalTrials.gov Identifier: NCT05982431    
Other Study ID Numbers: RHPT/0021/0063
First Posted: August 8, 2023    Key Record Dates
Last Update Posted: August 8, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Supporting Materials: Study Protocol
Time Frame: 6 months after publication
Access Criteria: relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maged Basha, Qassim University:
turf toe
Metatarsophalangeal Sprain
functional ability
gait parameters
kinesiology taping
Additional relevant MeSH terms:
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Sprains and Strains
Foot Injuries
Wounds and Injuries
Leg Injuries