- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05982431
Metatarsophalangeal Joint Sprain Kinesiotaping
August 5, 2023 updated by: Maged Basha, Qassim University
Kinesiology Taping Helps Patients With First Metatarsophalangeal Joint Sprain
kinesio taping would reduce pain, improve gait performance, and enhance the functional capacity of turf toe patients undergoing physical therapy
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
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
-
-
Riyadh
-
Al-Kharj, Riyadh, Saudi Arabia
- King Khalid Hospital
-
Al-Kharj, Riyadh, Saudi Arabia, 11432
- Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University
-
-
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:
- 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.
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: exercise group
60-minutes exercise program, three times a week on alternate days for 12 successive weeks.
|
60-minutes exercise program, three times a week on alternate days for 12 successive weeks
Other Names:
|
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.
|
60-minutes exercise program, three times a week on alternate days for 12 successive weeks
Other Names:
One full strip of kinesiology taping tape and one half-length strip were needed for the placebo kinesiology taping application
Other Names:
|
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.
|
60-minutes exercise program, three times a week on alternate days for 12 successive weeks
Other Names:
One full strip of kinesiology taping tape and one half-length strip were needed for the kinesiology taping application
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
at first week
|
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.
|
after 12 weeks
|
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.
|
at first week
|
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.
|
after 12 weeks
|
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.
|
at first week
|
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.
|
after 12 weeks
|
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.
|
at first week
|
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.
|
after 12 weeks
|
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.
|
at first week
|
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.
|
after 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional ability assessment
Time Frame: at first week
|
Functional ability was assessed using the 6-minute walk test.
|
at first week
|
Functional ability assessment
Time Frame: after 12 weeks
|
Functional ability was assessed using the 6-minute walk test.
|
after 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alshimaa Azab, PhD, Cairo University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mostafavifar M, Wertz J, Borchers J. A systematic review of the effectiveness of kinesio taping for musculoskeletal injury. Phys Sportsmed. 2012 Nov;40(4):33-40. doi: 10.3810/psm.2012.11.1986.
- Burr JF, Bredin SS, Faktor MD, Warburton DE. The 6-minute walk test as a predictor of objectively measured aerobic fitness in healthy working-aged adults. Phys Sportsmed. 2011 May;39(2):133-9. doi: 10.3810/psm.2011.05.1904.
- Kim MK, Shin YJ. Immediate Effects of Ankle Balance Taping with Kinesiology Tape for Amateur Soccer Players with Lateral Ankle Sprain: A Randomized Cross-Over Design. Med Sci Monit. 2017 Nov 21;23:5534-5541. doi: 10.12659/msm.905385.
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)
September 10, 2021
Primary Completion (Actual)
August 22, 2022
Study Completion (Actual)
January 15, 2023
Study Registration Dates
First Submitted
July 10, 2023
First Submitted That Met QC Criteria
August 5, 2023
First Posted (Actual)
August 8, 2023
Study Record Updates
Last Update Posted (Actual)
August 8, 2023
Last Update Submitted That Met QC Criteria
August 5, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RHPT/0021/0063
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
IPD Sharing Time Frame
6 months after publication
IPD Sharing Access Criteria
relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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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