History of Changes for Study: NCT05982431

Metatarsophalangeal Joint Sprain Kinesiotaping

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Version	A	B	Submitted Date	Changes
1			August 5, 2023	None (earliest Version on record)

Study Identification


Unique Protocol ID:	RHPT/0021/0063
Brief Title:	Metatarsophalangeal Joint Sprain Kinesiotaping
Official Title:	Kinesiology Taping Helps Patients With First Metatarsophalangeal Joint Sprain
Secondary IDs:

Study Status


Record Verification:	August 2023
Overall Status:	Completed
Study Start:	September 10, 2021
Primary Completion:	August 22, 2022 [Actual]
Study Completion:	January 15, 2023 [Actual]

First Submitted:	July 10, 2023
First Submitted that Met QC Criteria:	August 5, 2023
First Posted:	August 8, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	August 5, 2023
Last Update Posted:	August 8, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	Qassim University
Responsible Party:	Principal Investigator Investigator: Maged Basha Official Title: Assistant Professor, College of Medical Rehabilitation, Qassim University Affiliation: Qassim University
Collaborators:	Cairo University Prince Sattam Bin Abdulaziz University

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description

Brief Summary:

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

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.

Conditions


Conditions:	Turf Toe Metatarsophalangeal (Joint) Sprain
Keywords:	turf toe Metatarsophalangeal Sprain functional ability gait parameters kinesiology taping

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Not Applicable
Interventional Study Model:	Parallel Assignment
Number of Arms:	3
Masking:	Single (Outcomes Assessor)
Allocation:	Randomized
Enrollment:	60 [Actual]

Arms and Interventions

Arms	Assigned Interventions
Experimental: exercise group 60-minutes exercise program, three times a week on alternate days for 12 successive weeks.	Traditional physical therapy program 60-minutes exercise program, three times a week on alternate days for 12 successive weeks Other Names: 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.	Traditional physical therapy program 60-minutes exercise program, three times a week on alternate days for 12 successive weeks Other Names: exercise program placebo Kinsio taping One full strip of kinesiology taping tape and one half-length strip were needed for the placebo kinesiology taping application Other Names: 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.	Traditional physical therapy program 60-minutes exercise program, three times a week on alternate days for 12 successive weeks Other Names: exercise program Kinsio taping One full strip of kinesiology taping tape and one half-length strip were needed for the kinesiology taping application Other Names: kinesiology taping

Outcome Measures


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


Minimum Age:	25 Years
Maximum Age:	30 Years
Sex:	All
Gender Based:
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/Locations


Study Officials:	Alshimaa Azab, PhD Principal Investigator Cairo University
Locations:	Saudi Arabia, Riyadh
	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

IPDSharing


Plan to Share IPD:	Yes The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
	Supporting Information: 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.
	URL:

References


Citations:	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. PubMed 23306413
	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. PubMed 21673494
	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. PubMed 29158472
Links:
Available IPD/Information: