Protocol summary
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Study aim
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Investigation of the performance variables of the musculoskeletal system extracted from biomechanical data in functional activities in women with flat feet before and after the functional fatigue protocol in two kinesiotape and sham tape groups
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Design
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The way of dividing people into two kinesiotape or sham tape groups will be according to block randomization. The sample size is 46. There is no trial phase. A clinical trial with a control group with parallel groups. Bilaterally blind.
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Settings and conduct
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The place of performance is in the research center for the treatment of movement disorders at Tarbiat Modares University. The random arrangement in the group is Kinsiotape and sham tape. The participants and the person responsible for data collection are unaware of the study group allocation. The intervention will be in two sessions, one week apart.
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Participants/Inclusion and exclusion criteria
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Entry conditions: Active non-athletes women suffering from bilateral flat feet
normal body mass index (18.5-24.9)
Age 18-30
Conditions of non-entry: history of any lasting orthopedic or neurological injury
The difference in the actual length of the lower body is more than 1.5 centimeter
Significant congenital malformations
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Intervention groups
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It includes Kinesiotape (intervention) or sham tape (control). The first session will be done in the condition without fatigue in two situations with and without tape and the second session will be done in the condition with fatigue in two situations with and without the jump tape. Our fatigue protocol consists of 5 sets of consecutive lateral jumps.
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Main outcome variables
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Biomechanical variables related to the performance of the musculoskeletal system during functional activities such as jumping and walking
General information
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Reason for update
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Updating to provide accurate and up-to-date information about the study
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20201128049511N4
Registration date:
2022-11-28, 1401/09/07
Registration timing:
prospective
Last update:
2025-04-25, 1404/02/05
Update count:
1
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Registration date
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2022-11-28, 1401/09/07
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-11-21, 1401/08/30
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Expected recruitment end date
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2023-06-20, 1402/03/30
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Actual recruitment start date
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2023-04-25, 1402/02/05
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Actual recruitment end date
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2024-01-24, 1402/11/04
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Trial completion date
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2024-01-24, 1402/11/04
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Scientific title
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Effect of Kinesiotape on the Performance of the Musculoskeletal System in Women with Flexible Flatfeet in Conditions with and without Fatigue
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Public title
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Effect of Elastic Bands on the Human Body Performance in Women with Flatfeet
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Active non-athlete women (light aerobic activity three times a week), suffering from bilateral flexible flatfeet
Normal Body Mass Index (18.5-24.9)
Age 18-30
Exclusion criteria:
History of any lasting orthopedic or neurological damage in the lower limbs and spine
The difference in the actual length of the lower body is more than 1.5 centimeter
Significant congenital malformations in the lower limbs
Body mass index more than 24.9
Pain in the lower limbs or spine during the research period
Obvious deformities such as hallux valgus, genu varus, genu valgum, and internal rotation of the thigh
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Age
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From 18 years old to 30 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
24
Actual sample size reached:
46
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization in this study will be done by the block randomization method. In the first session, people are randomly assigned to either kinesiotape or sham tape groups. The number of blocks will be 4 and 6, and randomly be placed in sealed envelopes. For the random assignment, code 1 for the kinesiotape group and code 0 for the sham tape group are placed in the envelopes. subjects will choose a closed envelope and are placed in the kinesiotape or sham tape group based on the selected code.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In the kinesiotape group, the Kinesiotape, which is an elastic therapeutic tape, is attached to the posterior tibialis muscle, the transverse arch, and the inner longitudinal arch of the foot with a special tension to correct the arch and improve muscle function. For the sham group, a piece of tape is attached to the inside of the ankle, that is, in a place other than the treatment area and without tension. Study participants are not aware of whether they are in the kinesiotape or sham group and are not familiar with the treatment. The engineer responsible for data recording also does not have information about how to stick the Kinesiotape, which is a therapeutic task and is blinded to the people in the two groups.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-08-29, 1401/06/07
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Ethics committee reference number
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IR.MODARES.REC.1401.109
Health conditions studied
1
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Description of health condition studied
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Flexible flatfoot
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ICD-10 code
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M21.4
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ICD-10 code description
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Flat foot [pes planus] (acquired)
Primary outcomes
1
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Description
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Biomechanical variables related to body movement activities such as walking and jumping
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Timepoint
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Before and after the functional fatigue protocol
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Method of measurement
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Force plate device
Secondary outcomes
1
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Description
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Navicular drop value
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Timepoint
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Before and after kinesio tape
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Method of measurement
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Difference between the distance of the navicular tuberosity to the ground in the sitting and standing positions
Intervention groups
1
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Description
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Intervention group: intervention includes kinesiotape. In the first session, after learning how to jump, the subject performs the jump in the condition without tape. Then the tape is attached to the subject and this time the jump is done with the tape. Two situations with and without tape will be randomly selected for people. After a week, the second session will begin. In the second session, the fatigue protocol will be applied randomly in two conditions with and without tape. Our fatigue protocol consists of 5 sets of consecutive jumps, and when the person cannot continue the protocol, it means that the person is tired.
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Category
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Treatment - Other
2
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Description
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For the sham tape group, a kinesiotape piece is used on the inside of the ankle. In the first session, after learning how to jump, the subject performs the jump in the condition without tape. Then the tape is attached to the subject and this time the jump is done with the tape. Two situations with and without tape will be randomly selected for people. After a week, the second session will begin. In the second session, the fatigue protocol will be applied randomly in two conditions with and without tape. Our fatigue protocol consists of 5 sets of consecutive jumps, and when the person cannot continue the protocol, it means that the person is tired.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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University of Tarbiat Modares
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Information about the main outcome can be shared after people are not identified.
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When the data will become available and for how long
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After the results are published, the access phase started six months later
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To whom data/document is available
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Researchers in academic and research organizations will also have access to the data.
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Under which criteria data/document could be used
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to do scientific research
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From where data/document is obtainable
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to do scientific research, Sahar Boozari, Jalal Al Ahmad Highway, Tarbiat Modares University, s.boozari@modares.ac.ir, 00982182885053
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What processes are involved for a request to access data/document
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Send the project plan, and if approved, it will be sent following a complete evaluation of the persons and organizations involved in the project.
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Comments
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