Investigating the Immediate Effects of Kinesio Taping on Anterior Cruciate Ligament Forces in Athletes AfterACL Reconstruction Using Musculoskeletal Modeling

To investigate the immediate effect of Kinesiotaping on anterior cruciate ligament force in athletes following anterior cruciate ligament reconstruction using musculoskeletal modeling.

A randomized, controlled, two-arm, parallel-group clinical trial with 1:1 allocation, including a 12-participant pilot study. Block randomization with concealed allocation will be used, with blinding of the biomechanical assessor and statistical analyst. The trial is non-pharmacological, with no applicable phase.

The study will be conducted at the orthopedics and physiotherapy clinics of Shahid Beheshti Hospital in Babol and the biomechanics laboratory of Babol University of Medical Sciences. Participants will be randomly assigned to receive either Kinesio Taping or sham taping and will perform movement tests while data from force plates and inertial measurement units are simultaneously recorded. The data will be analyzed using musculoskeletal modeling to estimate anterior cruciate ligament force. The biomechanical assessor and the statistical analyst will be blinded to group allocation.

Inclusion criteria: Male and female athletes aged 18 to 40 years, with a history of unilateral anterior cruciate ligament reconstruction performed at least 6 months previously, regular sports activity, and no significant functional limitation of the lower extremity. Exclusion criteria: A history of previous knee injury or surgery, significant concomitant knee injuries or injuries limiting function, severe knee pain or instability, knee locking or swelling, and neurological or systemic disorders affecting motor function.

Kinesio taping group, Sham taping group

Peak anterior cruciate ligament force during the landing phase, normalized to body weight (N/kg); knee flexion angle at initial contact; peak knee flexion angle; knee valgus/Varus angle; internal/external tibial rotation; peak vertical ground reaction force; knee joint moment

Participants will be randomly allocated to either the mechanical correction Kinesiotaping group or the sham taping group at the individual level, with a 1:1 allocation ratio. A permuted block randomization method with variable block sizes of 4 and 6 will be used to generate the randomization sequence. The randomization sequence will be generated by an independent statistician using random sequence generation software. No stratified or cluster randomization will be used. For allocation concealment, the randomization sequence will be placed in sequentially numbered, opaque, sealed envelopes. The envelopes will be prepared by a researcher independent of the assessment and intervention procedures. After completion of the baseline assessments for each participant, the next sequentially numbered envelope will be opened to determine the participant's group allocation. Thus, group allocation will remain concealed from the assessor and the person performing the baseline assessments until completion of the baseline assessments.

After receiving complete information about the study objectives, procedures, and interventions, participants will be informed that they are taking part in a clinical trial and will receive one of the two taping interventions. However, they will be blinded to the type of intervention they receive (mechanical correction Kinesiotaping or sham taping). To maintain blinding, participants will not be provided with information regarding any potential differences or superiority of either taping method. The assessor responsible for collecting and analyzing the biomechanical data will be blinded to the participants’ group allocation and will not have access to information regarding the intervention group during data processing. In addition, an independent statistical analyst will be blinded to group allocation and will perform the statistical analyses without knowledge of the type of intervention received by the participants. The researcher responsible for group allocation and intervention administration will be aware of the participants’ group assignments but will not participate in the assessment or analysis of the biomechanical data or in the statistical analysis. Group allocation will be performed after completion of the baseline assessments using sequentially numbered, opaque, sealed envelopes. Thus, the biomechanical assessor and statistical analyst will remain blinded to group allocation throughout the outcome assessment and data analysis procedures.

De-identified individual participant data and biomechanical data obtained from the study, including non-identifiable demographic characteristics, primary and secondary outcome data, and processed data related to the movement tasks. Data that could directly or indirectly identify participants, identifying information, and confidential medical information will not be shared with other researchers. Shareable data will be provided only after removal or de-identification of identifying information.

Access to the de-identified data will begin 6 months after publication of the primary study results and will remain available for 5 years from the date of publication of the primary results.

Qualified researchers and members of academic or research institutions with a scientifically justified request may apply for access to the data.

The data may be used only for scientific and research purposes related to the study and following approval of the request. The data must be used in a de-identified manner and may not be used to re-identify participants, for commercial purposes, or for purposes inconsistent with research ethics principles. Applicants must specify the research objective, proposed analyses, and procedures for maintaining data confidentiality in their request.

Applicants may submit data access requests to the principal investigator through the contact information provided in the Iranian Registry of Clinical Trials. The request should include the research objective, the type of data requested, and the proposed method of data use.

Upon receipt of a request, the research purpose, type of data requested, proposed use of the data, and procedures for maintaining data confidentiality will be reviewed. If the request is approved, the relevant data will be de-identified and provided to the applicant after agreement on the terms of data use. Requests will generally be reviewed within 30 business days. The time required to provide the data after approval will depend on the type and volume of data requested.