The effect of mirror therapy on kinesiophobia and balance in patients with chronic ankle instability A Randomized clinical trial

To investigate the effect of mirror therapy on kinesiophobia and balance in patients with chronic ankle instability

Approximately thirty patients aged 18 to 45 with CAI, meeting the International Ankle Consortium criteria, were enrolled and randomly assigned to two groups (intervention and control). The intervention will be conducted over four weeks, with three sessions per week (12 sessions in total).

Thirty patients aged 18 to 45 with chronic ankle instability will randomly assigned to two groups (intervention and control). The intervention for both group will be conducted over 4 weeks, with 3 sessions per week. The therapist and assessor are different. The assessor will be blinded to patient allocation. the study will be conducted at the physiotherapy clinic of Shiraz University Medical Sciences.

In this study, approximately 30 patients aged 18 to 45 with chronic ankle instability were enrolled based on the criteria of the International Ankle Consortium. Inclusion required a minimum of 12 months to have elapsed since the initial acute ankle sprain—which had caused pain, inflammation, and a need for rest—and at least 3 months since the most recent acute ankle sprain that had similarly resulted in pain, inflammation, and a need for rest.

Participants are randomly assigned to one of two groups: intervention group (mirror therapy plus a conventional rehabilitation program), or control group (conventional rehabilitation program alone). The treatment for both group will be conducted over four weeks, with three sessions per week.

Primary outcome: • kinesiophobia Secondary outcomes: • Static balance • Dynamic balance • Ankle dorsiflexion range of motion • Ankle pain intensity • Mechanical/functional ankle instability • Lower extremity function

Randomization Sequence Generation (Method Used to Generate the Random Allocation Sequence) Following completion of the baseline assessment and confirmation of eligibility according to the inclusion and exclusion criteria, participants will be randomly allocated to either the intervention group or the control group in a 1:1 ratio. The randomization sequence will be generated by an independent statistician who is not involved in participant recruitment, assessment, or treatment, using SPSS statistical software. To maintain balanced group sizes throughout the study, block randomization with variable block sizes (e.g., 4 and 6 participants) will be used. Randomization will be stratified by the key variables of sex and age to ensure a more balanced distribution of these characteristics between the two groups. Allocation Concealment Mechanism To minimize allocation bias, the randomization sequence will be placed in sequentially numbered, opaque, sealed envelopes (SNOSE). An independent allocation officer, who is not involved in participant assessment, will open the next envelope in numerical order in the presence of the participant and assign the participant to the corresponding study group. Until the envelope is opened, neither the clinical investigators, the outcome assessor, nor the participant will be aware of the assigned group. This procedure ensures adequate allocation concealment and minimizes the risk of selection bias. Implementation The random allocation sequence will be generated by an independent statistician. Eligible participants will be recruited and enrolled into the study by the principal investigator after baseline assessment and confirmation of eligibility criteria. Group assignment will be performed by an independent allocation officer who is not involved in participant recruitment, treatment, or outcome assessment.

Blinding Due to the nature of the intervention (mirror therapy), complete blinding of participants is not feasible. However, the following measures will be implemented to minimize information bias: The outcome assessor will be blinded to participants' group allocation, and no information regarding the type of intervention will be recorded on the data collection forms. Participants will be instructed not to disclose details of their exercise program or the use of mirror therapy during outcome assessments. The statistical analyst will also be blinded, as far as possible, by analyzing coded group data (e.g., Groups A and B) without knowledge of the intervention assigned to each group (blinded data analysis). Accordingly, the study will be conducted as an assessor-blinded randomized controlled trial with blinded statistical data analysis through group coding.