Congenital Talipes Equino Varus (CTEV) or Clubfoot is a congenital structural deformity characterised by Hindfoot Equinus, Midfoot cavus and Forefoot adduction. It is one of the leading causes of musculoskeletal birth defects. It is necessary to treat it at the earliest so that the foot position can be corrected without requiring any surgical intervention. Studies on the awareness and attitude of parents of children with CTEV show that there is still a significant amount of social stigma attached to it and the child mostly happens to face social and family neglect. This leads to delayed initiation of treatment of the child which then poses a challenge for the child’s future as well as wears the family members down. Thus, the profile of the relatives of CTEV children newly enrolled is an effective unit of measurement of the consciousness regarding this condition in the society. Parents and family members looking after the child have a major hand in the treatment of Clubfoot as their children have to undergo repeated manipulative and corrective exercises, serial casting, surgical correction and must wear braces for prolonged time periods. This requires high degree of conforming to the treatment prescribed and regular follow up. Ensuring that the patient complies with the prescribed method of treatment will only be present if the caregivers are aware about the need for follow up and have the correct attitude towards treatment of the condition. Thus, this study is aiming to identify the barriers and difficulties faced by the caregivers and to find out their knowledge and attitude towards CTEV and its treatment.

Subjects: Primary Caregivers of children with CTEV

Settings: Patients will be enrolled in study in outpatient and Inpatient Department of PMR, AIIMS, Raebareli. After that they will be evaluated for inclusion and exclusion criteria. Informed consent will be taken.

Eligibility Criteria: 

Inclusion criteria:

-          Primary caregivers of children with CTEV, including their parents or guardian. Primary caregivers, as defined by Oxford Dictionary, includes the person who provides most of the care or guardianship.

-          Age >18 years

-          Caregivers willing to participate in the study.

Exclusion criteria:

-          All individuals who are not living with the child and are not directly involved in the care of the children, irrespective of their relationship with the child having CTEV.

-          Under treatment for any Psychiatric issues.

-          Caregivers not willing to participate in the study.

Procedure: After obtaining consent, demographic data of the caregiver will be noted and details of the child will be filled in worksheet proforma. All caregivers of CTEV children who have willingly agreed to take part in the project will be asked to fill out a questionnaire. This questionnaire has been prepared in English and Hindi so that participants speaking the local vernacular language can understand. Pilot testing was done on the first 10 individuals who did not participate in the project, however were found to be fulfilling the inclusion criteria and the research tool was found to be effective and easy to administer. The questionnaire covers the social demographic profile of the caregivers, perceived causes of clubfoot, awareness and attitude towards treatment and well as difficulties and barriers faced by the caregivers. The data will be recorded in an Excel sheet.

Study design: Cross-sectional

Sample Size calculation

Sample Size:

Based on a study by Alam et al, the percentage of population aware about CTEV and its treatment was 7%. Hence using the formula

Sample size = 4 x P x Q / D2

P (expected proportion) = 7%, Q=100-P=93, D (expected deviation) = 5%

Therefore, sample size = 4x7x93/5x5 = 104

The minimum sample size for this study will be 104 subjects (one subject per patient)

Statistical Analysis:

Statistical analysis of the study will be done as per STROBE guidelines since it is a cross-sectional study. The collected data will be entered in Microsoft Excel and then will be analysed and statistically evaluated using SPSS-PC-25 version.