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General

Study Overview

Title:

Impact of Clubfoot Treatment on Adolescent Life Outcomes : Evidence from Hope Walks Clinic in Ethiopia

Study is 3ie funded:

No

Study ID:

RIDIE-STUDY-ID-626008acc3ca2

Initial Registration Date:

04/20/2022

Last Update Date:

04/21/2022

Study Status:

Ongoing

Location(s):

Ethiopia

Abstract:

Clubfoot is an inborn three-dimensional deformity of the leg, ankle, and foot. General consensus among the clubfoot community has been reached that treatment of clubfoot should be started as soon as possible. If left untreated, structural defects of the foot and lower leg tissues can cause abnormal positioning of the foot and ankle joints leading to long-lasting functional disability, malformation and discomfort that worsens with age. The Ponseti Method is the most common form of treatment for clubfoot and involves both a casting and brace stage that spans over the course of a few years. This study uses a difference-in-difference identification strategy with household level fixed effects to compare adolescent life outcomes with treated clubfoot to the life outcomes of their nearest-age sibling. Those differences are then compared to the difference between the life outcomes of untreated clubfoot patients and their own nearest-age sibling. This strategy allows for estimation of the impact of being born with clubfoot, as well as receiving treatment through the Ponseti Method. Key outcomes of interest include indicators associated with physical, social, and psychological outcomes. 

Registration Citation:

Categories:

Economic Policy
Health, Nutrition, and Population

Additional Keywords:

Clubfoot, Ponseti Method, Impact Evaluation, Human Capital, Health Economics, Child Health

Secondary ID Number(s):

Principal Investigator(s)

Name of First PI:

Bruce Wydick

Affiliation:

University of San Francisco

Name of Second PI:

Gianna Camacho

Affiliation:

University of San Francisco

Study Sponsor

Study Sponsor Location:

United States

Research Partner

Name of Partner Institution:

Hope Walks

Type of Organization:

NGO-international

Location:

Ethiopia

Intervention

Intervention Overview

Intervention:

The Ponseti Method is regarded globally as the best way to treat strutual deformities associated with clubfoot. The Ponseti Method is a multistep process the first of which is known as the casting stage. In the casting stage the affected foot/feet are placed in a series of corrective casts that span for approximately 8 weeks. The casting stage is then followed by a bracing period in which the affected foot/feet are put into braces that are to be worn for 20-22 hours a day for the next four years of life. In some cases a minimally invasive surgery known as a tenotomy may also be performed in which the achilles tendon is snipped and immediately placed into a cast to allow for greater flexibility and ankle rotation. Medical journals have found the Ponseti Method work most effiiently when started as soon as possible; ideally within 48 hours-1 week after birth.

Findings from this study aim to understand how being born with clubfoot, and receiving subsequent treatment through the Ponseti Method, impacts the physical, social and psychological outcomes of individuals. This study aims to expand knowledge on the benefits of the Ponseti Method of treatment which can be used by the medical community, the economics community as well as the non-profit community. 

Theory of Change:

Approximately 80% of clubfoot cases are occurring in LMICs and the most common form of treatment (Ponseti Method) is recommended to be started as soon as possible. This isn't always possible, most especially in LMICs leading to individuals unnecessarily living with the pain and discomfort of clubfoot for their entire lives. The nonprofit Hope Walks aims to provide inexpensive and easily accessible treatment globally. In an effort to communicate trual causal effects of the Ponseti Method the impact evaluation will look seperately at how physical and mobility outcomes, psychological and faith outcomes as well as social and educational outcomes are impacted due to being born with clubfoot and receiving subsequent treatment. 

Multiple Treatment Arms Evaluated?

No

Implementing Agency

Name of Organization:

Hope Walks

Type of Organization:

NGO (International)

Program Funder

Name of Organization:

Donors of Hope Walks

Type of Organization:

NGO (International)

Intervention Timing

Intervention or Program Started at time of Registration?

Yes

Start Date:

04/05/2022

End Date:

Evaluation Method

Evaluation Method Overview

Primary (or First) Evaluation Method:

Difference in difference/fixed effects

Other (not Listed) Method:

Additional Evaluation Method (If Any):

Other (not Listed) Method:

Method Details

Details of Evaluation Approach:

For the purposes of our study, we will compare adolescent life outcomes with treated clubfoot to the life outcomes of their nearest-age sibling. Those differences are then compared to the difference between the adolescent life outcomes of untreated clubfoot patients and their own nearest-age sibling. This strategy allows for estimation of the impact of being born with clubfoot, as well as receiving treatment through the Ponseti Method. In this case, using a cross-sectional model allows us to have some individuals (i) in a subset of the groups with household fixed effects δj who are treated. The counterfactuals generated with this estimation strategy reference the outcomes of other members of an individual’s group, j that are untreated. Four assumptions are applied to this evaluation to develop a model to estimate these impacts. The first assumption is that the occurrence of any deformity associated with clubfoot is random within a household. Second, receiving treatment for clubfoot is random conditional on household characteristics that are held constant via the household fixed effect. Third, the potential outcomes for clubfoot patients and siblings (conditional or observable) are constant. Four, clubfoot status on one sibling does not affect the potential outcomes of the other sibling.

 

Outcomes (Endpoints):

Primary outcome of interest: Impact on Physical and Mobility outcomes due to being born with clubfoot and receiving subsequent treatment. 

Secondary/Intermediate outcomes of interest:

-Impact on Psychological and Faith outcomes due to being born with clubfoot and receiving subsequent treatment. 

-Impact on Social Inclusion and Prosocial Behavior due to being born with clubfoot and receiving subsequent treatment. 

-Impact on Education/Educational Attainment due to being born with clubfoot and receiving subsequent treatment. 

-Impact on Human Flourishing Index due to being born with clubfoot and receiving subsequent treatment. 

 

Unit of Analysis:

Life Outcomes

Hypotheses:

Primary Hypotheses in Section 1: Hypotheses for Physical and Mobility Outcomes

1 H0/Ha: “No impact/ Positive impact of being born with clubfoot (and subsequent treatment) on the index of overall physical health and well-being.” 

2 H0/Ha: “No impact/Positive impact of being born with clubfoot (and subsequent treatment) on an index of general health and physical independence.” 

3 H0/Ha “No impact/Positive impact of being born with clubfoot (and subsequent treatment) on observed physical appearance.”

4 H0/Ha “No impact/Positive impact of being born with clubfoot (and subsequent treatment) on the occurrence of foot pain.”

5 H0/Ha “No impact/Positive impact of being born with clubfoot (and subsequent treatment) on the ability to walk on the soles of one’s feet.”

6 H0/Ha “No impact/Positive impact of being born with clubfoot (and subsequent treatment) on mobility capabilities based on the Hope Walks mobility scale.”  

Seconary hypotheses can be provided for psychological and faith outcomes, educational and social inclusion 

Unit of Intervention or Assignment:

Number of Clusters in Sample:

N/A

Number of Individuals in Sample:

Minimum of 150 obervations/families in both treated and untreated households

Size of Treatment, Control, or Comparison Subsamples:

Minimum of 150 observations/families in both treated and untreated households

Supplementary Files

Analysis Plan:

PAP_0421_GC.pdf

Change History for Analysis Plan

Changed On	Previous Value
04/21/2022	PAP_0405_GC.pdf

Other Documents:

Data

Outcomes Data

Description:

A survey was designed specifically for this study. The survey is constructed into two main sections. The first section collects informational data for clubfoot patients such as contact information and number of biological children within a household. The second section focuses solely on gathering data on life outcomes and is broken into four sub parts. First being physical and mobility section, second psychological and faith outcomes, third social integration, fourth education.

Data Already Collected?

Yes

Data Previously Used?

No

Data Access:

Restricted -- Access requires a formal approval process

Data Obtained by the Study Researchers?

Data Approval Process:

IRB Approval was granted through two parties. IRB protocol ID #1623 with the project title “Impact of Clubfoot Treatment on Adolescent Life Outcomes: Evidence from HopeWalks Clinic” has been approved by the IRB Chair at the University of San Francisco under the rules for expedited review on 08/27/2021. Cure International IRB Approval: IRB protocol ID: CR/impact/CF/2021 with the project title “A Study on the Impact of Clubfoot and Clubfoot Treatment on the Life Outcomes of Children”

Approval Status:

Yes-obtained approval and have received the data

Treatment Assignment Data

Participation or Assignment Information:

Yes

Description:

Data Obtained by the Study Researchers?

Data Previously Used?

Data Access:

Data Obtained by the Study Researchers?

Data Approval Process:

Approval Status:

Data Analysis

Data Analysis Status:

No

Study Materials

Upload Study Materials:

Registration Category

Registration Category:

Prospective, Category 3: Data for measuring impacts have been obtained/collected by the research team but analysis for this evaluation has not started

Completion

Completion Overview

Intervention Completion Date:

Data Collection Completion Date:

Unit of Analysis:

Clusters in Final Sample:

Total Observations in Final Sample:

Size of Treatment, Control, or Comparison Subsamples:

Findings

Preliminary Report:

Preliminary Report URL:

Summary of Findings:

Paper:

Paper Summary:

Paper Citation:

Data Availability

Data Availability (Primary Data):

Date of Data Availability:

Data URL or Contact:

Access procedure:

Other Materials

Survey:

Survey Instrument Links or Contact:

Program Files:

Program Files Links or Contact:

External Link:

External Link Description:

Description of Changes:

Study Stopped

Date:

Reason: