Physical Activity and Adaptive Sports Equipment for Assessment in Quality of Life in Amputees
Informed Consent
California State University, Dominguez Hills
Consent to Act as a Research Subject

Physical Activity and Adaptive Sports Equipment for Assessment in Quality of Life in Amputees

Key Information: You are being invited to participate in a research study. Participation is completely voluntary. The purpose of the study is to investigate if there is a relationship between physical activity and usage of adaptive sports equipment to quality of life in individuals with limb deficiency and/or limb loss/amputation(s). The study will take a total of 15 minutes. Risks and/or discomforts will be as follows: Because of the personal nature of the questions, you may reflect on unpleasant memories. If you begin to be uncomfortable, you may discontinue participation at any time, either temporarily or permanently and it will not affect your relationship with the researcher or California State University, Dominguez Hills. There is no direct benefit to you if you participate in this research. The result of this study may help show the benefits to adaptive sports, activity, and participation which in turn may help encourage expansion of these resources. Before you give your consent to volunteer, it is important that you read the following information and ask as many questions as necessary to be sure that you understand what you will be asked to do.

Investigators:
Primary Investigator:
Julie Werner, PhD, OT-R/L, CHT
Faculty
CSUDH Master’s Program for Orthotics and Prosthetics,
562-735-3300

Co-Investigators:
Daicy Luo, BS
Student
CSUDH Master’s Program for Orthotics and Prosthetics,
916-612-0255

Jennifer Lucarevic, PT, DPT
Faculty
CSUDH Master’s Program for Orthotics and Prosthetics
562-735-3300

Purpose of the Study: The purpose of this study is to investigate if there is a relationship between physical activity and usage of adaptive sports equipment to quality of life for individuals with limb loss/ amputation(s). 150 subjects are to be included in this study. These participants must be able to read and understand English, must be 18 years or older, and present with limb deficiency and/or limb loss/ amputation(s). The surgery date for the first amputation must be at least 6 months ago.

Description of the Study: You will be asked to fill out a questionnaire about your age, income, amputation history, physical activity levels, and the remaining questions will ask you to think about your thoughts and feelings on different aspects of everyday life. The survey should take about 15 minutes.

Risks or Discomforts: There is more than minimal risk to participating in this study. Because of the personal nature of some of the questions that will be included on the questionnaire, you may reflect on unpleasant memories or feelings. If you begin to feel uncomfortable, you may discontinue participation at any time, either temporarily or permanently, and it will not affect your relationship with the researcher or California State University, Dominguez Hills. If you need to seek a resource, please contact Amputee Coalition’s Resource Specialists at 888-267-5669 Ext 1 and/or the National Alliance of Mental Illness HelpLine at 1-800-950-NAMI (6264) or info@nami.org to speak to specialists who can help connect you to services and groups to best support you.

Benefits of the Study: There is no guarantee that you will receive any direct benefits from participating in this study. For the amputee population, there may be a potential benefit to expand and encourage greater access to sports adaptive equipment and for programs and facilities supporting amputees at all activity levels.

Confidentiality: Data obtained from this study will be used only in this study unless otherwise allowed to be shared in other research. All files containing subject information will be password protected and confidentiality will be maintained to the extent allowed by law. Please know that the investigator is a mandated reporter for certain types of information you may share. If you mention suicidal thoughts, intention to seriously harm others or knowledge of child or elder abuse, the investigator will be required to report such information to the appropriate authorities.

Incentives to Participate: Participants will be not be compensated or receive incentives for participating in the study survey.

Voluntary Nature of Participation: Participation in this study is voluntary. Your choice of whether or not to participate will not influence your future relations with California State University, Dominguez Hills. If you decide to participate, you are free to withdraw your consent and to stop your participation at any time without penalty or loss of benefits to which you are entitled.

Questions about the Study: If you have any questions about this study or your rights as a participant, you may call the investigator Daicy Luo, 562-735-3300, or the Institutional Review Board for the Protection of Human Subjects at CSUDH, 310-243-3756.

Your signature below indicates that you have read the information in this document and have had a chance to ask any questions you may have about the study. Your signature also indicates that you agree to be in the study and have been told that you can change your mind and withdraw your consent at any time. You have been given a copy of this consent form. You have been told that by signing this consent form you are not giving up any of your legal rights.
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