Study: Development and Validation of a Prosthesis Donning/Doffing Questionnaire
Prosthetic sockets and suspension systems require different donning and doffing methods, some of which are more time-consuming and require more hand strength and cognitive effort than others. Effortless donning and doffing of a prosthetic device can have a positive effect on a user's satisfaction with his or her prosthesis. A team of researchers has developed a questionnaire to evaluate the ability of people with transtibial amputations to don and doff a prosthesis. The study's authors found that the questionnaire indicated good reliability and repeatability, and, either on its own or combined with other prosthetic evaluations, may help manufacturers, clinicians, and researchers improve the donning and doffing qualities of prostheses.
To begin development, the team conducted a literature review to examine other questionnaires designed for similar purposes. The first draft of the new instrument was developed based on interviews with eight experts, as well as prosthetic device users, to identify a list of important items in donning and doffing lower-limb prostheses. The respondents also suggested items that were not included on the initial list. The final questionnaire was administered to 50 people with transtibial amputations, and a test-retest study was also conducted with 20 people with amputations to assess the repeatability of questionnaire items. The cohort of 50 participants included 70.9 percent men, age 51.9 years (± 13.38 years). Most participants (45) had a unilateral amputation, and most amputations (37) were caused by complications from diabetes.
The final version of the questionnaire consists of a demographic section and a section for donning and doffing issues. Seven questions are designed for donning and doffing, including time for donning the prosthesis (soft liner and socket); time for doffing the prosthesis (socket and soft liner); can the person don/doff in the dark; does the person need any device to facilitate donning the prosthesis; how many times the person needs to don and doff the prosthesis per day; the person's satisfaction with the donning process; and the person's satisfaction with the doffing process. The demographics asked about the hand dexterity level, absence or presence and amount of contracture, and activity level, which were evaluated and logged by a prosthetist. Prosthetists measured the time to don and doff a prosthesis with a standard stopwatch. Satisfaction was measured in two questions through a continuous visual analog scale (zero-100).
According to the study's authors, the questionnaire items show correlation coefficients greater than 0.7, which indicate good reliability and repeatability. Most of the participants had good hand dexterity (80 percent) and could perform all types of grasps. The mean satisfaction scores with donning and doffing were 69.9 and 81.4, respectively. Respondents needed to don and doff the prosthesis 3.44 times per day.
A scoring method was suggested based on the pilot sample, which will require further evaluation to differentiate between more suspension types, according to the study. Based on a seven-point score, the total scores ranged between three and seven. Scores closer to seven may be interpreted as better quality of donning and doffing procedures and higher satisfaction. The researchers suggest that a larger, international, multicenter evaluation be conducted to measure the responsiveness of the scales.
The study was published February 13 in Prosthetics and Orthotics International.