An observational study in Amputation; Traumatic, Leg, Lower, sponsored by Marmara University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-07-02.
Sponsored by Marmara University · Observational
The aim of this study is to investigate the Reliability and construct validity of the Turkish version of the Prosthesis donning and doffing questionnaire in transtibial amputees.
Knowing that a socket and suspension system should be donned and doffed few times during the day and night, it is important to measure ease of donning and doffing. Effortless donning and doffing does appear to have a posi- tive effect on satisfaction with a prosthesis. The socket and suspension systems require different methods of don and doff, some of which are time-consuming and necessi- tate more hand strength and cognitive effort than others. The pin/lock suspension needs few re-adjustments of residual limb within the socket so that the pin is fully locked distally. The seal-in system, for example, needs a longer period as first the amputee needs to spray either the inner socket or the seals, and then remove the socket valve and push the limb into the socket and put back the valve. Instruments are available to evaluate socket comfort such as the socket comfort score, yet to the authors' knowledge no instrument has been developed that focuses on donning and doffing quality of prosthesis. The clearer the insight into suspension systems, the easier will be the selection for prosthetist.
There are different questionnaires in the fields of prosthetics and orthotics such as Prosthetic Evaluation Questionnaire (PEQ), Trinity Amputation and Prosthesis Experience Scales (TAPES), Orthotic Prosthetic User's Survey (OPUS), Houghton scale of prosthetic use, and Amputee Body Image Scale (ABIS) However, few of these instruments address donning and doffing of prosthesis. There is no questionnaire in Turkish available to evaluate the donning and doffing procedures of suspension systems. Thus, the aim of this study is to investigate the Reliability and construct validity of the Turkish version of the Prosthesis donning and doffing questionnaire in transtibial amputees.
After obtaining permission from the developers of the Prosthesis donning and doffing questionnaire, the Turkish version of the instrument will be developed. For the translation process, established guidelines for patient reported outcome (PRO) instrument translation and include both forward and backward (reverse) translation of instructions, items, and response options by independent translators; review by bilingual experts; reconciliation of translations; and cognitive testing of the translated instruments, as described by Eremenco et al., 2005 or Reeve et al., 2013 were followed.The necessity of performing a cultural adaptation for the use of the Turkish version among Turkish amputees will be assessed. Level of education part of the manuscript is planned to be changed bacause it doesn't fit the education system in Turkey). After discussions between the study investigators and translators, a Turkish version of the Prosthesis donning and doffing questionnaire that corresponded as closely as possible to the original survey will be produced. Each subject will be asked to complete the Turkish version of the Prosthesis donning and doffing questionnaire twice (1-3 days apart). To evaluate the validity of the Turkish version of the Prosthesis donning and doffing questionnaire, the Nottingham Health Profile(NHP), Satisfaction with Prosthesis -SATPRO surveys will be used.
Satisfaction with the prosthesis has the following subscales: aesthetic satisfaction with the prosthesis, weight satisfaction with the prosthesis and functional satisfaction with the prosthesis. The weight satisfaction subscale has just one item, which is answered with a 5-point Likert-type scale, whereas both aesthetic satisfaction and functional satisfaction with prosthesis have five items, each answeredwith a 5-point Likert-type scale.
The Turkish version of Nottingham Health Profile(NHP), a generic quality of life measurement tool, has been showed to be a valid and reliable outcome measurement. For this reason it will be used to analyse the construct validity of the Prosthesis donning and doffing questionnaire. NHP (translated by Küçükdeveci et a.) includes the following six subdomains: energy level, physical activities, pain, sleep, emotional reaction and social isolation. The sum of the scores of each subdomain equals.12 The SATPro is a 15-item questionnaire that measures general satisfaction with a prosthesis. The Turkish version of the questionnaire, developed by Simsek, was used. Each item on the questionnaire is scored between 0 and 3.
112 studies on the registry are indexed under Amputation, Traumatic; 24 are open to participants now.
This study's enrollment of 30 is below the median of 37 across 34 observational studies indexed under Amputation, Traumatic.
Browse Amputation, Traumatic studies →Marmara University is the lead sponsor of 599 studies on the registry; 138 are open to participants now.
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Transtibial amputees aged 18-65 years and using their well fitted prosthesis at least 1 year
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Transtibial amputee, who used prosthesis for at least 1 year and had no cognitive disorders.
Exclusion Criteria:
After translation/retranslation of the Prosthesis donning and doffing questionnaire, transtibial amputees will be asked to complete a quality of life evaluation Nottingham Health Profile-NHP, a satisfaction evaluation Satisfaction with Prosthesis -SATPRO and the Turkish version of the Prosthesis donning and doffing questionnaire twice (1-3 days apart).
Other: Satisfaction with Prosthesis -SATPRO · Other: Nottingham Health Profile-NHP · Other: Prosthesis donning and doffing questionnaire
questionnaire 1
questionnaire 2
questionnaire 3
Prosthesis donning and doffing questionnaire
Satisfaction was measured through Prosthesis donning and doffing questionnaire. The total score may be categorized into "low, moderate, and high" as follows-total score ⩽ 2: low; total score = 3 and 4: moderate; and total score ⩾ 5: high. The higher score may be interpreted as higher quality and satisfaction with the donning and doffing.
Time frame: Day 0
Prosthesis donning and doffing questionnaire
Satisfaction was measured through Prosthesis donning and doffing questionnaire. The total score may be categorized into "low, moderate, and high" as follows-total score ⩽ 2: low; total score = 3 and 4: moderate; and total score ⩾ 5: high. The higher score may be interpreted as higher quality and satisfaction with the donning and doffing.
Time frame: Day 3
Satisfaction with Prosthesis -SATPRO
The questionnaire includes 15 items developed on the basis of the most significant criteria used by the person when selecting a technical aid. Minimum score 0 maximum score 45.
Time frame: Day 0
Satisfaction with Prosthesis -SATPRO
The questionnaire includes 15 items developed on the basis of the most significant criteria used by the person when selecting a technical aid. Minimum score 0-maximum score 45.
Time frame: Day 3
Nottingham Health Profile
The Nottingham Health Profile is intended for primary health care, to provide a brief indication of a patient's perceived emotional, social and physical health problems. The number of questions answered "yes" in each subgroup is divided by the total number of questions in the same subgroup and the result is multiplied by 100. Each subgroup has a value of between 0 and 100, with 100 points being considered the best general QoL for the calculated subgroup and 0 points being considered as the worst QoL for the same subgroup.
Time frame: Day 0
Nottingham Health Profile
The Nottingham Health Profile is intended for primary health care, to provide a brief indication of a patient's perceived emotional, social and physical health problems. The number of questions answered "yes" in each subgroup is divided by the total number of questions in the same subgroup and the result is multiplied by 100. Each subgroup has a value of between 0 and 100, with 100 points being considered the best general QoL for the calculated subgroup and 0 points being considered as the worst QoL for the same subgroup.
Time frame: Day 3
Plan to share: No
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