A study to evaluate patient satisfaction with prosthesis in lower limb amputees : A CROSS SECTIONAL OBSERVATIONAL STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Estimation of patient satisfaction regarding the prosthesis Using TAPES-R
研究概览
简要总结
Patients will be recruited using the recruitment process as shown and after recruitment informed consent form will be given and questionnaire called TAPES(Open access score) regarding the prosthesis will be handed over to patient which will be filled by the patient with the assistance of the investigator, satisfaction of the patient regarding the prosthesis will be calculated with the help of scoring present in the questionnaire. An interdisciplinary group consisting of orthopaedic surgeons, a psychiatrist, a physiotherapist, an orthopaedic technician, a nursing officer and a statistician designed the proforma and modified the questionnaire. The questionnaire was translated from English to Hindi and Punjabi by 3 Experts working at PGIMER and verified according to WHO protocol. Initial translations were performed independently and then discussed for any discrepancies and the questionnaire was back-translated from Punjabi and Hindi to English by a fourth translator. The back-translation was compared with the original English version. The validation of the Hindi and Punjabi version of the score will be done during the course of recruitment once we reach half of the targeted sample size. The additional questions added to the original questionnaire will be validated in a similar manner. The questionnaire will have a score attached to each answer and a total score is calculated for each sub heading denoting the satisfaction related to the prosthesis (questionnaire attached in annexures). HADS will be used for estimating the prevalence of anxiety and depression in the patients.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18 to 70 years, Lower limb amputees using prothesis for mobilisation for at least 6 months.
排除标准
- •Patients using prosthesis less than 6 months, patients not consenting for study, patients having amputation near hip or ankle joint, using prosthesis for less than 8 hours, having bilateral amputation, patient having spinal injury, non ambulatory patient.
结局指标
主要结局
Estimation of patient satisfaction regarding the prosthesis Using TAPES-R
时间窗: 6 Months after prosthesis use
次要结局
- 1. Estimation of patient satisfaction regarding the prosthesis use, using a modified version of TAPES-R in lower limb amputees in terms of physical, psychological and social aspects.(2. To enlist the complications and difficulties encountered while using the prosthesis in these patients.)
研究者
Arjit Bansal
PGIMER(post graduate institute of medical education and research ), Chandigarh