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临床试验/CTRI/2021/09/036139
CTRI/2021/09/036139招募中3 期

Development and Validation of Patient Reported Outcome Measure to assess User-satisfaction with Game-based Rehabilitation in Stroke

G Shivani1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年10月9日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Validation of the Patient Reported Outcome Measure

研究概览

简要总结

This study’s objective is to analyse the components of patient’s satisfaction along with the factors that would affect the satisfaction with game-based rehabilitation in stroke population. And to develop and then validate the Patient Reported Outcome Measure (PROM) that would assess the user satisfaction after a Game-based Rehabilitation in Stroke patients. The project if divided into 2 phases, phase 1 would be have a literature review would be conducted to gather all the items in the tools used to assess user-satisfaction in neurological rehabilitation, interview with the patient and questions from an interview guide related to their satisfaction of using game-based rehabilitation and the interview would be audio recorded. The audio would then be transcribed and analyzed, next a focus group discussion would be conducted among experts. A PROM will be drafted (PROM draft 1) based on the results obtained from the literature review, patient interview, focus group discussion. An appropriate scoring system would be decided for the PROM draft 1. The second phase would be the content validation of the PROM by physiotherapist and occupational therapists. The changes suggested by the professionals would be incorporated and a PROM draft 2 followed by pilot study, Patients would be instructed to fill it based on their satisfaction with the game-based rehabilitation. Any difficulties to understand any item would be noted the necessary changes would be made in the final version of the measure.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • (a)Patients :- 1.Patients who are clinically diagnosed with stroke 2.Patients must have undergone game-based rehabilitation intervention for at least five sessions.
  • 3.Patients should understand simple commands (b)Experts included would be physiotherapists; occupational therapists (one-year experience in the field of game-based rehabilitation); game developers and clinical psychologist (experienced with stroke patients).

排除标准

  • Aphasic stroke patient.

结局指标

主要结局

Validation of the Patient Reported Outcome Measure

时间窗: 1 time

次要结局

未报告次要终点

研究者

发起方
G Shivani
申办方类型
Other [self]

研究点 (1)

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