Development of a tool to measure User-satisfaction with Game-based Treatment in Stroke

Phase 3

Recruiting

• Conditions: Cerebral infarction due to thrombosis of cerebral arteries, (2) ICD-10 Condition: I639||Cerebral infarction, unspecified,

• Registration Number: CTRI/2021/09/036139
• Lead Sponsor: G Shivani

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-09
• Last Update Posted: 2022-03-17

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• (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).

Exclusion Criteria

Aphasic stroke patient.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validation of the Patient Reported Outcome Measure	1 time

Trial Locations

Locations (1)

Kasturba Hospital,Manipal; 🇮🇳 Udupi, KARNATAKA, India

Kasturba Hospital,Manipal

🇮🇳Udupi, KARNATAKA, India

G Shivani

Principal investigator

8106456772

shivani.gollamudi@learner.manipal.edu