Experience and Technology Acceptance of Older Adults Towards a Gamified Rehabilitative Device Prototype
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Fun-Knee
Sponsored by
About this trial
This is an interventional other trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Cognitively intact (able to follow 3 step commands), community dwelling adults who are 50 years old and above. Not currently attending physiotherapy for knee pain.
Exclusion Criteria:
- Lower limb skin sensitivity, lower limb sensory impairment, open wounds or broken skin, severe vision or hearing impairment, presence of knee pain above 3/10 on numerical rating scale and being English/ Chinese illiterate.
Sites / Locations
- Tan Tock Seng Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental arm
Arm Description
Device: Fun-Knee Portable and low cost sensors are used in the Smart Knee Sleeve. The sensor system is composed of two inclinometers and one Bluetooth transmitter. Fun Knee™ contains total knee replacement exercises that are gamified and supported on mobile device running on Android or iOS platforms. The mobile apps is able to capture the angle a and position data from the two inclinometers on smart knee sleeve.The free-sized knee sleeve prototypes are purchased and assembled by our collaborating vendor.
Outcomes
Primary Outcome Measures
survey
A survey on their experience and impression of Fun-Knee. Following that, a few open-ended questions
Secondary Outcome Measures
Full Information
NCT ID
NCT04059744
First Posted
August 14, 2019
Last Updated
August 14, 2019
Sponsor
Tan Tock Seng Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04059744
Brief Title
Experience and Technology Acceptance of Older Adults Towards a Gamified Rehabilitative Device Prototype
Official Title
Experience and Technology Acceptance of Older Adults Towards a Gamified Rehabilitative Device Prototype
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tan Tock Seng Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Title: Older adults' experience and acceptance of a 'gamified' rehabilitative device for Total Knee Arthroplasty Background: Total Knee Arthroplasty (TKA) is a common surgical procedure. Good post-operative rehabilitation is needed for successful functional recovery. Patients in our institution demonstrated reduced exercise compliance and accuracy during early post-operative rehabilitation. Root cause analysis identified 'reduced feedback', 'reduced care continuity' and 'lack of engagement' to be key contributing factors. Yet, healthcare resource limitations necessitate new ways of care continuation and patient activation. In response, Fun-Knee™, an app-based innovation was created. Using 'gamification' of rehabilitative exercises, Fun-Knee™ guides and tracks rehabilitation from post-surgery to after hospital discharge, till outpatient physiotherapy review. The experience and opinions of older adults towards such 'gamified' rehabilitative technology is unknown.
Purpose: This feasibility study aims to evaluate and develop Fun-Knee™, a novel, app-based rehabilitation device that 'gamifies' post-TKA exercises to improve exercise compliance, effectiveness, and patient activation. Our prototype of Fun-Knee™ was introduced to two cohorts of healthy older adults. Users' experience with hardware and software components of Fun-Knee™, and their acceptance of Fun-Knee™ for rehabilitation were surveyed. Feedback from the first cohort guided prototype refinement. User experience was re-evaluated in the second cohort.
Methods: Community-dwelling adults with no knee pain, 50 years old and above were recruited if they met inclusion criteria. Participants were introduced to two 'gamified' exercises within Fun-Knee™ with standardised instructions. They were instructed to complete one round of the two games at their own time. Thereafter, a survey consisting of quantitative responses was administered. Statistical analysis were performed using Stata (version 13.1, College Station, TX: StataCorp LP), Fisher's exact tests were performed 2-sided at the 5% significance level. Qualitative feedback was obtained during individual interview. Suggestions for hardware or software refinements to Fun-Knee™ were collated and implemented. The above process was repeated for the second cohort of participants, using the latest version of Fun-Knee™.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Convenience sampling will be used. Participants will be recruited through email.
Participants will be number-coded.Participants will be guided to put on the Fun-Knee sleeve. They will perform 3 repetitions of maximal knee flexion and maximal knee extension. A delegated study team member will teach the participant to use the mobile game application that is preloaded on a provided smartphone. Thereafter, they will be given time to complete two games at their own pace, inside a quiet, conducive room. After their trial use of the Fun-Knee prototype, participants will be asked to complete a survey on their experience and impression of Fun-Knee. Following that, a few open-ended questions will be asked.
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
Device: Fun-Knee Portable and low cost sensors are used in the Smart Knee Sleeve. The sensor system is composed of two inclinometers and one Bluetooth transmitter.
Fun Knee™ contains total knee replacement exercises that are gamified and supported on mobile device running on Android or iOS platforms. The mobile apps is able to capture the angle a and position data from the two inclinometers on smart knee sleeve.The free-sized knee sleeve prototypes are purchased and assembled by our collaborating vendor.
Intervention Type
Device
Intervention Name(s)
Fun-Knee
Intervention Description
Portable and low cost sensors are used in the Smart Knee Sleeve. The sensor system is composed of two inclinometers and one Bluetooth transmitter.
Fun Knee™ contains total knee replacement exercises that are gamified and supported on mobile device running on Android or iOS platforms. The mobile apps is able to capture the angle a and position data from the two inclinometers on smart knee sleeve.The free-sized knee sleeve prototypes are purchased and assembled by our collaborating vendor.
Primary Outcome Measure Information:
Title
survey
Description
A survey on their experience and impression of Fun-Knee. Following that, a few open-ended questions
Time Frame
through study completion, an average of 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Cognitively intact (able to follow 3 step commands), community dwelling adults who are 50 years old and above. Not currently attending physiotherapy for knee pain.
Exclusion Criteria:
Lower limb skin sensitivity, lower limb sensory impairment, open wounds or broken skin, severe vision or hearing impairment, presence of knee pain above 3/10 on numerical rating scale and being English/ Chinese illiterate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eng Chuan Neoh
Organizational Affiliation
Senior Physiotherapist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tan Tock Seng Hospital
City
Singapore
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
No
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Experience and Technology Acceptance of Older Adults Towards a Gamified Rehabilitative Device Prototype
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