NCT04059744

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™.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2019

Completed
Last Updated

August 16, 2019

Status Verified

August 1, 2019

Enrollment Period

3 months

First QC Date

August 14, 2019

Last Update Submit

August 14, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • survey

    A survey on their experience and impression of Fun-Knee. Following that, a few open-ended questions

    through study completion, an average of 3 months

Study Arms (1)

Experimental arm

EXPERIMENTAL

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.

Device: Fun-Knee

Interventions

Fun-KneeDEVICE

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.

Experimental arm

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tan Tock Seng Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Eng Chuan Neoh

    Senior Physiotherapist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Physiotherapist

Study Record Dates

First Submitted

August 14, 2019

First Posted

August 16, 2019

Study Start

March 1, 2018

Primary Completion

May 31, 2018

Study Completion

May 31, 2018

Last Updated

August 16, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations