Knee OsteoarthritisNCT04059744
Experience and Technology Acceptance of Older Adults Towards a Gamified Rehabilitative Device Prototype
A study testing Fun-Knee in people with Knee Osteoarthritis, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Fun-Knee
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Mar 2018to 31 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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™.
- Conditions
- Knee Osteoarthritis
- Being tested
- Fun-Knee
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Fun-Knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
survey
A survey on their experience and impression of Fun-Knee. Following that, a few open-ended questions
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start1 Mar 2018
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eng Chan Neoh, Tan Tock Seng Hospital
- Investigators
- Eng Chuan Neoh, Principal investigator, Senior Physiotherapist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059744
- Sponsor's protocol ID
- 2017/01111
- Other IDs
- 2017
- Status last verified
- Aug 2019
- First submitted
- 14 Aug 2019
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experience and Technology Acceptance of Older Adults Towards a Gamified Rehabilitative Device Prototype
- ClinicalTrials.gov ID
- NCT04059744
- Acronym / sponsor ID
- 2017/01111
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 16 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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™.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Device: Fun-KneeDevice: 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fun-KneePortable 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 | Experimental arm |
Primary outcome
survey
Time frame: through study completion, an average of 3 months
A survey on their experience and impression of Fun-Knee. Following that, a few open-ended questions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eng Chuan Neoh principal investigator
Senior Physiotherapist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fun-Knee in people with Knee Osteoarthritis, run by Tan Tock Seng Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survey (time frame: through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2019.