Experience and Technology Acceptance of Older Adults Towards a Gamified Rehabilitative Device Prototype

August 14, 2019 updated by: Eng Chan Neoh, Tan Tock Seng Hospital

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore
        • Tan Tock Seng Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental arm

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

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tan Tock Seng Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eng Chuan Neoh, Senior Physiotherapist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017/01111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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