Arthroplasty, ReplacementNCT04080401
Effectiveness of a Novel Gaming System on Post-operative Rehabilitation Outcomes After Total Knee Arthroplasty
A study testing Game-based rehabilitation exercise and Conventional brochures of rehabilitation exercise in people with Arthroplasty, Replacement and Physical Therapy, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial summary
This study aims to evaluate the effectiveness of a novel, game-based rehabilitation system, consisting a sensor-equipped knee sleeve and a mobile application, on rehabilitation outcomes after Total Knee Arthroplasty (TKA) surgery, when compared to conventional rehabilitation; where patients learn and perform… Read more about this study
- Who is it for?
- Ages 51 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Physical Therapy
- What is being tested?
- Game-based rehabilitation exercise and Conventional brochures of rehabilitation exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jun 2018to Dec 2019
- 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 51 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First, elective, unilateral TKA operation completed in Tan Tock Seng Hospital
- At least two days of inpatient stay
- Discharge to own or carer's home
- Adults >50 years old
- Able to understand and follow instructions consistently
Who cannot join
- Post-operative infections or wound complications
- Cognitive impairment
- Sensitive/ broken, Irritable skin around operative knee
- Previous TKA on same or opposite knee
- Pregnant women
- Pre-existing skin conditions e.g. eczema
- Poor wound status e.g. poor wound closure or condition
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Tan Tock Seng Hospital
Singapore, 308433
Kun Man Li, 96306203, kunman_li@ttsh.com.sg
Eng Chuan Neoh, 91733222, eng_chuan_neoh@ttsh.com.sg
About this study
Official title: Effectiveness of a Novel Gaming System on Post-operative Rehabilitation Outcomes After Total Knee Arthroplasty: A Pilot Study
This study aims to evaluate the effectiveness of a novel, game-based rehabilitation system, consisting a sensor-equipped knee sleeve and a mobile application, on rehabilitation outcomes after Total Knee Arthroplasty (TKA) surgery, when compared to conventional rehabilitation; where patients learn and perform rehabilitative exercises using printed brochures.
Read the detailed description
This is a randomized controlled trial investigating the effectiveness of a novel, game-based rehabilitation system, consisting a sensor-equipped knee sleeve and a mobile application, on rehabilitation outcomes after Total Knee Arthroplasty (TKA).
All patients receiving TKA will be screened for eligibility. Patients who meet inclusion criteria and provide informed consent will be allocated to either intervention or control group using block randomization. A study team member blinded to subject characteristics will allocate subjects to either group.
Subjects in the intervention group will be guided to do their post-TKA rehabilitation exercises using the investigator's game-based system, which includes the wearable sensor device and mobile application games. Subjects in the control group will be guided to do their post-TKA rehabilitation exercises using conventional, paper-based exercise brochures.
From post-operative day 1, all subjects who are medically fit for physiotherapy will receive 2 sessions of physiotherapy, daily; for at least the first 3 post-operative days. The first session consists of individualized physiotherapy that includes bed exercises and ambulation training. In the second session of physiotherapy, subjects will perform their bed exercises using the game-based system or paper-based exercise brochures. Upon discharge, subjects in the intervention group will continue home-based rehabilitation exercises using the game-based system, while those in the control group continue to use the exercise brochures.
- Conditions
- Arthroplasty, Replacement, Physical Therapy
- Being tested
- Game-based rehabilitation exercise, Conventional brochures of rehabilitation exercise
- Keywords
- Rehabilitation, Gaming, Exercise, Knee Arthroplasty
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game-based rehabilitation exerciseDevice
4 games (exercises) on operated limb, for 3 sessions daily, until outpatient physiotherapy review visit.
Conventional brochures of rehabilitation exerciseOther
4 exercises on operated limb, 30 reps each, for 3 sessions daily, until outpatient physiotherapy review visit.
| Study group | Role | What they receive |
|---|---|---|
| Fun-Knee Mobile Application | Experimental | Participants will use a mobile application paired to a knee sleeve with embedded inclinometer sensors. The sensor system will compute knee movement, and feed towards game-based rehabilitation exercises for Total Knee Arthroplasty rehabilitation. game-based and supported on mobile device running on Android or Inter-network Operating System platforms. The mobile apps is able to capture the angle and position data from the two inclinometers on smart knee sleeve. Receives: Device: Game-based rehabilitation exercise |
| Conventional Exercise Brochures | Active comparator | Participants will be guided to do their Total Knee Arthroplasty rehabilitation exercises using conventional, paper-based exercise brochures. Receives: Other: Conventional brochures of rehabilitation exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Visual analogue scale (0-10) for participant-reported pain intensity. Maximum score (10) for worst pain, minimum score (0) for no pain.
Measured: Difference in pain score between hospital discharge and first outpatient physiotherapy review (within 3 weeks post-operation)
Knee flexion range of motion
Passive range of knee bending motion measured by handheld goniometry (ranging from -15 to 150 degrees), measuring angle formed by between femur and fibula.
Measured: Difference in angle between hospital discharge and first outpatient physiotherapy review (within 3 weeks post-operation)
Knee extension range of motion
Passive range of knee straightening measured by handheld goniometry (ranging from -30 to 20 degrees), measuring angle formed by between femur and fibula.
Measured: Difference in angle between hospital discharge and first outpatient physiotherapy review (within 3 weeks post-operation)
Ambulation status
Use of gait aid, assistance during walking in the home or community
Measured: At hospital discharge, at outpatient review (2-3 weeks post-operation), at outpatient discharge or 3 months post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start1 Jun 2018
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, ReplacementStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ng Teng Fong Healthcare Innovation Programme, Nanyang Technological University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080401
- Sponsor's protocol ID
- 2017/00229
- Other IDs
- 2017
- Status last verified
- Sep 2019
- First submitted
- 14 Aug 2019
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Novel Gaming System on Post-operative Rehabilitation Outcomes After Total Knee Arthroplasty: A Pilot Study
- ClinicalTrials.gov ID
- NCT04080401
- Acronym / sponsor ID
- 2017/00229
- Conditions
- Arthroplasty, Replacement, Physical Therapy
- Keywords
- Rehabilitation, Gaming, Exercise, Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Collaborators
- Ng Teng Fong Healthcare Innovation Programme, Nanyang Technological University
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 6 Sep 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.
This study aims to evaluate the effectiveness of a novel, game-based rehabilitation system, consisting a sensor-equipped knee sleeve and a mobile application, on rehabilitation outcomes after Total Knee Arthroplasty (TKA) surgery, when compared to conventional rehabilitation; where patients learn and perform rehabilitative exercises using printed brochures.
Detailed description
This is a randomized controlled trial investigating the effectiveness of a novel, game-based rehabilitation system, consisting a sensor-equipped knee sleeve and a mobile application, on rehabilitation outcomes after Total Knee Arthroplasty (TKA).
All patients receiving TKA will be screened for eligibility. Patients who meet inclusion criteria and provide informed consent will be allocated to either intervention or control group using block randomization. A study team member blinded to subject characteristics will allocate subjects to either group.
Subjects in the intervention group will be guided to do their post-TKA rehabilitation exercises using the investigator's game-based system, which includes the wearable sensor device and mobile application games. Subjects in the control group will be guided to do their post-TKA rehabilitation exercises using conventional, paper-based exercise brochures.
From post-operative day 1, all subjects who are medically fit for physiotherapy will receive 2 sessions of physiotherapy, daily; for at least the first 3 post-operative days. The first session consists of individualized physiotherapy that includes bed exercises and ambulation training. In the second session of physiotherapy, subjects will perform their bed exercises using the game-based system or paper-based exercise brochures. Upon discharge, subjects in the intervention group will continue home-based rehabilitation exercises using the game-based system, while those in the control group continue to use the exercise brochures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fun-Knee Mobile Application | Experimental | Device: Game-based rehabilitation exerciseParticipants will use a mobile application paired to a knee sleeve with embedded inclinometer sensors. The sensor system will compute knee movement, and feed towards game-based rehabilitation exercises for Total Knee Arthroplasty rehabilitation. game-based and supported on mobile device running on Android or Inter-network Operating System platforms. The mobile apps is able to capture the angle and position data from the two inclinometers on smart knee sleeve. |
| Conventional Exercise Brochures | Active comparator | Other: Conventional brochures of rehabilitation exerciseParticipants will be guided to do their Total Knee Arthroplasty rehabilitation exercises using conventional, paper-based exercise brochures. |
Who may qualify
- Ages
- 51 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- First, elective, unilateral TKA operation completed in Tan Tock Seng Hospital
- At least two days of inpatient stay
- Discharge to own or carer's home
- Adults >50 years old
- Able to understand and follow instructions consistently
Key exclusion criteria (7 listed)
- Post-operative infections or wound complications
- Cognitive impairment
- Sensitive/ broken, Irritable skin around operative knee
- Previous TKA on same or opposite knee
- Pregnant women
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 |
|---|---|---|
| Game-based rehabilitation exercise4 games (exercises) on operated limb, for 3 sessions daily, until outpatient physiotherapy review visit. | Device | Fun-Knee Mobile Application |
| Conventional brochures of rehabilitation exercise4 exercises on operated limb, 30 reps each, for 3 sessions daily, until outpatient physiotherapy review visit. | Other | Conventional Exercise Brochures |
Primary outcome
Pain Intensity
Time frame: Difference in pain score between hospital discharge and first outpatient physiotherapy review (within 3 weeks post-operation)
Visual analogue scale (0-10) for participant-reported pain intensity. Maximum score (10) for worst pain, minimum score (0) for no pain.
Knee flexion range of motion
Time frame: Difference in angle between hospital discharge and first outpatient physiotherapy review (within 3 weeks post-operation)
Passive range of knee bending motion measured by handheld goniometry (ranging from -15 to 150 degrees), measuring angle formed by between femur and fibula.
Knee extension range of motion
Time frame: Difference in angle between hospital discharge and first outpatient physiotherapy review (within 3 weeks post-operation)
Passive range of knee straightening measured by handheld goniometry (ranging from -30 to 20 degrees), measuring angle formed by between femur and fibula.
Ambulation status
Time frame: At hospital discharge, at outpatient review (2-3 weeks post-operation), at outpatient discharge or 3 months post-operation
Use of gait aid, assistance during walking in the home or community
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Arthroplasty, Replacement
Enrolling by invitation
Comparison of Functional Results of ADM X3-MoP Cup (Stryker) and a CoC Cup (Zimmer) in Young Patients
Arthroplasties, Hip Replacement
Active, not recruiting
At Home, Digital Rehabilitation for Patients After Reverse Total Shoulder Arthroplasty
Arthroplasty, Replacement, Shoulder, Reverse Total Shoulder Arthroplasty
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
Active, not recruiting
Healthy Living After Knee Replacement
Arthroplasty, Overweight and Obesity
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Game-based rehabilitation exercise and Conventional brochures of rehabilitation exercise in people with Arthroplasty, Replacement and Physical Therapy, 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Difference in pain score between hospital discharge and first outpatient physiotherapy review (within 3 weeks post-operation)). The study lists 4 primary outcomes in all. 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 10 Sep 2019.