Total Knee ReplacementNCT05434767
Evaluating the Feasibility and Effectiveness of Using a Smartphone Application During Rehabilitation in Patients After Total Knee Replacement
A study testing Mobile application and Standard rehabilitation program in people with Total Knee Replacement and Total Knee Arthroplasty, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
Despite best efforts to provide standardized and effective rehabilitation sessions post-total knee replacement (TKR), there are a few factors that may result in sub-optimal recovery in this group of patients. Read more about this study
- Who is it for?
- Ages 45 to 100 years
- Conditions the study is for
- Total Knee Replacement, Total Knee Arthroplasty
- What is being tested?
- Mobile application and Standard rehabilitation program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- 29 Jun 2022to 20 Nov 2023
- 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 45 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary unilateral total knee replacement
- Age >= 45 years
- Under the Enhanced Recovery After Surgery (ERAS) programme (discharge on post-operative day 0/1)
- Willingness to be randomized to either mobile application group or standard hospital-based rehabilitation group
- Ability to provide informed consent
- Is technologically savvy - at least 6 months' experience using a smartphone and able to key in data into a smartphone
- English-speaking
Who cannot join
- Rheumatoid arthritis and other systemic arthritis
- A previous history of stroke and other major neurological conditions
- An intention to transfer to step-down care facilities post-operatively or intention to continue outpatient physiotherapy service at another institution
- Unable to perform 5 repetitions of inner-range quadriceps exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Feasibility and Effectiveness of Using a Smartphone Application During Rehabilitation in Patients After Total Knee Replacement: A Pilot Feasibility Randomized Controlled Trial
Despite best efforts to provide standardized and effective rehabilitation sessions post-total knee replacement (TKR), there are a few factors that may result in sub-optimal recovery in this group of patients. There is a need to develop innovative rehabilitation strategies that (i) provide patients with accurate cues allowing for better compliance and exercise performance, (ii) allow for therapists to ensure continuity of care, monitor compliance, and identify deviation from recovery trajectories post-discharge, prior to their first outpatient appointment, and (iii) reduce reliance on manpower and variability during rehabilitation sessions.
Technological solutions that empower patients and allow home-based rehabilitation to take place without the need for real-time human supervision could be the key to improving effectiveness and lowering costs. A mobile application which detects key landmarks on the body for human pose estimation will allow patients to perform their rehabilitation exercises with real-time feedback allowing for proper execution of the exercises. Physiotherapists will be able to access the data generated from the exercise session via a command centre to monitor patients' recovery progress and compliance.
The primary aim of this pilot study is to evaluate the feasibility of using a mobile application during rehabilitation in patients after a TKR surgery. The secondary aim is to study the effects of using a mobile application during rehabilitation on knee functional status, exercise self-efficacy, and treatment satisfaction after TKR surgery.
- Conditions
- Total Knee Replacement, Total Knee Arthroplasty
- Being tested
- Mobile application, Standard rehabilitation program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile applicationDevice
Participants will be instructed on the installation and use of the mobile application on their personal mobile phones. Participants will then have to perform the assigned exercises using the mobile application 3 times daily. Physiotherapists will still perform the required assessment/review, education, and intervention.
Standard rehabilitation programOther
All participants will be seen by physiotherapists in the ward post-TKR surgery and undergo standard inpatient rehabilitation. Patients will be given instructions to perform assigned exercises 3 times daily. Physiotherapists will perform the required assessment/review, education, and intervention.
| Study group | Role | What they receive |
|---|---|---|
| Standard rehabilitation program | Active comparator | Not described Receives: Other: Standard rehabilitation program |
| Mobile application | Experimental | Not described Receives: Device: Mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance
Frequency of exercise sessions completed
Measured: 6 weeks post-surgery
Secondary outcomes (11)
Knee range-of-motion
A long-arm goniometer will be used to measure knee flexion and extension range-of-motion.
Measured: Pre-operation; 6 weeks post-surgery
Gait speed
Usual and fast gait speed
Measured: Pre-operation; 6 weeks post-surgery
Knee Pain
Knee will be measured using separate 11-point numeric pain rating scale, with zero representing no pain at all and 10 representing worst imaginable pain.
Measured: Pre-operation; 6 weeks post-surgery
30 second sit to stand
30 second sit to stand test
Measured: Pre-operation; 6 weeks post-surgery
Self-report physical function
All items are scored on 5-point Likert scales. With100 indicating no symptoms and 0 indicating extreme symptoms.
Measured: Pre-operation; 6 weeks post-surgery
Self-efficacy
Self-efficacy questionnaire
Measured: Pre-operation; 6 weeks post-surgery
Total contact time
Time spent with the patients
Measured: 6 weeks post-surgery
Quality of the mobile application
Quality of the mobile application questionnaire. All items are scored on 5-point Likert scales with 1 indicating "Inadequate" and 5 indicating "Excellent".
Measured: 6 weeks post-surgery
Participant satisfaction
Participants will rate their satisfaction with treatment on an 11-point Likert scale, with 0 indicating "no satisfaction" and 10 indicating "complete satisfaction".
Measured: 6 weeks post-surgery
Treatment credibility
Participants will rate their confidence about the benefits of the intervention on an 11-point Likert scale, with 0 indicating "not confident" and 10 indicating "extremely confident".
Measured: 6 weeks post-surgery
Perceived usefulness and ease of use
Participants will rate their perceived usefulness and ease of use of the intervention on an 11-point Likert scale, with 0 indicating "not useful or not easy" and 10 indicating "extremely useful or extremely easy".
Measured: 6 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start29 Jun 2022
- Primary completion20 Oct 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434767
- Sponsor's protocol ID
- 2021/2718
- Status last verified
- Dec 2023
- First submitted
- 15 Jun 2022
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility and Effectiveness of Using a Smartphone Application During Rehabilitation in Patients After Total Knee Replacement: A Pilot Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05434767
- Acronym / sponsor ID
- 2021/2718
- Conditions
- Total Knee Replacement, Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 28 Jun 2022 (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.
Despite best efforts to provide standardized and effective rehabilitation sessions post-total knee replacement (TKR), there are a few factors that may result in sub-optimal recovery in this group of patients. There is a need to develop innovative rehabilitation strategies that (i) provide patients with accurate cues allowing for better compliance and exercise performance, (ii) allow for therapists to ensure continuity of care, monitor compliance, and identify deviation from recovery trajectories post-discharge, prior to their first outpatient appointment, and (iii) reduce reliance on manpower and variability during rehabilitation sessions.
Technological solutions that empower patients and allow home-based rehabilitation to take place without the need for real-time human supervision could be the key to improving effectiveness and lowering costs. A mobile application which detects key landmarks on the body for human pose estimation will allow patients to perform their rehabilitation exercises with real-time feedback allowing for proper execution of the exercises. Physiotherapists will be able to access the data generated from the exercise session via a command centre to monitor patients' recovery progress and compliance.
The primary aim of this pilot study is to evaluate the feasibility of using a mobile application during rehabilitation in patients after a TKR surgery. The secondary aim is to study the effects of using a mobile application during rehabilitation on knee functional status, exercise self-efficacy, and treatment satisfaction after TKR surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard rehabilitation program | Active comparator | Other: Standard rehabilitation program |
| Mobile application | Experimental | Device: Mobile application |
Who may qualify
- Ages
- 45 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Primary unilateral total knee replacement
- Age >= 45 years
- Under the Enhanced Recovery After Surgery (ERAS) programme (discharge on post-operative day 0/1)
- Willingness to be randomized to either mobile application group or standard hospital-based rehabilitation group
- Ability to provide informed consent
Key exclusion criteria (4 listed)
- Rheumatoid arthritis and other systemic arthritis
- A previous history of stroke and other major neurological conditions
- An intention to transfer to step-down care facilities post-operatively or intention to continue outpatient physiotherapy service at another institution
- Unable to perform 5 repetitions of inner-range quadriceps exercise
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 |
|---|---|---|
| Mobile applicationParticipants will be instructed on the installation and use of the mobile application on their personal mobile phones. Participants will then have to perform the assigned exercises using the mobile application 3 times daily. Physiotherapists will still perform the required assessment/review, education, and intervention. | Device | Mobile application |
| Standard rehabilitation programAll participants will be seen by physiotherapists in the ward post-TKR surgery and undergo standard inpatient rehabilitation. Patients will be given instructions to perform assigned exercises 3 times daily. Physiotherapists will perform the required assessment/review, education, and intervention. | Other | Standard rehabilitation program |
Primary outcome
Compliance
Time frame: 6 weeks post-surgery
Frequency of exercise sessions completed
11 secondary outcomes
Knee range-of-motion
Time frame: Pre-operation; 6 weeks post-surgery
Gait speed
Time frame: Pre-operation; 6 weeks post-surgery
Knee Pain
Time frame: Pre-operation; 6 weeks post-surgery
30 second sit to stand
Time frame: Pre-operation; 6 weeks post-surgery
Self-report physical function
Time frame: Pre-operation; 6 weeks post-surgery
Self-efficacy
Time frame: Pre-operation; 6 weeks post-surgery
Total contact time
Time frame: 6 weeks post-surgery
Quality of the mobile application
Time frame: 6 weeks post-surgery
Participant satisfaction
Time frame: 6 weeks post-surgery
Treatment credibility
Time frame: 6 weeks post-surgery
Perceived usefulness and ease of use
Time frame: 6 weeks post-surgery
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 21 Dec 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Total Knee Replacement
Enrolling by invitation
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Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
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Exploration of Appropriate BIS Range and Propofol Effect-site Concentration During Total Intravenous Anesthesia With Concomitant Adjuvants.
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Not yet recruitingPhase 2
Nutrition and Swelling
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile application and Standard rehabilitation program in people with Total Knee Replacement and Total Knee Arthroplasty, run by Singapore General 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 7 inclusion and 4 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 21 Dec 2023. 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?
Compliance (time frame: 6 weeks post-surgery). 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 21 Dec 2023.