Knee ArthropathyNCT06248034
A Pilot Feasibility Study Comparing Smartphone Home-based Rehabilitation Program Against the Usual Hospital and Outpatient Physiotherapy Care on Clinical and Cost Effectiveness for Total Knee Replacement Patients
A study testing Smartphone application with tele-monitoring rehabilitation and Hospital-based rehabilitation program in people with Knee Arthropathy, run by Singapore General Hospital.
Trial summary
Knee osteoarthritis (OA) is a common, chronic, and costly condition whilst total knee replacement (TKR) is a common orthopaedic surgical intervention. In Singapore, after TKR surgery, nearly all patients who are home discharged are referred to hospital-based outpatient rehabilitation. Read more about this study
- Who is it for?
- Ages 45 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Arthropathy
- What is being tested?
- Smartphone application with tele-monitoring rehabilitation and Hospital-based rehabilitation program
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2024to 20 Feb 2025
- 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 95 years
- All sexes
- Healthy volunteers accepted
- 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)
- Able to ambulate independently without an assistive device
- Willingness to be randomized to either smartphone home-based rehabilitation program or outpatient rehabilitation
- Ability to provide informed consent
- Able to operate phone application and use online platform
- Able to read and understand English or Mandarin
Who cannot join
- Rheumatoid arthritis and other systemic arthritis
- Significant back or other non-knee pain
- A previous history of stroke and other major neurological conditions
- An intention to transfer to step-down care facilities post-operatively
Trial locations and contacts
No sites are listed yet.
Shuxian, Eleanor Chew contact
About this study
Official title: A Pilot Feasibility Study Comparing Smartphone Home-based Rehabilitation Program Against the Usual Hospital and Outpatient Physiotherapy Care on Clinical and Cost Effectiveness for Total Knee Replacement Patients.
Knee osteoarthritis (OA) is a common, chronic, and costly condition whilst total knee replacement (TKR) is a common orthopaedic surgical intervention. In Singapore, after TKR surgery, nearly all patients who are home discharged are referred to hospital-based outpatient rehabilitation. Although outpatient rehabilitation attendance is associated with better functional outcomes, access to rehabilitation care is limited as outpatient rehabilitation is costly and inconvenient for patients and their caregivers, resulting in suboptimal adherence.
A smartphone home-based rehabilitation program provides the best access to rehabilitation care and is a potential alternative for the majority of patients who do not require intensive "hands-on" rehabilitation therapy.
The primary aim of this randomized controlled trial is to compare patient functional outcomes and cost-effectiveness of this innovative smartphone home-based exercise program versus that of currently standard, hospital-based outpatient rehabilitation program among post TKR patients in the Department of Physiotherapy, Singapore General Hospital.
Read the detailed description
Thirty patients undergoing TKR for knee OA will be randomly assigned to receive either smartphone home-based rehabilitation program or hospital-based rehabilitation program following surgery for a rehabilitation period of 24 weeks. The primary patient functional outcome will be fast gait speed. Outcomes will be assessed preoperatively, at 12-week and 24-week after surgery by an assessor masked to group allocation.
If shown to be non-inferior to the standard outpatient rehabilitation, smartphone home-based exercise program can be recommended as a cost effective treatment option for patients with TKR.
- Conditions
- Knee Arthropathy
- Being tested
- Smartphone application with tele-monitoring rehabilitation, Hospital-based rehabilitation program
- Keywords
- Knee Arthroplasty;, Orthopedic Procedures;, Outcome Assessments;, Self- Help Devices;, Technology;, Knee: Treatment Outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone application with tele-monitoring rehabilitationDevice
This Smartphone application includes an automated criterion-based progression based on participant's regular recorded self-measurement of knee range-of-motion and five-repetition-sit-to-stand. The rehabilitation program is designed to (i) increase knee range-of-motion, (ii) strengthen lower limb strength, (iii) improve postural balance, and (iv) improve physical function.
Hospital-based rehabilitation programProcedure or surgery
Participants will be provided with the usual preoperative, inpatient physiotherapy and a physiotherapy house visit within the first 2-weeks postoperation. Participants will receive exercises, patient education, manual therapy and other modalities that were prescribed and progressed at the project physiotherapist's discretion.
| Study group | Role | What they receive |
|---|---|---|
| Participants for Smartphone Home-based Rehabilitation Program (N=15) | Experimental | Study participants will be recruited from orthopaedic surgeons in Singapore General Hospital. Study participants will be recruited during their outpatient appointment session at the outpatient orthopaedic specialist clinic pre-admission clinic. Receives: Device: Smartphone application with tele-monitoring rehabilitation |
| Participants for Hospital-based rehabilitation program (N=15) | Experimental | Study participants will be recruited from orthopaedic surgeons in Singapore General Hospital. Study participants will be recruited during their outpatient appointment session at the outpatient orthopaedic specialist clinic pre-admission clinic. Receives: Procedure: Hospital-based rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed:
This provides a performance-based measure of physical function. As participants walk a 10-metre walkway at their usual and fast pace.
Measured: Pre-Operative, Week 12 & Week 24
Secondary outcomes (7)
Physical function:
The physical function will be measured using the subscale of Knee Osteoarthritis Outcome Score (KOOS) and Global Rating Scale, which are designed to evaluate the patient's opinion about their knee and associated problem.
Measured: Pre-Operative, Week 12 & Week 24
Muscle strength:
One-repetition Maximum(1RM) is a measure of the maximal weight a participant can lift with one repetition.
Measured: Pre-Operative, Week 12 & Week 24
Knee pain:
Knee pain intensity while navigating stairs, walking, standing and performing a sit-to-stand will be measured using the 10-point numeric pain rating scales (NPRS).
0 - No pain 10 - Extremely painful
Measured: Pre-Operative, Week 12 & Week 24
Knee range-of-motion:
A long-arm goniometer will be used to measure active-assisted knee flexion and extension range-of-motion with the participants in supine position.
Measured: Pre-Operative, Week 12 & Week 24
Stair climb test:
This assesses the participants' ability to ascend and descend stairs, their lower limb strength, balance and endurance. The timing required for participants to ascend one flight of stairs, turn around and descend the same flight of stairs will be taken. The stair climb test is a measure that is performed as part of standard clinical practice.
Measured: Pre-Operative, Week 12 & Week 24
5-repetition-sit-to-stand test:
A test to assess participants' ability to rise from a chair and return to the sitting position. The time taken for participant to stand up and sit down five times as fast as possible from standard chair (43-47cm) without the use of their hands will be recorded. This test is a measure that is performed as part of standard clinical practice and is also a measure of lower limb strength and dynamic balance.
Measured: Pre-Operative, Week 12 & Week 24
30 seconds-sit-to-stand test:
A test to assess participants' ability to rise from a chair and return to the sitting position within 30seconds from standard chair (43-47cm) without the use of their hands will be recorded.
Measured: Pre-Operative, Week 12 & Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start15 Feb 2024 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion20 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthropathyStudies 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
- Single group
- Model description
- The investigators will perform stratified randomization by surgeons, are evenly distributed between the 2 treatment arms. Arm 1: Smartphone Home-based Rehabilitation Program (N=15); Arm 2: Hospital-based rehabilitation program (N=15).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Rootally AI PTE LTD
- Responsible party
- Principal investigator, Eleanor Chew Shuxian, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248034
- Sponsor's protocol ID
- 2023/2482
- Status last verified
- Jan 2024
- First submitted
- 17 Jan 2024
- Last updated
- 8 Feb 2024
- 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 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Study Comparing Smartphone Home-based Rehabilitation Program Against the Usual Hospital and Outpatient Physiotherapy Care on Clinical and Cost Effectiveness for Total Knee Replacement Patients.
- ClinicalTrials.gov ID
- NCT06248034
- Acronym / sponsor ID
- 2023/2482
- Conditions
- Knee Arthropathy
- Keywords
- Knee Arthroplasty;, Orthopedic Procedures;, Outcome Assessments;, Self- Help Devices;, Technology;, Knee: Treatment Outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Rootally AI PTE LTD
- Study start
- 15 Feb 2024 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 20 Feb 2025 (estimated)
- First posted
- 8 Feb 2024 (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.
Knee osteoarthritis (OA) is a common, chronic, and costly condition whilst total knee replacement (TKR) is a common orthopaedic surgical intervention. In Singapore, after TKR surgery, nearly all patients who are home discharged are referred to hospital-based outpatient rehabilitation. Although outpatient rehabilitation attendance is associated with better functional outcomes, access to rehabilitation care is limited as outpatient rehabilitation is costly and inconvenient for patients and their caregivers, resulting in suboptimal adherence.
A smartphone home-based rehabilitation program provides the best access to rehabilitation care and is a potential alternative for the majority of patients who do not require intensive "hands-on" rehabilitation therapy.
The primary aim of this randomized controlled trial is to compare patient functional outcomes and cost-effectiveness of this innovative smartphone home-based exercise program versus that of currently standard, hospital-based outpatient rehabilitation program among post TKR patients in the Department of Physiotherapy, Singapore General Hospital.
Detailed description
Thirty patients undergoing TKR for knee OA will be randomly assigned to receive either smartphone home-based rehabilitation program or hospital-based rehabilitation program following surgery for a rehabilitation period of 24 weeks. The primary patient functional outcome will be fast gait speed. Outcomes will be assessed preoperatively, at 12-week and 24-week after surgery by an assessor masked to group allocation.
If shown to be non-inferior to the standard outpatient rehabilitation, smartphone home-based exercise program can be recommended as a cost effective treatment option for patients with TKR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The investigators will perform stratified randomization by surgeons, are evenly distributed between the 2 treatment arms. Arm 1: Smartphone Home-based Rehabilitation Program (N=15); Arm 2: Hospital-based rehabilitation program (N=15).
| Arm | Type | Receives |
|---|---|---|
| Participants for Smartphone Home-based Rehabilitation Program (N=15) | Experimental | Device: Smartphone application with tele-monitoring rehabilitationStudy participants will be recruited from orthopaedic surgeons in Singapore General Hospital. Study participants will be recruited during their outpatient appointment session at the outpatient orthopaedic specialist clinic pre-admission clinic. |
| Participants for Hospital-based rehabilitation program (N=15) | Experimental | Procedure: Hospital-based rehabilitation programStudy participants will be recruited from orthopaedic surgeons in Singapore General Hospital. Study participants will be recruited during their outpatient appointment session at the outpatient orthopaedic specialist clinic pre-admission clinic. |
Who may qualify
- Ages
- 45 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Primary unilateral total knee replacement
- Age >= 45 years
- Under the Enhanced Recovery After Surgery (ERAS) programme (discharge on post-operative day 0/1)
- Able to ambulate independently without an assistive device
- Willingness to be randomized to either smartphone home-based rehabilitation program or outpatient rehabilitation
Key exclusion criteria (4 listed)
- Rheumatoid arthritis and other systemic arthritis
- Significant back or other non-knee pain
- A previous history of stroke and other major neurological conditions
- An intention to transfer to step-down care facilities post-operatively
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 |
|---|---|---|
| Smartphone application with tele-monitoring rehabilitationThis Smartphone application includes an automated criterion-based progression based on participant's regular recorded self-measurement of knee range-of-motion and five-repetition-sit-to-stand. The rehabilitation program is designed to (i) increase knee range-of-motion, (ii) strengthen lower limb strength, (iii) improve postural balance, and (iv) improve physical function. | Device | Participants for Smartphone Home-based Rehabilitation Program (N=15) |
| Hospital-based rehabilitation programParticipants will be provided with the usual preoperative, inpatient physiotherapy and a physiotherapy house visit within the first 2-weeks postoperation. Participants will receive exercises, patient education, manual therapy and other modalities that were prescribed and progressed at the project physiotherapist's discretion. | Procedure or surgery | Participants for Hospital-based rehabilitation program (N=15) |
Primary outcome
Gait speed:
Time frame: Pre-Operative, Week 12 & Week 24
This provides a performance-based measure of physical function. As participants walk a 10-metre walkway at their usual and fast pace.
7 secondary outcomes
Physical function:
Time frame: Pre-Operative, Week 12 & Week 24
Muscle strength:
Time frame: Pre-Operative, Week 12 & Week 24
Knee pain:
Time frame: Pre-Operative, Week 12 & Week 24
Knee range-of-motion:
Time frame: Pre-Operative, Week 12 & Week 24
Stair climb test:
Time frame: Pre-Operative, Week 12 & Week 24
5-repetition-sit-to-stand test:
Time frame: Pre-Operative, Week 12 & Week 24
30 seconds-sit-to-stand test:
Time frame: Pre-Operative, Week 12 & Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- 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.
Shuxian, Eleanor Chew contact
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone application with tele-monitoring rehabilitation and Hospital-based rehabilitation program in people with Knee Arthropathy, run by Singapore General Hospital.
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 8 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: status not confirmed, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Shuxian, Eleanor Chew (+65 9188 1404), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait speed: (time frame: Pre-Operative, Week 12 & Week 24). 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 8 Feb 2024.