Knee OsteoarthritisNCT05590663
FAST and PSFS: Assessment and Validation of Two Functional Scales in Patients With Knee OA in Singapore
An observational study of Knee Osteoarthritis, run by SingHealth Polyclinics at 1 site in Singapore.
Trial summary
The new National One-Rehab framework mandates the use of the Patient-Specific Functional Scale (PSFS) as an outcome measure to track patients' rehabilitation progress. Anecdotally, we have encountered patients (especially elderly ≥ 65 years old) with difficulty understanding and completing such questionnaire… Read more about this study
- Who is it for?
- Ages 45 to 100 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Physiotherapy
- How many people
- 150 participants
- Where
- 1 siteSingapore
- Study dates
- 13 Feb 2023to 15 Sep 2023
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- 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
Study population: Patients with knee osteoarthritis
Who may be able to join
- individuals above the age of 45
- proficient in colloquial/conversational English
- diagnosed with knee osteoarthritis.
Who cannot join
- additional underlying medical or trauma conditions of the knees (e.g., trauma, fracture, infection, inflammatory disease, tumour)
- history of knee surgery within the last three months
- clinically recognizable cognitive impairment that inhibits the completion of the questionnaires.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Activity Scoring Tool (FAST) and Patient-Specific Functional Scale (PSFS): Assessment and Validation of Two Functional Scales in Patients With Knee Osteoarthritis (OA) in Singapore
The new National One-Rehab framework mandates the use of the Patient-Specific Functional Scale (PSFS) as an outcome measure to track patients' rehabilitation progress. Anecdotally, we have encountered patients (especially elderly ≥ 65 years old) with difficulty understanding and completing such questionnaire accurately. We developed a pictorial functional scale (Functional Activity Scoring Tool, FAST) with reference to the successful application of the Wong-Baker FACES pain rating scale. Concurrently, we hope to validate PSFS and FAST against Knee injury and Osteoarthritis Outcome Score (KOOS) which is validated in Singapore population.
This study aims to investigate the reliability and validity of the PSFS and FAST in patients with knee osteoarthritis. We hypothesize that both the PSFS and FAST can be used to measure difficulty in performing activities of daily living in patients with knee osteoarthritis in a reliable and valid manner.
Read more
The FAST and PSFS questionnaires will be administered to patients in SingHealth Polyclinics with knee osteoarthritis to explore the psychometric and clinimetric properties. Eligibility criteria were: age 45 and above, proficient in English, diagnosed with knee osteoarthritis. Patients were excluded if they have underlying medical or trauma conditions (i.e., trauma, fracture, infection, inflammatory disease, tumor), history of knee surgery within the last 3 months, or clinically recognizable cognitive impairment.
Eligible patients will be informed about the purpose of the study and the confidentiality and anonymity of the process. After giving written consent they will complete a questionnaire on demographic and clinical characteristics and the sets of outcome measures (FAST, KOOS, PSFS). Participants will then return at two-to-three weeks later to complete the sets of outcome measures again and GROC, and to state their preferred outcome measures. Statistical analysis will be conducted to evaluate the validity and reliability of PSFS and FAST against KOOS.
Read the detailed description
Validation
The FAST and PSFS questionnaires will be administered to patients in SingHealth Polyclinics (SHP) with knee osteoarthritis to explore the psychometric and clinimetric properties. Eligibility criteria were: age 45 and above, proficient in English, diagnosed with knee osteoarthritis. Patients were excluded if they have underlying medical or trauma conditions (i.e., trauma, fracture, infection, inflammatory disease, tumor), history of knee surgery within the last 3 months, or clinically recognizable cognitive impairment. Statistical analysis will be conducted to evaluate the validity and reliability of PSFS and FAST against KOOS.
Questionnaire
- FAST FAST is developed by Mr. Tang Zhi Yin and Mr. Ng Khim Siong from SHP physiotherapy department. It is a pictorial scale with 7 emotion faces (different degrees of sadness to happiness) on stairs to depict corresponding level of difficulty a patient is experiencing during performing activity. Short descriptions are labelled under the faces, as well as a scale of 0-10 to guide the patient to rate his/her functional difficulty. The patient is asked to identify up to 3 activities that being affected due to his/her current musculoskeletal pain, and to rate each activity on the FAST.
- PSFS The PSFS is a self-reported, patient-specific measure that assesses patients' functional status. Patients are asked to identify three activities that are most affected by their condition and then rate their ability on a 0-10 scale, where 0 is unable to perform activity and 10 is able to perform activity at the same level as before the onset of symptoms.
- KOOS The KOOS is a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. It is a validated tool in Singapore for knee osteoarthritis patients. It has a total of 42 items in 5 subscales i.e., pain, other symptoms, function in daily living, function in sport and recreation, and knee-related quality of life. Scores are interpreted independently for each subscale. As our study focuses on function, we only apply subscales for function in daily living, function in sport and recreation, and knee-related quality of life.
- GROC
The GROC is an outcome measure that assesses patients' self-perception of change in their condition between sessions. Participants were asked to rate the change in their condition on a 15-point transitional scale from -7 (a very great deal worse) to 7 (a very great deal better). The GROC scale is easy to administer, requires minimal skills or training, has good reproducibility, and is sensitive to change.
Data collection
Eligible patients will be informed for the purpose of the study and the confidentiality and anonymity of the process. After giving written consent they will complete a questionnaire on demographic and clinical characteristics and the sets of outcome measures (FAST, KOOS, PSFS). Participants will then return at two-to-three weeks later to complete the sets of outcome measures again and GROC, and to state their preferred outcome measures.
Statistical analysis
All statistical analysis will be conducted using SPSS 26 for Windows. To investigate validity, the discriminant validity was evaluated by the Spearman correlation coefficient according to the following criteria: high (rho ≥ 0.60); moderate (rho < 0.60 - ≥ 0.30); or low (rho <0.30). To analyze the test-retest reliability, the intraclass correlation coefficient (ICC) is calculated. An ICC value of less than 0.40 indicated poor reliability, whereas values between 0.40 and 0.75 indicated fair to good reliability; an ICC value of greater than 0.75 showed excellent reliability.
- Conditions
- Knee Osteoarthritis
- Being tested
- Physiotherapy
- Keywords
- Knee injury and Osteoarthritis Outcome Score, Patient-Specific Functional Scale, Functional Activity Scoring Tool, Functional assessment
- Medical subject headings
- Osteoarthritis, Knee, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
routine referral-based physiotherapy treatment for patients with knee osteoarthritis
| Study group | Role | What they receive |
|---|---|---|
| Patients with knee osteoarthritis | Individuals who are medically diagnosed with knee osteoarthritis and eligible for physiotherapy care in SingHealth Polyclinics will be recruited. Inclusion criteria include: individuals above the age of 45, proficient in colloquial/conversational English, and diagnosed with knee osteoarthritis. Exclusion criteria include additional underlying medical or trauma conditions of the knees (e.g., trauma, fracture, infection, inflammatory disease, tumour), history of knee surgery within the last three months, or clinically recognizable cognitive impairment that inhibits the completion of the questionnaires. Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in functional status as assessed by Functional Activity Scoring Tool (FAST)
Change in functional status as assessed by FAST using a points system
Measured: 3 weeks from baseline examination
Change in functional status as assessed by Patient-Specific Functional Scale (PSFS)
Change in functional status as assessed by PSFS using a points system
Measured: 3 weeks from baseline examination
Change in functional status as assessed by Knee injury and Osteoarthritis Outcome Score (KOOS)
Change in functional status as assessed by KOOS using a points system
Measured: 3 weeks from baseline examination
Patients' self-perception of change in their knee condition as assessed by Global Rating of Change Score (GROC)
Patients' self-perception of change in their knee condition as assessed by GROC using a points system
Measured: 3 weeks from baseline examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start13 Feb 2023
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- SingHealth Polyclinics
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Zhi Yin Tang, Principal investigator, SingHealth Polyclinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590663
- Sponsor's protocol ID
- 202206-00049
- Status last verified
- Jun 2025
- First submitted
- 18 Oct 2022
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that will be shared include: * Demographics data * Outcome data for primary and secondary endpoints
Publications
Stratford P, Gill C, Westaway M, Binkley J. Assessing disability and change on individual patients: a report of a patient specific measure. Physiotherapy Canada. 1995;47(4):258-63.
Chatman AB, Hyams SP, Neel JM, Binkley JM, Stratford PW, Schomberg A, Stabler M. The Patient-Specific Functional Scale: measurement properties in patients with knee dysfunction. Phys Ther. 1997 Aug;77(8):820-9. doi: 10.1093/ptj/77.8.820.
PubMed 9256870Xie F, Li SC, Roos EM, Fong KY, Lo NN, Yeo SJ, Yang KY, Yeo W, Chong HC, Thumboo J. Cross-cultural adaptation and validation of Singapore English and Chinese versions of the Knee injury and Osteoarthritis Outcome Score (KOOS) in Asians with knee osteoarthritis in Singapore. Osteoarthritis Cartilage. 2006 Nov;14(11):1098-103. doi: 10.1016/j.joca.2006.05.005. Epub 2006 Jun 30.
PubMed 16814575Tang ZY, Ng KS, Tee JX, Lee EZE, Bistamam MHB, Wong JS, Koh YLE, Yeung M. Validation of the Functional Activity Scoring Tool (FAST): a novel pictorial scale for assessing function in patients with knee osteoarthritis in primary care. BMJ Open. 2025 Aug 31;15(8):e100732. doi: 10.1136/bmjopen-2025-100732.
PubMed 40887119Tang ZY, Ng KS, Koh YLE, Yeung MT. Study protocol for the validation of a new pictorial functional scale in patients with knee osteoarthritis: the functional activity scoring tool (FAST). BMJ Open. 2024 Jan 8;14(1):e076947. doi: 10.1136/bmjopen-2023-076947.
PubMed 38191249
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Activity Scoring Tool (FAST) and Patient-Specific Functional Scale (PSFS): Assessment and Validation of Two Functional Scales in Patients With Knee Osteoarthritis (OA) in Singapore
- ClinicalTrials.gov ID
- NCT05590663
- Acronym / sponsor ID
- 202206-00049
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee injury and Osteoarthritis Outcome Score, Patient-Specific Functional Scale, Functional Activity Scoring Tool, Functional assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- SingHealth PolyclinicsUniversity, hospital or other
- Collaborators
- Singapore Institute of Technology
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 21 Oct 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.
The new National One-Rehab framework mandates the use of the Patient-Specific Functional Scale (PSFS) as an outcome measure to track patients' rehabilitation progress. Anecdotally, we have encountered patients (especially elderly ≥ 65 years old) with difficulty understanding and completing such questionnaire accurately. We developed a pictorial functional scale (Functional Activity Scoring Tool, FAST) with reference to the successful application of the Wong-Baker FACES pain rating scale. Concurrently, we hope to validate PSFS and FAST against Knee injury and Osteoarthritis Outcome Score (KOOS) which is validated in Singapore population.
This study aims to investigate the reliability and validity of the PSFS and FAST in patients with knee osteoarthritis. We hypothesize that both the PSFS and FAST can be used to measure difficulty in performing activities of daily living in patients with knee osteoarthritis in a reliable and valid manner.
The FAST and PSFS questionnaires will be administered to patients in SingHealth Polyclinics with knee osteoarthritis to explore the psychometric and clinimetric properties. Eligibility criteria were: age 45 and above, proficient in English, diagnosed with knee osteoarthritis. Patients were excluded if they have underlying medical or trauma conditions (i.e., trauma, fracture, infection, inflammatory disease, tumor), history of knee surgery within the last 3 months, or clinically recognizable cognitive impairment.
Eligible patients will be informed about the purpose of the study and the confidentiality and anonymity of the process. After giving written consent they will complete a questionnaire on demographic and clinical characteristics and the sets of outcome measures (FAST, KOOS, PSFS). Participants will then return at two-to-three weeks later to complete the sets of outcome measures again and GROC, and to state their preferred outcome measures. Statistical analysis will be conducted to evaluate the validity and reliability of PSFS and FAST against KOOS.
Detailed description
Validation
The FAST and PSFS questionnaires will be administered to patients in SingHealth Polyclinics (SHP) with knee osteoarthritis to explore the psychometric and clinimetric properties. Eligibility criteria were: age 45 and above, proficient in English, diagnosed with knee osteoarthritis. Patients were excluded if they have underlying medical or trauma conditions (i.e., trauma, fracture, infection, inflammatory disease, tumor), history of knee surgery within the last 3 months, or clinically recognizable cognitive impairment. Statistical analysis will be conducted to evaluate the validity and reliability of PSFS and FAST against KOOS.
Questionnaire
- FAST FAST is developed by Mr. Tang Zhi Yin and Mr. Ng Khim Siong from SHP physiotherapy department. It is a pictorial scale with 7 emotion faces (different degrees of sadness to happiness) on stairs to depict corresponding level of difficulty a patient is experiencing during performing activity. Short descriptions are labelled under the faces, as well as a scale of 0-10 to guide the patient to rate his/her functional difficulty. The patient is asked to identify up to 3 activities that being affected due to his/her current musculoskeletal pain, and to rate each activity on the FAST.
- PSFS The PSFS is a self-reported, patient-specific measure that assesses patients' functional status. Patients are asked to identify three activities that are most affected by their condition and then rate their ability on a 0-10 scale, where 0 is unable to perform activity and 10 is able to perform activity at the same level as before the onset of symptoms.
- KOOS The KOOS is a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. It is a validated tool in Singapore for knee osteoarthritis patients. It has a total of 42 items in 5 subscales i.e., pain, other symptoms, function in daily living, function in sport and recreation, and knee-related quality of life. Scores are interpreted independently for each subscale. As our study focuses on function, we only apply subscales for function in daily living, function in sport and recreation, and knee-related quality of life.
- GROC
The GROC is an outcome measure that assesses patients' self-perception of change in their condition between sessions. Participants were asked to rate the change in their condition on a 15-point transitional scale from -7 (a very great deal worse) to 7 (a very great deal better). The GROC scale is easy to administer, requires minimal skills or training, has good reproducibility, and is sensitive to change.
Data collection
Eligible patients will be informed for the purpose of the study and the confidentiality and anonymity of the process. After giving written consent they will complete a questionnaire on demographic and clinical characteristics and the sets of outcome measures (FAST, KOOS, PSFS). Participants will then return at two-to-three weeks later to complete the sets of outcome measures again and GROC, and to state their preferred outcome measures.
Statistical analysis
All statistical analysis will be conducted using SPSS 26 for Windows. To investigate validity, the discriminant validity was evaluated by the Spearman correlation coefficient according to the following criteria: high (rho ≥ 0.60); moderate (rho < 0.60 - ≥ 0.30); or low (rho <0.30). To analyze the test-retest reliability, the intraclass correlation coefficient (ICC) is calculated. An ICC value of less than 0.40 indicated poor reliability, whereas values between 0.40 and 0.75 indicated fair to good reliability; an ICC value of greater than 0.75 showed excellent reliability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with knee osteoarthritis | – | Other: PhysiotherapyIndividuals who are medically diagnosed with knee osteoarthritis and eligible for physiotherapy care in SingHealth Polyclinics will be recruited. Inclusion criteria include: individuals above the age of 45, proficient in colloquial/conversational English, and diagnosed with knee osteoarthritis. Exclusion criteria include additional underlying medical or trauma conditions of the knees (e.g., trauma, fracture, infection, inflammatory disease, tumour), history of knee surgery within the last three months, or clinically recognizable cognitive impairment that inhibits the completion of the questionnaires. |
Who may qualify
- Ages
- 45 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with knee osteoarthritis
Key inclusion criteria (3 listed)
- individuals above the age of 45
- proficient in colloquial/conversational English
- diagnosed with knee osteoarthritis.
Key exclusion criteria (3 listed)
- additional underlying medical or trauma conditions of the knees (e.g., trauma, fracture, infection, inflammatory disease, tumour)
- history of knee surgery within the last three months
- clinically recognizable cognitive impairment that inhibits the completion of the questionnaires.
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 |
|---|---|---|
| Physiotherapyroutine referral-based physiotherapy treatment for patients with knee osteoarthritis | Other | Patients with knee osteoarthritis |
Primary outcome
Change in functional status as assessed by Functional Activity Scoring Tool (FAST)
Time frame: 3 weeks from baseline examination
Change in functional status as assessed by FAST using a points system
Change in functional status as assessed by Patient-Specific Functional Scale (PSFS)
Time frame: 3 weeks from baseline examination
Change in functional status as assessed by PSFS using a points system
Change in functional status as assessed by Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 3 weeks from baseline examination
Change in functional status as assessed by KOOS using a points system
Patients' self-perception of change in their knee condition as assessed by Global Rating of Change Score (GROC)
Time frame: 3 weeks from baseline examination
Patients' self-perception of change in their knee condition as assessed by GROC using a points system
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 26 Jun 2025.
- BackgroundStratford P, Gill C, Westaway M, Binkley J. Assessing disability and change on individual patients: a report of a patient specific measure. Physiotherapy Canada. 1995;47(4):258-63.
- Background: PubMed 9256870Chatman AB, Hyams SP, Neel JM, Binkley JM, Stratford PW, Schomberg A, Stabler M. The Patient-Specific Functional Scale: measurement properties in patients with knee dysfunction. Phys Ther. 1997 Aug;77(8):820-9. doi: 10.1093/ptj/77.8.820.
- Background: PubMed 16814575Xie F, Li SC, Roos EM, Fong KY, Lo NN, Yeo SJ, Yang KY, Yeo W, Chong HC, Thumboo J. Cross-cultural adaptation and validation of Singapore English and Chinese versions of the Knee injury and Osteoarthritis Outcome Score (KOOS) in Asians with knee osteoarthritis in Singapore. Osteoarthritis Cartilage. 2006 Nov;14(11):1098-103. doi: 10.1016/j.joca.2006.05.005. Epub 2006 Jun 30.
- Derived from this study: PubMed 40887119Tang ZY, Ng KS, Tee JX, Lee EZE, Bistamam MHB, Wong JS, Koh YLE, Yeung M. Validation of the Functional Activity Scoring Tool (FAST): a novel pictorial scale for assessing function in patients with knee osteoarthritis in primary care. BMJ Open. 2025 Aug 31;15(8):e100732. doi: 10.1136/bmjopen-2025-100732.
- Derived from this study: PubMed 38191249Tang ZY, Ng KS, Koh YLE, Yeung MT. Study protocol for the validation of a new pictorial functional scale in patients with knee osteoarthritis: the functional activity scoring tool (FAST). BMJ Open. 2024 Jan 8;14(1):e076947. doi: 10.1136/bmjopen-2023-076947.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that will be shared include: * Demographics data * Outcome data for primary and secondary endpoints
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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.
Zhi Yin Tang principal investigator
SingHealth Polyclinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by SingHealth Polyclinics 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 3 inclusion and 3 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 26 Jun 2025. 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?
Change in functional status as assessed by Functional Activity Scoring Tool (FAST) (time frame: 3 weeks from baseline examination). 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?
On the ClinicalTrials.gov record for NCT05590663, which also lists 5 linked publications.
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 26 Jun 2025.