FAST and PSFS: Assessment and Validation of Two Functional Scales in Patients With Knee OA in Singapore

NCT ID: NCT05590663

Last Updated: 2025-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-13

Study Completion Date

2023-09-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

1. 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.
2. 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.
3. 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.
4. 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

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Physiotherapy

Intervention Type OTHER

routine referral-based physiotherapy treatment for patients with knee osteoarthritis

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Physiotherapy

routine referral-based physiotherapy treatment for patients with knee osteoarthritis

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* individuals above the age of 45
* proficient in colloquial/conversational English
* diagnosed with knee osteoarthritis.

Exclusion Criteria

* 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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Singapore Institute of Technology

OTHER

Sponsor Role collaborator

SingHealth Polyclinics

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zhi Yin Tang

Role: PRINCIPAL_INVESTIGATOR

SingHealth Polyclinics

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

SingHealth Polyclinics

Singapore, , Singapore

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Singapore

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 9256870 (View on PubMed)

Xie 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.

Reference Type BACKGROUND
PMID: 16814575 (View on PubMed)

Tang 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.

Reference Type DERIVED
PMID: 40887119 (View on PubMed)

Tang 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.

Reference Type DERIVED
PMID: 38191249 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

202206-00049

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Resistance Training in Knee Osteoarthritis
NCT01099371 UNKNOWN PHASE2/PHASE3