NCT05590663

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 21, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

February 13, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

7 months

First QC Date

October 18, 2022

Last Update Submit

June 23, 2025

Conditions

Keywords

Knee injury and Osteoarthritis Outcome ScorePatient-Specific Functional ScaleFunctional Activity Scoring ToolFunctional assessment

Outcome Measures

Primary Outcomes (4)

  • Change in functional status as assessed by Functional Activity Scoring Tool (FAST)

    Change in functional status as assessed by FAST using a points system

    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

    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

    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

    3 weeks from baseline examination

Study Arms (1)

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.

Other: Physiotherapy

Interventions

routine referral-based physiotherapy treatment for patients with knee osteoarthritis

Patients with knee osteoarthritis

Eligibility Criteria

Age45 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with knee osteoarthritis

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SingHealth Polyclinics

Singapore, Singapore

Location

Related Publications (5)

  • 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.

    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.

    PMID: 9256870BACKGROUND
  • 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.

    PMID: 16814575BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

Osteoarthritis, KneeKnee Injuries

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Zhi Yin Tang

    SingHealth Polyclinics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2022

First Posted

October 21, 2022

Study Start

February 13, 2023

Primary Completion

September 15, 2023

Study Completion

September 15, 2023

Last Updated

June 26, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) that will be shared include: * Demographics data * Outcome data for primary and secondary endpoints

Time Frame
IPD will be available beginning 6 months after publication of the primary results and will remain available for 5 years thereafter.
Access Criteria
Data will be made available to qualified researchers upon reasonable request, subject to approval by the sponsor and completion of a data use agreement.

Locations