Formative Evaluation of a Mobile Application Facilitated Self-directed Rehabilitation Programme for Knee Osteoarthritis
Formative Evaluation of a Mobile Application Facilitated Self-Directed Rehabilitation Programme for the Conservative Management of Knee Osteoarthritis
In Singapore, knee osteoarthritis (OA) is a prevalent musculoskeletal condition, reflecting global trends of an aging population and lifestyle factors. With Singapore's rapidly aging population and the rising prevalence of obesity and sedentary lifestyles, knee OA has become increasingly common. According to recent studies, symptomatic OA of the knee affects around one-fifth (~300K) of Singaporeans aged 50 years or older. Individuals with advanced knee OA and severe disability often require a total knee replacement (TKR) surgery. While knee replacement surgery is an effective option for severe knee OA, it is costly and there are risks of complications, and should only be considered when all appropriate non-surgical treatment options have been exhausted. Existing research suggests at least a quarter of knee replacements could have been avoided through more optimal conservative treatments.
Despite established healthcare systems and treatment pathways, studies in several settings report that the majority of patients with OA do not receive appropriate and optimal medical care. In Singapore, several factors such as cost, extended wait times, cultural factors and travel inconvenience pose barriers to accessing physiotherapy services. These factors hinder patients' ability to access care resulting in suboptimal care, poor outcomes, and needless economic burden. Thus, there is a large unmet need for innovative and flexible strategies to deliver effective conservative management and treatment for knee OA widely and at a relatively low cost.
Solutions that empower individuals and allow for self-directed rehabilitation without the need for real-time human supervision could be the key to improve effectiveness, accessibility and reduce the reliance on healthcare manpower. Given the prevalence of mobile phone, mobile applications offer a promising avenue for delivering self-directed rehabilitation programs to adults with knee OA. Previous self-directed rehabilitation programs for patients with knee OA have shown promise, however, the adoption and adherence to these programmes remain low, particularly among older adults who may not be technologically savvy. Developing an application that is tailored to the needs and capabilities of older adults with knee osteoarthritis is crucial to improve engagement and long-term adherence to the programme.
The investigators have previously developed a technology-enabled self-directed rehabilitation program for patients who have undergone TKR for primary knee OA. Subsequently, Managing Osteoarthritis of the knee using Therapist-Technology Optimized Rehabilitation (MO-knee-TOR) - a standalone mobile app to facilitate self-directed rehabilitation and complement a "blended" care approach involving an initial face-to-face session with the physiotherapist was developed. MO-knee-TOR was developed for patients with TKR and subsequently evaluated in 2 pilot randomised controlled trials (RCTs). In one of the RCTs, it was found that self-directed rehabilitation post TKR facilitated using the mobile application improved exercise adherence without compromising safety and clinical outcomes. In this current proposal, MO-knee-TOR is adapted for conservative knee OA management through a single-arm pre-post feasibility study with a nested qualitative component.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Ee Lin Woon
- 전화번호: 81253463
- 이메일: woon.ee.lin@sgh.com.sg
연구 장소
-
-
-
Singapore, 싱가포르
- Singapore General Hospital
-
연락하다:
- Ee Lin Woon
- 전화번호: 81253463
- 이메일: woon.ee.lin@sgh.com.sg
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Meet the National Institute for Health and Care Excellence (NICE) osteoarthritis clinical criteria (7)
- aged 45 years and over
- activity related knee joint pain
- morning stiffness ≤30 min
- History of knee pain on most days for ≥3 months
- Able to give informed consent and to participate fully in the interventions and assessment procedures
- Has a smartphone and be willing to use it during the study.
- Able to share photos/ videos with other phone contacts using smartphone
Exclusion Criteria:
- Patients who meet any of the exclusion criteria mentioned below will be excluded from participation.
- Rheumatoid arthritis and other systemic arthritis
- A previous history of stroke and other major neurological conditions
- An intention to undergo knee joint replacement surgery or have had a knee joint replacement
- Has significant back or other non-knee pain
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 장치 타당성
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Self-directed rehabilitation using the mobile application
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 tasks using the mobile application for 12 weeks
|
Participants will be instructed on the installation and use of the mobile application on their personal mobile phones during their first outpatient physiotherapy session.
Participants will then have to perform the assigned tasks using the mobile application for 12 weeks
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Feasibility
기간: 12 weeks after using the mobile application
|
The feasibility of evaluating the prototype in a larger trial will be assessed using predefined progression criteria including, including recruitment and retention rates, adherence to the program, incidence of adverse events, and improvement in function.
Progression will be guided using thresholds categorized as "proceed," "proceed with protocol amendments," or "significant amendments required" based on the criteria defined for each feasibility domain.
|
12 weeks after using the mobile application
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Gait speed
기간: Pre-intervention; 12 weeks after using the mobile application
|
Gait speed will be measured from walking a distance of 4m at comfortable pace and 9m at fast pace with a 2m acceleration and deceleration zone before and after the timed section of 9m.
|
Pre-intervention; 12 weeks after using the mobile application
|
|
Knee range-of-motion
기간: Pre-intervention; 12 weeks after using the mobile application
|
A long-arm goniometer will be used to measure active-assisted knee flexion and extension range-of-motion with the participants in supine position
|
Pre-intervention; 12 weeks after using the mobile application
|
|
Incidental and planned exercise (IPEQ)
기간: 12 weeks after using the mobile application
|
This is a tool developed to measure physical activity, distinguishing between incidental exercise (activities that are not planned but contribute to overall physical activity, like walking to work or taking the stairs) and planned exercise (deliberate, structured exercise like going to the gym or running)
|
12 weeks after using the mobile application
|
|
Health-related quality of life
기간: Pre-intervention; 12 weeks after using the mobile application
|
The EQ5D-5L is a standardised instrument to measure health related quality of life in cost-effectiveness analysis
|
Pre-intervention; 12 weeks after using the mobile application
|
|
Muscle strength
기간: Pre-intervention; 12 weeks after using the mobile application
|
Isotonic quadriceps strength will be determined using the one-repetition maximum test, which is the maximum load the patient could lift once in good form.
A submaximal warm-up was provided by instructing the patient to perform bilateral knee extension at < 10 kgs.
The range of-motion for the test was set from 90° to 40° of knee flexion to avoid the increased patellofemoral joint stress associated with terminal knee extension
|
Pre-intervention; 12 weeks after using the mobile application
|
|
Handgrip strength test
기간: Pre-intervention; 12 weeks after using the mobile application
|
Participants' grip strength will be measured using Jamar hand dynamometer
|
Pre-intervention; 12 weeks after using the mobile application
|
|
Weight bearing symmetry
기간: Pre-intervention; 12 weeks after using the mobile application
|
This assesses the ability of the participants to weight bear on their limb.
With their feet on 2 portable force plates, participants will stand up from a standard chair, and weight-bearing symmetry is calculated by expressing the peak force produced by the operated leg as a percentage of that produced by the unoperated leg.
|
Pre-intervention; 12 weeks after using the mobile application
|
|
5-repetition-sit-to-stand test
기간: Pre-intervention; 12 weeks after using the mobile application
|
A test to assess participants' ability to rise from a chair and return to the sitting position.
The time taken for participant to stan up and sit down five times as fast as posible 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.
|
Pre-intervention; 12 weeks after using the mobile application
|
|
Physical function
기간: Pre-intervention; 12 weeks after using the mobile application
|
Participants will report their physical function using the Short Modified Arthritis Measure for Function (Short-MAC-F), which assesses difficulty in performing common daily activities related to knee function, including stair negotiation, rising from sitting, walking on a flat surface, getting in and out of a car, and dressing.
Each item is rated on a 5-point Likert scale, where 0 indicates "none" and 4 indicates "extreme" difficulty.
Higher scores indicate greater functional limitation.
|
Pre-intervention; 12 weeks after using the mobile application
|
|
Treatment satisfaction
기간: 12 weeks after using the mobile application
|
Participants will rate their satisfaction with the rehabilitation programme using the prototype on a 11 point Likert scale, with 0 indicating "no satisfaction" and 10 indicating "complete satisfaction".
|
12 weeks after using the mobile application
|
|
Exercise Compliance/Adherence
기간: 12 weeks after using the mobile application
|
Self-reported compliance will be collected by asking participants how many times they completed their exercises.
Compliance will also be determined from the data logs captured by the mobile application.
|
12 weeks after using the mobile application
|
|
Brief Fear of Movement
기간: Pre-intervention; 12 weeks after using the mobile application
|
Participants will report their fear of movement related to knee osteoarthritis using the Brief Fear of Movement Scale (BFOM).
The scale consists of multiple statements assessing beliefs about movement, injury, and pain.
Each item is rated on a 4-point Likert scale, where 1 indicates "strongly disagree" and 4 indicates "strongly agree."
|
Pre-intervention; 12 weeks after using the mobile application
|
|
Psychological distress
기간: Pre-intervention; 12 weeks after using the mobile application
|
Four-dimensional symptom questionnaire (4DSQ) will be used to assess psychological distress, anxiety, depression and
|
Pre-intervention; 12 weeks after using the mobile application
|
|
Perceived Need for Knee Replacement Surgery
기간: Pre-intervention; 12 weeks after using the mobile application
|
Participants will rate how necessary they perceive knee replacement surgery for their condition based on knee symptoms over the past week using an 11-point numeric rating scale from 0 to 10 (allowing increments of 0.5), where 0 indicates "not at all necessary" and 10 indicates "totally necessary."
Participants will also provide a categorical rating of perceived necessity, ranging from "not at all necessary" to "totally necessary."
Higher scores indicate a greater perceived need for knee replacement surgery.
|
Pre-intervention; 12 weeks after using the mobile application
|
|
Pain
기간: Pre-intervention; 12 weeks after using the mobile application
|
Participants will rate their knee pain intensity during specific activities using a Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 indicates "no pain" and 11 indicates "worst imaginable pain."
Higher scores indicate greater pain intensity.
|
Pre-intervention; 12 weeks after using the mobile application
|
|
Participant Experience and Perceptions (Exit Interview)
기간: 12 weeks after using the mobile application
|
Participants will attend an exit interview session at study completion to evaluate their experiences and perceptions of using the mobile application and force platforms for self-directed rehabilitation. Qualitative data will be collected through guided interviews, recorded, and analyzed thematically to assess usability, acceptability, and user experience. Findings from these interviews will be used to inform refinements to optimize the application design and overall user experience. |
12 weeks after using the mobile application
|
|
Physical Function
기간: Pre-intervention; 12 weeks after using the mobile application
|
Participants will provide an overall rating of their knee condition using a global rating scale reflecting their perception of their knee and associated problems.
Higher scores indicate greater perceived severity of impairment.
|
Pre-intervention; 12 weeks after using the mobile application
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Education
기간: Pre-intervention
|
Participants will report their highest level of education attained, categorized into predefined levels (e.g., primary, secondary, tertiary).
|
Pre-intervention
|
|
Race
기간: Pre-intervention
|
Race will be self-reported by participants and categorized into predefined groups (e.g., Chinese, Malay, Indian, Others) based on standard demographic classifications.
|
Pre-intervention
|
|
Co-morbidities
기간: Pre-intervention
|
Co-morbidities will be recorded based on participant self-report and/or medical records, including the presence of chronic conditions such as hypertension, diabetes, cardiovascular disease, and others.
|
Pre-intervention
|
|
Kellgren-Lawrence Grading
기간: Pre-intervention
|
Severity of knee osteoarthritis will be assessed using the Kellgren-Lawrence (K-L) grading scale based on radiographic findings, with grades ranging from 0 (no radiographic features of osteoarthritis) to 4 (severe osteoarthritis).
|
Pre-intervention
|
|
Height
기간: Pre-intervention; 12 weeks after using the mobile application
|
Height (in centimeters) will be measured or self-reported and used to calculate body mass index (BMI) in kg/m².
|
Pre-intervention; 12 weeks after using the mobile application
|
|
Weight
기간: Pre-intervention; 12 weeks after using the mobile application
|
Weight (in kilograms) will be measured or self-reported and used to calculate body mass index (BMI) in kg/m².
|
Pre-intervention; 12 weeks after using the mobile application
|
|
Gender
기간: Pre-intervention; 12 weeks after using the mobile application
|
Gender will be self-reported by participants and categorized as male or female
|
Pre-intervention; 12 weeks after using the mobile application
|
|
Comfort With Technology
기간: Pre-intervention;
|
Participants will report their confidence and frequency of using technology in daily life. Confidence in using technology will be assessed using a 4-point scale, where 0 indicates "not at all confident" and 3 indicates "extremely confident," with higher scores indicating greater confidence. Frequency of technology use will be assessed across a range of common digital tools (e.g., mobile phone, SMS, computer, email, tablet, video conferencing platforms, online shopping, internet use, and social media). Each item will be rated on a 6-point scale ranging from "never" to "every day," with higher scores indicating more frequent use of technology. |
Pre-intervention;
|
|
Knee Osteoarthritis Knowledge Scale
기간: Pre-intervention; 12 weeks after using the mobile application
|
Knowledge of knee osteoarthritis will be assessed using the Knee Osteoarthritis Knowledge Scale, with higher scores indicating greater understanding of the condition, its management, and treatment options.
|
Pre-intervention; 12 weeks after using the mobile application
|
|
E-Health Literacy
기간: Pre-intervention
|
Participants will rate their agreement with statements assessing their ability to find and use online health information using a 5-point Likert scale, where 1 indicates "strongly disagree" and 5 indicates "strongly agree."
Higher scores indicate greater perceived eHealth literacy.
|
Pre-intervention
|
|
Perceived Social Support (Multidimensional Scale of Perceived Social Support - MSPSS, Family Subscale)
기간: Pre-intervention; 12 weeks after using the mobile application
|
Participants will rate their perceived social support from family using the Multidimensional Scale of Perceived Social Support (MSPSS).
Items are rated on a 7-point Likert scale, where 1 indicates "very strongly disagree" and 7 indicates "very strongly agree."
The scale assesses perceived emotional and practical support from family, including help with decision-making, availability of support, and ability to discuss problems.
Higher scores indicate greater perceived social support.
|
Pre-intervention; 12 weeks after using the mobile application
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 2024-4180
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .