None listed
Conditions
Brief summary
Knee osteoarthritis (OA) is a dominant cause of disability, people suffering from the condition often experience pain, stiffness and limitations in physical function. In Singapore, it was reported as 10% of the prevalence based on self-reported diagnosis of arthritis in the National Health Surveillance Survey 2007. Therapeutic exercise was recommended in various clinical guidelines as a care component of conservative management of Knee OA. However, lack of access to physiotherapy facilities, conflict with daily routines and difficulties in transportation arrangement were reported to barrier patients receiving care. Tele-rehabilitation with wearable monitoring device as a remote approach of rehabilitation was reported to probably address some barriers and produce preliminary results in knee OA management. Therefore, a single-blinded randomized control trial will be conducted to investigate the clinical effect of a wearable device equipped tele-rehabilitation program in managing knee OA condition with comparison to conventional face-to-face care. We hypothesize that the tele-rehabilitation approach provides no inferior effect as conventional physiotherapy in conservative knee osteoarthritis management. Forty-eight participants with OA knee condition referred to physiotherapy service will be allocated into either the tele-rehabilitation group using wearable device (TWG) or the control group with conventional face-to face approach (CG). Both groups will receive a 12-week rehabilitation program with CG having 4 monthly physical visits whereas TWG having 2 bi-monthly physical visits and 2 tele-conferences. Both groups will receive same exercise protocol, and the home exercise compliance will be monitored by exercise log for CG and the wearable device for TWG. The primary outcome measures are numerical pain rating scale, patient-specific functional scale and the symptom subscale of Knee injury and Osteoarthritis Outcome Score. Secondary outcomes include the 30-seconds Chair Stand Test, Timed-Up-and-Go test, and Single-Leg Stance time for balance. A repeated measure ANCOVA will be adopted to compare the treatment outcome difference between the two groups.
Interventions
All participants will be randomized to receive either the conventional face-to-face physiotherapy or a telerehabilitation program with wearable device (rebee, XCLR-8 Technologies Pt. Ltd).
Participants will be asked to attend one baseline outcome measure session (face-to-face), 2 therapy sessions (either conventional face-to-face or telerehabilitation session decided by the group allocation) and post-treatment outcome measure session (face-to-face). All participants will also be contacted for a
All participants will be randomized to receive either the conventional face-to-face physiotherapy or a telerehabilitation program with wearable device (rebee, XCLR-8 Technologies Pt. Ltd). Participants will be asked to attend one baseline outcome measure session (face-to-face), 2 therapy sessions (either conventional face-to-face or telerehabilitation session decided by the group allocation) and post-treatment outcome measure session (face-to-face). All participants will also be contacted for a questionnaire survey (in telecommunication form) 3 months and 6 months after they completed your physiotherapy treatments in the current study protocol. The participation in the study will last 36 weeks. Participants are allocated in the telerehabilitation group, they will be asked to wear the wearable device for 12 weeks (when they are doing the exercises prescribed by their therapists and during telecommunication sessions). Participants in the face-to-face group will need to visit the physiotherapy department 4 times (each visit takes about 45 mins with his/her therapist individually), and participants in the telerehabilitation group will need to visit the physiotherapy department physically 2 times (each visit takes about 45 mins with his/her therapist individually) and 2 telecommunication (each takes about 45 mins with his/her therapist individually) Visit 1 (Week 0): • Baseline assessment, including 1) collection of demographic data in person (age, gender, weight, height, education level, duration of symptom, work nature, and lifestyle; 2) Patient-Specific Functional Scale (PSFS); 3) OA knee symptoms; 4) knee pain score; 5) 30-seconds Chair Stand Test; 6) Timed-Up-and-Go test, and 7) Single-Leg Stance test • Exercise prescription according to the condition • Patient education material and exercise log (designed specifically for this study) will be given to participants who are in the face-to-face group. • The rebee apps will be installed to your smart phone and a wearable device will be issued to participants who are in the telerehabilitation group. Visit 2 (Week 4) and visit 3 (Week 8): • For telerehabilitation group, video conferencing session to review exercises prescribed in last session. • For face-to-face group, physiotherapy session with the therapist to review exercises Visit 4 (Week 12): • Repeat the assessment as listed in visit 1 except the demographic data collection. • The device, rebee (telerehabilitation group) will be collected back. Telephone Communication (Week 24 and Week 36): • Reassess Patient-Specific Functional Scale (PSFS) • Reassess OA knee symptoms • Reassess knee pain score Exercise Program for both groups: -muscle strengthening exercises include knee extension, hip abduction, extension, calf strengthening. All exercises are prescribed to conduct at 10 repetition x 3 sets daily, the application of resistance provided by a resistance band for knee and hip exercises depends on participants' condition. -muscle flexibility exercises include knee extensor, knee/hip flexor and calf stretching. All exercises are prescribed to conduct at 20 seconds on hold x10 daily. -functional exercises include tandem walk (5 meters), sit to stand and single leg stand (20 seconds or as tolerated). All exercises are prescribed to conduct at 10 repetitions x 2 sets daily. The adherence to the exercises program will be monitored by exercises log and data stored in the cloud data base for the participants in the face-to-face group and telerehabilitation group respectively.
Sponsors
Ng Teng Fong General Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator)
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
• age 40-80 years old • with the physiotherapy referral for knee OA conservative management from the orthopedic surgery department • with symptomatic clinical diagnosis of knee osteoarthritis (OA) based on the diagnostic criteria of the American College of Rheumatology(Hochberg et al., 2012)
Exclusion criteria
• pain rated 5 and above on the Numerical Pain Rating Scale (NPRS) • cognitive impairment or altered mental status that limits their ability to exercise or follow instructions • unstable medical conditions, e.g. heart disease, uncontrolled diabetes • having medical contraindication or inability to participate in exercise for more than an hour • residual deficits from previous lower limb arthroplasty • requiring physical assistance for ambulation and wheelchair users are excluded from the study
Outcome results
None listed