Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000200785
Ethics application status
Approved
Date submitted
18/08/2021
Date registered
7/02/2022
Date last updated
21/01/2024
Date data sharing statement initially provided
7/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Technology-assisted Rehabilitation for People with Knee Osteoarthritis: the Impact on patient outcome of a Telerehabilitation Approach with Wearable technology
Scientific title
Technology-assisted Rehabilitation for People with Knee Osteoarthritis: the Impact of a telerehabilitation approach with wearable technology on pain and knee function.
Secondary ID [1] 305084 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 323302 0
Condition category
Condition code
Musculoskeletal 320867 320867 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 321478 0
Treatment: Other
Intervention code [2] 322140 0
Treatment: Devices
Comparator / control treatment
The participants in the control arm will receive 3 monthly face-to-face physiotherapy sessions including the same exercise prescription as the intervention team, and their home exercise compliance will be recorded by a exercise log. There is no telerehabilitation sessions or wearable device given to the participants in the control group.
Control group
Active

Outcomes
Primary outcome [1] 328664 0
Pain measured by Numeric Pain Rating Score
Timepoint [1] 328664 0
Pre-intervention (week 0), Week 12, Week 24 and Week 36 (primary endpoint) post-intervention commencement.
Primary outcome [2] 328665 0
The symptom subscale in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Timepoint [2] 328665 0
Pre-intervention (week 0), Week 12, Week 24 and Week 36 (primary endpoint) post-intervention commencement.
Primary outcome [3] 329487 0
Patient-Specific Functional Scale
Timepoint [3] 329487 0
Pre-intervention (week 0), Week 12, Week 24 and Week 36 (primary endpoint) post-intervention commencement.
Secondary outcome [1] 399871 0
Timed-Up-and-Go (TUG) test,
Timepoint [1] 399871 0
Pre-intervention (week 0), Week 12, post-intervention commencement.
Secondary outcome [2] 399872 0
Single-Leg Stance (SLS) time for balance
Timepoint [2] 399872 0
Pre-intervention (week 0), Week 12, post-intervention commencement.
Secondary outcome [3] 402775 0
30-seconds Chair Stand Test
Timepoint [3] 402775 0
Pre-intervention (week 0), Week 12, post-intervention commencement.

Eligibility
Key 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)
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The targeted sample size was calculated using G*Power 3.1 using a small effect size of 0.20 (Cohen, 1988), desired power of 80%, a of .05, group of 2 for repeated measures ANOVA. The correlation among 4 repeated measures was set as .5. There are no studies in the literature evaluating the impact of wearable device application in telerehabilitation on patient outcome. It was hypothesized that the wearable device component would improve the participants’ condition at least as effective as the conventional face-to-face therapy. Thus, a small effect size of 0.20 was deemed suitable to detect the difference in the outcome measures between the 2 intervention groups. The sample size produced by G*Power 3.1 with the above parameters was 36. We increased another 6 participants for each group to tackle dropouts which is usually estimated at 30% in clinical studies.

A repeated measure ANCOVA will be adopted to compare the treatment outcome difference (PSFS, NPRS, Knee OA symptoms 30s-CST, TUG and SLS) between the 2 groups, and demographic data and exercise compliance will be entered as covariates to examine their impact in the final model. Alpha level was set at .05 for all tests of significance. All statistical analyses were performed using SPSS 19.0 for Windows.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/02/2022
Actual
14/11/2022
Date of last participant enrolment
Anticipated
5/07/2024
Actual
Date of last data collection
Anticipated
5/01/2025
Actual
Sample size
Target
48
Accrual to date
28
Final
Recruitment outside Australia
Country [1] 24051 0
Singapore
State/province [1] 24051 0

Funding & Sponsors
Funding source category [1] 309481 0
Hospital
Name [1] 309481 0
Ng Teng Fong General Hospital
Country [1] 309481 0
Singapore
Primary sponsor type
Hospital
Name
Ng Teng Fong General Hospital
Address
1 Jurong East Street 21, Singapore 609606
Country
Singapore
Secondary sponsor category [1] 310453 0
None
Name [1] 310453 0
None
Address [1] 310453 0
None
Country [1] 310453 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309268 0
National Healthcare Group, Domain Specific Review Board
Ethics committee address [1] 309268 0
3 Fusionalpolis Link
#03-08 Nexus@one-north
Singapore 138543
Ethics committee country [1] 309268 0
Singapore
Date submitted for ethics approval [1] 309268 0
24/09/2020
Approval date [1] 309268 0
22/10/2020
Ethics approval number [1] 309268 0
2020/01061

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113562 0
Dr Cai Congcong
Address 113562 0
Physiotherapy, Rehabilitation Department
Ng Teng Fong General Hospital
1 Jurong East street 21
Singapore 609606
Country 113562 0
Singapore
Phone 113562 0
+6567161670
Fax 113562 0
Email 113562 0
[email protected]
Contact person for public queries
Name 113563 0
Dr Cai Congcong
Address 113563 0
Physiotherapy, Rehabilitation Department
Ng Teng Fong General Hospital
1 Jurong East street 21
Singapore 609606
Country 113563 0
Singapore
Phone 113563 0
+6567161670
Fax 113563 0
Email 113563 0
[email protected]
Contact person for scientific queries
Name 113564 0
Dr Cai Congcong
Address 113564 0
Physiotherapy, Rehabilitation Department
Ng Teng Fong General Hospital
1 Jurong East street 21
Singapore 609606
Country 113564 0
Singapore
Phone 113564 0
+6567161670
Fax 113564 0
Email 113564 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to the restriction and policy from the ethics review board, National Healthcare Group, Domain Specific Review Board, study data, including de-identified individual participant data is not allowed to share with any other parties.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.