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Trial registered on ANZCTR


Registration number
ACTRN12625000192482
Ethics application status
Approved
Date submitted
22/11/2024
Date registered
18/02/2025
Date last updated
18/02/2025
Date data sharing statement initially provided
18/02/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of Whole-Body Vibration Training Combined with Conventional Rehabilitation on Pain, Physical Function, and Quality of Life in knee osteoarthritis (KOA)
Scientific title
Effects of whole-body vibration training as adjuncts to conventional rehabilitation on pain, physical function, and quality of life in participants diagnosed with knee osteoarthritis
Secondary ID [1] 313426 0
None
Universal Trial Number (UTN)
JEP-2024-789
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 335800 0
Condition category
Condition code
Physical Medicine / Rehabilitation 332377 332377 0 0
Other physical medicine / rehabilitation
Musculoskeletal 332378 332378 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sixty-two participants with knee osteoarthritis will be randomly assigned to three groups: experimental group 1, experimental group 2, and the control group. Group allocation will be conducted using a computerized random number table. Using the Gymna Fitvibe medical vertical rhythmic trainer. Participants are required to stand on the vibration platform wearing slippers. A handrail is provided at the front for safety, but participants must focus their effort on the lower limbs and avoid relying on the handrail for support. Researcher will carry out this intervention in a safe and quiet treatment area, use direct observation to assess adherence to the intervention.
Experimental group 1 will receive whole-body vibration training with knee flexion at 60 degrees for 20 minutes, followed by conventional rehabilitation for 30 minutes. Experimental group 2 will receive whole-body vibration training with knee flexion at 60 degrees, combined with an elastic band placed in the middle of the thigh and hip abduction, for 20 minutes, followed by conventional rehabilitation for 30 minutes,parameters include a vibration frequency of 35 Hz, amplitude displacement ranging from 4 mm to 6 mm, and a session duration of 20 minutes . The interventions will be performed 2-4 times per week over 8 weeks, for a total of 24 sessions.
Intervention code [1] 330002 0
Rehabilitation
Intervention code [2] 330003 0
Treatment: Devices
Comparator / control treatment
The control group will receive conventional rehabilitation for 30 minutes.
Conventional rehabilitation includes soft tissue release, seated knee extension, straight leg raise training, quadriceps static contraction training, hamstring muscle strength training and balance training.
The interventions will be performed 2-4 times per week over 8 weeks, for a total of 24 sessions.
Control group
Active

Outcomes
Primary outcome [1] 339945 0
Knee Injury and Osteoarthritis Outcome Score (KOOS) KOOS(Symptoms) KOOS(Pain) KOOS(Functional status-daily living activities) KOOS(Functional status-sports and leisure activities) KOOS(Knee related QoL) KOOS(Total)
Timepoint [1] 339945 0
Baseline, eight weeks and one month after intervention
Primary outcome [2] 340151 0
KOOS(Symptoms)
Timepoint [2] 340151 0
Baseline, eight weeks and one month after intervention
Primary outcome [3] 340152 0
KOOS(Pain)
Timepoint [3] 340152 0
Baseline, eight weeks and one month after intervention
Secondary outcome [1] 442018 0
Participant's pain levels assessed by Visual Analog Scale (VAS)
Timepoint [1] 442018 0
Baseline, eight weeks and one month after intervention
Secondary outcome [2] 442019 0
Participant's functional mobility and balance assessed using Time Up and Go Test (TUG) (This will be assessed as a composite outcome)
Timepoint [2] 442019 0
Baseline, eight weeks and one month after intervention
Secondary outcome [3] 442020 0
6-minute walk distance test (6MWD)
Timepoint [3] 442020 0
Baseline, eight weeks and one month after intervention
Secondary outcome [4] 442021 0
Star Excursion Balance Test (SEBT)
Timepoint [4] 442021 0
Baseline, eight weeks and one month after intervention
Secondary outcome [5] 442022 0
Quadriceps muscle(peak torque)
Timepoint [5] 442022 0
Baseline, eight weeks and one month after intervention
Secondary outcome [6] 442024 0
The Short Form 36 Health Survey (SF-36)
Timepoint [6] 442024 0
Baseline, eight weeks and one month after intervention
Secondary outcome [7] 442025 0
Active knee flexion ROM assessed using a standard goniometer
Timepoint [7] 442025 0
Baseline, eight weeks and one month after intervention

Eligibility
Key inclusion criteria
(i) Aged between 38 and 80 years old, (ii) diagnosed with unilateral or bilateral KOA based on the American College of Rheumatology criteria, (iii) categorized as mild-to-moderate KOA according to the Kellgren-Lawrence radiographic classification, and (iv) presented with knee pain; (v) if both knees were affected, the knee with worse symptoms was included in the outcome assessment.
Minimum age
38 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) Recent intra-articular knee injection; less than six months, (ii) any other pathological conditions such as rheumatic disease, hip or knee joint replacements, congenital dysplasia, septic arthritis, ligament or meniscus injury, plica syndrome, and Baker’s cyst, or (iii) those with comorbidities that would prevent participation in the intervention or physical evaluation.

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)
Computerized simple block randomization method
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analyzed using SPSS version 26.0, incorporating both descriptive and inferential statistics. Demographic data will be described using frequencies, means, and medians. Depending on the normality of the data, outcome measures for VAS, ROM, KOOS, TUGT, 6MWDT, SEBT, peak torque and SF-36 (continuous data) will be compared using mixed model ANOVA and Feldman's test. Feldman's test will also be utilized to account for sex and KL categorical status (categorical data). In order to compare intra- and inter-group differences between the two groups at baseline, after the 4-week intervention, and after the 8-week intervention, a two-way repeated measures ANOVA will be used to. The significance level will be set at P < 0.05. Effect sizes between groups will be measured using Cohen's D, with values of 0.2, 0.5, and 0.8 representing small, moderate, and large effects, respectively

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/11/2024
Date of last participant enrolment
Anticipated
31/10/2025
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
62
Accrual to date
3
Final
Recruitment outside Australia
Country [1] 26749 0
China
State/province [1] 26749 0
Shang Hai

Funding & Sponsors
Funding source category [1] 318481 0
Self funded/Unfunded
Name [1] 318481 0
Self-finance by Peng Yan and Mohd Azzuan Ahmad
Country [1] 318481 0
China
Primary sponsor type
Individual
Name
Yan Peng, Department of Physical Therapy, Shanghai YangZhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center), School of Medicine, Tongji University, Shanghai, 201619, China
Address
Country
China
Secondary sponsor category [1] 320751 0
None
Name [1] 320751 0
Address [1] 320751 0
Country [1] 320751 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316540 0
Research Ethics Committee Universiti Kebangsaan Malaysia
Ethics committee address [1] 316540 0
Ethics committee country [1] 316540 0
Malaysia
Date submitted for ethics approval [1] 316540 0
27/07/2024
Approval date [1] 316540 0
13/11/2024
Ethics approval number [1] 316540 0
JEP-2024-789

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138206 0
Dr Mohd Azzuan Ahmad
Address 138206 0
Physiotherapy Programme, Centre for Rehabilitation and Special Needs Studies, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur, 50300, Malaysia
Country 138206 0
Malaysia
Phone 138206 0
+60123297292
Fax 138206 0
Email 138206 0
azzuanahmad@ukm.edu.my
Contact person for public queries
Name 138207 0
Peng Yan
Address 138207 0
Department of Physical Therapy, Shanghai YangZhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center), School of Medicine, Tongji University, Shanghai, 201619, China.
Country 138207 0
China
Phone 138207 0
+8615187038367
Fax 138207 0
Email 138207 0
p137950@siswa.ukm.edu.my
Contact person for scientific queries
Name 138208 0
Mohd Azzuan Ahmad
Address 138208 0
Physiotherapy Programme, Centre for Rehabilitation and Special Needs Studies, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur, 50300, Malaysia
Country 138208 0
Malaysia
Phone 138208 0
+60123297292
Fax 138208 0
Email 138208 0
azzuanahmad@ukm.edu.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.