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Trial registered on ANZCTR


Registration number
ACTRN12618001739202
Ethics application status
Approved
Date submitted
28/09/2018
Date registered
23/10/2018
Date last updated
22/03/2019
Date data sharing statement initially provided
22/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Use half-cut wood training method for rehabilitation of Chinese patients with knee instability
Scientific title
The effectiveness of half-cut wood training method on rehabilitation of Chinese patients with knee instability
Secondary ID [1] 296202 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
knee instability 309841 0
Condition category
Condition code
Physical Medicine / Rehabilitation 308630 308630 0 0
Other physical medicine / rehabilitation
Musculoskeletal 308631 308631 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Previous studies have shown that if a series of overlapping segments were connected via pin joints, these interlocking joints would create a system that would allow the movement of one joint to affect the movement of another joint within the kinetic chain. This leads to knees and ankles operating in unity. In order to stabilize knees, ankle mobility should therefore be improved. Our study therefore developed Half-wood Training method to reflect these principles. In this method, endways quincuncial piles were cut into half and placed transversely, in order to decrease the risk and the degree of difficulty, allowing for comfortable and convenient barefooted practice for patients with knee instability.

There are four phases of the intervention consisting of four phases with 40 lessons in total and the intervention will take both supervised individual level training plus self-directed exercise and qualified physicians will deliver the intervention program. Each lesson takes 45 minutes: (1). Phase 1: 10 lessons in Education and posture training. This include basic understanding of the function of joints, characteristics of normal and abnormal postures and movements and joint related exercise. This phase will last for 5 days, with 90 minutes supervised training, and 60 minutes self-directed exercise per day. The self-directed exercise is to review and repeat the exercise actions during the supervised training session (2). 10 lessons in Phase 2. This phase will focus on multiple joints' training and respiratory training. The purpose of the exercise is to facilitate coordination of action and respiration by exercise starting from one joint exercise to multiple joint based exercise. This will take 5 days with 90 minutes supervised exercise and 1 hours 30 minutes self-directed exercise time per day. The self-directed exercise is to review and repeat the exercise actions during the supervised training session (3). 10 lessons in Phase 3. This phase will focus on abnormal knee joint and spine training. This phase exercise is to correct abnormal posture and shape of the spine. This willl take 5 days with 90 minutes supervised exercise and 1hours 30 minutes self-directed exercise time per day.The self-directed exercise is to review and repeat the exercise actions during the supervised training session (4). 10 lessons in phase 4. This phase will focus on application in daily life. This will include rolling and balance training to enhance physical flexibility. This phase will take 6 days with 90 minutes supervised exercise and 1hours 30 minutes self-directed exercise time per day using. The self-directed exercise is to review and repeat the exercise actions during the supervised training session

Undertaking a supervised series of exercises on the Half-cut woods barefooted improves ankle flexion, and simultaneously strengthens the ankle and back of the calf muscles, quadriceps strength, knee and ankle range of motion, lower extremity muscle flexibility.
Half-cut Wood Training is designed for this study at Tonwo Clinic in China. Half-cut Wood Training materials consist of logs that are cut into halves and placed transversely across the floor (length=40cm-50cm, width=15cm-25cm, height=10cm-20cm).

An intervention guideline is designed for this study. The intervention will consist of 3 hours exercise session per day (which is equivalent 2 lessons per day) over 3 months period of time depending on individual's improvement level. The intervention is individual level based.
Intervention code [1] 312530 0
Rehabilitation
Comparator / control treatment
The control group consisted of people with symptoms of knee instability aged from 18 years and above. They are selected from the patients who are in the waiting list. They do usual activity and do not participate in any intervention program, but they will participate in the intervention when the intervention group participants have completed the program. The duration of the wait list will be 3 months.
Control group
Active

Outcomes
Primary outcome [1] 307588 0
Functional measures: Knee functioning will be assessed by a question (How well does knee work now?) from 0 (Cannot do any movement) to 10 (Can do any movement)

Timepoint [1] 307588 0
Patients receive 40 lessons over 2-3 months and exit the program based on the degree of improvement. They will be assessed at baseline and post intervention time after they have completed intervention after 2-3 months intervention time.
Primary outcome [2] 307589 0
Symptom Severity was assessed firstly by doctors, then patients themselves through self-report about their severity of knee instability from 1 (Not at all) to 5 (Extremely severe).
Timepoint [2] 307589 0
Baseline in time 1, then time 2 for post intervention assessment
Primary outcome [3] 307590 0
The clinician reported effect of Half-cut Wood Training will be assessed by the treating doctor about the improvement of patient knee instability from 0 to 100%.
Timepoint [3] 307590 0
Data will be collected at baseline and post intervention time.
Secondary outcome [1] 352375 0
Self-esteem Scale: The self-esteem scale 27 includes ten items on a 4 point Likert scale to assess self-esteem.

Timepoint [1] 352375 0
Data will be collected at baseline and post intervention time.
Secondary outcome [2] 353046 0
Self-efficacy: An adapted version of the Self-efficacy questionnaire, 28 consisting of 10 items using a five-point Likert Scale from 1 = Strongly disagree to 5 = Totally agree was used to measure self-efficacy. The overall reliability of the scale is acceptable (Cronbach's alpha= 0.83).

Timepoint [2] 353046 0
Data will be collected at baseline and post intervention time.
Secondary outcome [3] 353047 0
Quality of life scale: The SF-12 scale 29, consisting of 12 items, is used to assess quality of life on eight dimensions including physical functioning (PF),role-physical (RP),body pain (BP), general health (GH),vitality (VT),social functioning (SF),role-emotional (RE), and mental health,(MH). The summary score for physical health includes four dimensions of PF, RP, BP, and GH. The summary score for mental health includes four dimensions of VT, SF, RE, and MH. The raw scores were converted to the standard score. The range of the score is 0~100. The higher the score means the healthier and better perception of health. The scale has a reliability level of Chronbach Alpha of 0.78.
Timepoint [3] 353047 0
Data will be collected at baseline and post intervention time.
Secondary outcome [4] 353050 0
Telehealth assessment on anthropometry and biomedical factor: The HBF-306 is a body-fat analyzer device that uses bioelectrical impedance analysis (BIA) to assesses anthropometric and biomedical indexes of participants including BMI, waist circumference, fat percentage, protein percentage, bone mass, and muscle mass.26 Formulas were used to calculate these indexes, for example, Body fat percentage (%) ={body fat mass (kg) / body weight (kg)}×100, Body fat mass (kg) = Body weight (kg) – Fat-free mass (kg). The HBF-306 connected with an APP via WIFI connection, and measurement results are sent instantly to the APP when body composition factors will be measured.

Timepoint [4] 353050 0
Data will be collected as baseline, once per week from baseline to post intervention time, and post intervention time.

Eligibility
Key inclusion criteria
Patients with knee instability and with pains.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Healthy people and patients with arthritis are excluded from the study

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients are randomised to intervention and control group. Third party will participate in the concealment allocation process by generating sequence number and randomised participants into intervention and control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised program using SPSS is used to randomise people who consent to the study to either intervention or control group
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Repeated-measures analysis of variance (ANOVA) or intention to treat method will be employed to compare the two groups over time on these variables.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
24/10/2018
Date of last participant enrolment
Anticipated
10/03/2020
Actual
Date of last data collection
Anticipated
1/11/2019
Actual
Sample size
Target
50
Accrual to date
42
Final
Recruitment outside Australia
Country [1] 20876 0
China
State/province [1] 20876 0
Guang Zhou, Guang Dong Province

Funding & Sponsors
Funding source category [1] 300792 0
University
Name [1] 300792 0
Griffith University
Country [1] 300792 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Griffith University, School of Medicine
Parkland Drive, Gold Coast, Queensland, 4222
Australia
Country
Australia
Secondary sponsor category [1] 300344 0
None
Name [1] 300344 0
Address [1] 300344 0
Country [1] 300344 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301576 0
Griffith University Human Ethics Committee
Ethics committee address [1] 301576 0
Ethics committee country [1] 301576 0
Australia
Date submitted for ethics approval [1] 301576 0
01/12/2015
Approval date [1] 301576 0
30/11/2016
Ethics approval number [1] 301576 0
2015/522

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

Contacts
Principal investigator
Name 87442 0
A/Prof Jing Sun
Address 87442 0
School of Medicine, Griffith University, Australia
Parkland Drive, Gold Coast, Queensland Q4222
Country 87442 0
Australia
Phone 87442 0
+617 56780924
Fax 87442 0
+61756780303
Email 87442 0
j.sun@griffith.edu.au
Contact person for public queries
Name 87443 0
Jing Sun
Address 87443 0
School of Medicine, Griffith University, Australia
Parkland Drive, Gold Coast, Queensland, Q4222
Country 87443 0
Australia
Phone 87443 0
+617 56780924
Fax 87443 0
+6156780303
Email 87443 0
j.sun@griffith.edu.au
Contact person for scientific queries
Name 87444 0
Jing Sun
Address 87444 0
School of Medicine, Griffith University, Australia
Parkland Drive, Gold Coast, Queensland, Q4222
Country 87444 0
Australia
Phone 87444 0
+617 56780924
Fax 87444 0
+61756780303
Email 87444 0
j.sun@griffith.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Based on ethical reason. No individual person's information will be provided, but summary data will be provided.


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.