National Taipei University of Nursing and Health Sciences
Phase: NA
Conditions: Arthroplasty, Replacement, Knee Osteoarthritis
Sponsor: National Taipei University of Nursing and Health Sciences

 
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Questionnaire research Informed Consent 
Protocol Number 
 
IRB 
Number ECKIRB1100504 NCT 
Number 
NCT05030662 
Protocol Title 
The effect of “Walking stick exercise ” following total knee 
arthroplasty on lower limb strength, knee range of motion, and 
quality of life of patients 
Study Period 
2   year  0   month  
Sponsor/Pharmaceutical 
Company for this study 
No 
Study Institution 
En Chu Kong hospital 
Principal Investigator 
CHOU 
Yu- Hua 
Institution 
En Chu Kong hospital 
Department/Title 
Nursing Department 
/ 
Chief 
Nursing 
of 
orthopedic ward 
Telephone 
No. 
/ 
extension 
02-26723456/6259 
Cellphone number 
0927977137 
Sub-Investigator 
Chan 
Pi-Tuan 
Institution 
En Chu Kong hospital 
Department/Title 
Nursing Department 
/ Director 
Telephone 
No. 
/ 
extension 
02-26723456/6600 
Cellphone number 
0958658098 
Study nurse 
HUANG 
Yu-Ning 
Institution 
En Chu Kong hospital 
Department/Title 
Nursing Department 
/ Nurse of orthopedic 
ward 
Telephone 
No. 
/ 
extension 
02-26723456/6259 
Cellphone number 
0928795970 
Contact person 
CHOU 
Yu- Hua 
Institution 
En Chu Kong hospital 
Department/Title 
Nursing Department 
/ 
Chief 
Nursing 
of 
orthopedic ward 

 
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Telephone 
No. 
/ 
extension 
02-26723456/6259 
Cellphone number 
0927977137 
1 
Background 
The prevalence of knee osteoarthritis (OA) is 15~20% in people 60 years old or 
older in Taiwan, according to 2019 Taiwan health and welfare report. According to the 
data from Taiwan's Health Insurance Bureau, about 20,000 people undergo total knee 
replacement (TKR) every year between 2009 and 2011. Previous studies found that 
rehabilitation program following TKR could reduce postoperative pain and increased 
muscle power and the range of motion of the knee extension. “Walking stick exercises” 
can improve walking ability and knee range of motion. 
2 
Purpose of this study 
The purpose of this study is to examine whether “walking stick exercises” can 
improve lower limb strength, knee range of motion, and quality of life compared with 
conventional care 12 weeks after total knee arthroplasty. 
3 
Materials and Methods 
The study will be undertaken in the Department Orthopaedics of a regional 
teaching hospital. All patients who meet the inclusion criteria are admitted for primary 
total knee arthroplasty and the informed consent were obtained. 
3.1 
Inclusion criteria 
(1) Patients with symptomatic knee osteoarthritis 
(2) Receipt of elective unilateral primary knee arthroplasty surgery 
(3) Age between 60 and 85 years 
(4) Informed consent 
3.2 
Exclusion criteria 
(1) Non-degenerative arthritis, including rhematoid arthritis, or traumativ arthritis 
(2) Patients receiving rehabilitation simultaneously 
(3) Patients with other musculoskeletal or neurological problem, including fractures, 
Parkinsonism, cerebrovascular events, or patients with multiple comorbidity 

 
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(4) Cancer  patients receive chemotherapy 
(5) Patients with peri-operative complication that has adverse effect on outcomes, for 
example: intra-operative fractures, thromboembolism, peri-operative infections, or 
phlebitis. 
4 
Methods and related procedures of this study 
The appropriate sample size is calculated by G-power (effect size, f = 0.25, alpha 
error = 0.05, power = 0.80, number of groups = 3). If the rate of lost to follow up is 7%, a 
minimum sample size of 44 for each group is necessary. 
This is a longitudinal-experimental study. The data collection and analysis are in a 
single-blind manner. The study will be undertaken in the Department Orthopaedics of a 
regional teaching hospital. All patients who meet the inclusion criteria are admitted for 
primary total knee arthroplasty and assigned to control group or intervention group 
randomly. The 44 patients in the control group received routine guidance of " 
Rehabilitation and precautions for artificial knee replacement ". In addition to the routine 
guidance, the 44 patients in the intervention group received two educations of " Walking 
stick exercise " on the day before surgery and before discharge, as well as a follow-up 
call at least once a week after discharge. The outcome measurements include 30-second 
chair stand test, knee range of motion (ROM), and Knee injury and Osteoarthritis 
Outcome Score (KOOS). The 30-second chair stand test, knee ROM were recorded at 
baseline (preoperative period after patient admission), 1 weeks and 6 weeks and 12 
weeks after operation. The 30-second chair stand test, knee ROM were recorded and 
KOOS was scored. Descriptive statistics, chi-square test, independent sample t-test, 
paired-sample t -test, and generalized estimating equation (GEE) were used for statistical 
data analysis. Statistical methods use descriptive statistics, chi-square test, independent 
sample t -test, paired-sample t -test, and GEE for data analysis. 
 
5 
Possible risks and and countermeasures 
The questionnaire itself might be disturbing to the patients during their hospital stay. 
6 
Anticipated study benefits 
Participating in this trial does not guarantee improvement of your disease or bring 
you any other direct benefits. However, the trial research results may be helpful to the 

 
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Sponsor and/or Principal Investigator and may also benefit other patients with the same 
disease in the future. 
7 
Contraindications, restrictions and rules that must be abided by during the trial 
1.Complete the questionnaire. 2.Perform the rehabilitation program according to the 
protocol. 
8 
Confidentiality of subject's personal information 
En Chu Kong Hospital will abide by the law to keep the confidentiality of any 
record containing your identification and your personal private information, and will not 
disclose it. The research staff will assign you with a research code, and this code will not 
show any identifiable information such as your name, identification number or address. 
In the event that trial results are published, your identification will continue to be kept 
confidential. You also understand that by signing this consent form, you are approving 
direct use of your original medical records by the monitors, auditors, (the name of the 
hospital IRB) and the competent authorities, in order to ensure that the clinical trial is 
conducted and data are collected in accordance with applicable laws and regulations. The 
aforementioned personnel guarantee the confidentiality of your identity will not be 
violated. Except the aforementioned authority’s inspection as required by law, we will 
carefully protect your privacy. 
9 
Compensation and insurance 
    The hospital will provide professional medical care and consultations for adverse 
events or damages resulting from following the protocol designed for this clinical trial. 
You will not be responsible for the necessary medical expenses with respect to the 
treatment for the adverse events or damages. 
Reimbursement for participating in the trial research is NT$150 Convenience Store 
Gift Voucher. 
10 Rights and interests of the subject 
10.1 During the trial, if you have any questions about the nature of the trial or any 
concerns about your rights as a patient, please contact the 周玉華to request for 
consultation. The telephone number is 0927-977-137. 
10.2 During the trial, if you have any questions about the nature of the trial or any 

 
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concerns about your rights as a patient, or suspect that you have suffered injury as a 
result of participating in this research, please contact the ECK IRB to request for 
consultation. The telephone number is 02-26723456 ext. 6835. E-mail: 
eckirb@km.eck.org.tw 
10.3 This trial was approved by the ECK IRB. In accordance with FDA regulations, an 
IRB has the authority to approve, require modifications in (to secure approval), or 
disapprove research. This group review serves an important role in the protection of 
the rights and welfare of human research subjects. 
10.4 The purpose of IRB review is to assure, both in advance and by periodic review, 
that appropriate steps are taken to protect the rights and welfare of humans 
participating as subjects in the research. To accomplish this purpose, IRBs use a 
group process to review research protocols and related materials (e.g., informed 
consent documents and investigator brochures) to ensure protection of the rights and 
welfare of human subjects of research. 
10.5 All clinical trials have risks. Please make your decision after careful consideration. 
11 Withdrawal and termination of the trial 
11.1 You are free to decide whether to take part in this trial. During the trial, you can 
withdraw your consent and leave the trial at any time, without giving any reason, 
and no unpleasantness will be caused, nor will your medical care from your 
physician be affected. 
12 Signature 
12.1 The Principal Investigator/Sub-investigator or his/her authorized personnel has 
explained in detail the nature and objectives of the above research method in this 
protocol, as well as the possible risks and benefits. 
Signature of Principal Investigator/Sub-investigator:                
Date:       (Month)          (Day),           (Year) 
12.2 I fully understand the research method mentioned above and the possible risks and 
benefits after the explanation, and my questions about the clinical trial have been 
answered in full detail. I agree to participate in this research voluntarily and will 

 
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hold a duplicate of the Informed Consent Form. 
Signature of the Subject:                
Date:       (Month)          (Day),           (Year) 
This consent form is in duplicate, with each party holding one copy after 
being signed.