Total Knee ArthroplastyNCT00797875
PNF Stretching for TKA on ROM
A study testing PNF stretching and passive stretching in people with Total Knee Arthroplasty, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To investigate immediate and short term effects on angle of knee flexion, intensity of pain, strength of the knee extensor, and function of the lower extremity by using PNF stretching technique in patients with total knee arthroplasty. hypothesis:TKA patients may increase ROM after PNF stretching Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- PNF stretching and passive stretching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2008to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- OA knee
- primary unilateral TKA
Who cannot join
- knee flexion>110 or thigh girth > 55 cm
- poor cognition
- CNS or PNS neuromuscular disease
- received operation in recent 3 months
- joint infection and loosening
- revision total knee arthroplasty
- complication during follow up
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei, 100
Huei-Ming Chai, PHD, 02-33228140, hmchai@ntu.edu.tw
About this study
Official title: The Effects of PNF Stretching on Knee Motion Following TKA
To investigate immediate and short term effects on angle of knee flexion, intensity of pain, strength of the knee extensor, and function of the lower extremity by using PNF stretching technique in patients with total knee arthroplasty.
hypothesis:TKA patients may increase ROM after PNF stretching
Read the detailed description
Proprioceptive neuromuscular facilitation(PNF) is defined as a treatment method that promotes or hastens the response of the neuromuscular mechanism through stimulation of proprioceptors within the related muscles or joints. PNF stretching technique is a therapeutic technique using the PNF concept to the related muslces either to increase neuro-inhibition mechanism for releasing muscle spasm and elongating muscle length, or to increase neuro-excitation mechanism for enhancing muscle strength. Improvement in range of motion using PNF stretching technique has been reported superior to other techniques in previous literature, but those studies have only been done in healthy adults. Less is known in the effect of PNF stretching on improvement in joint restriction. Range of motion limitation usually disturbed the patients with total knee arthroplasty. PNF stretching techniques has been used frequently for patients with total knee arthroplasty in clinical practice to increase range of motion effectively and reduced knee pain during exercise. However there is no evidence-based research in such a technique for patients with total knee arthroplasty. This research project, therefore, will explore application of PNF stretch in changes of knee flexion, pain, muscle strength, and function of the lower extremity following total knee arthroplasty.
Purposes: To investigate immediate and short term effects on angle of knee flexion, intensity of pain, strength of the knee extensor, and function of the lower extremity by using PNF stretching technique in patients with total knee arthroplasty.
Method: Sixty patients who received total knee arthroplasty in National Taiwan University Hospital will be recruited in this study. They will be allocated randomly into either experimental or control groups. Conventional physical therapy will be given to all participants. Besides, the experimental group will assume PNF stretching technique from the third post-operative day to the day of discharge. This technique will be executed by the same physical therapist, including 5 trials of isometric knee extension for 6 s, followed by active knee flexion to the maximum range immediately, and holding for 10s. The rest interval will be 10 s. For the control group, passive stretch technique with the same treatment time will be given, instead. All participants will be asked to do home exercises after discharged from the hospital. The outcome measures will be given before and after the first session treatment on the same day, on the day of discharge, and one month after the operation. The variables measured will be (1) knee flexion angle measured with a universal goniometer, (2) maximum voluntary isometric strength of the knee extensor measured with a hand-held dynamometer, (3) pain score using pain visual analog scale, (4) function performance of the lower extremity measured with timed up and go test, (5) Knee Injury and Osteoarthritis Outcome Score (KOOS) to record 5 dimensions including the symptoms, stiffness, pain, difficulties in knee functions and/or daily activities, limitations in sports or recreational participation, and quality of life.
- Conditions
- Total Knee Arthroplasty
- Being tested
- PNF stretching, passive stretching
- Keywords
- proprioceptive neuromuscular facilitation stretching technique, total knee arthroplasty, range of motion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNF stretchingProcedure or surgery
PNF stretching x 5 repetitions and continue 3 days
passive stretchingProcedure or surgery
passive stretching x 5 repetitions continue 3 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | PNF stretching x 5 repetitions for 3 days Receives: Procedure: PNF stretching |
| 2 | Active comparator | passive stretching Receives: Procedure: passive stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
knee flexion angle
Measured: baseline and follow up
Secondary outcomes (4)
VAS pain score
Measured: baseline and follow up
knee extensor strength
Measured: baseline and follow up
time up and go test time
Measured: baseline and follow up
KOOS score
Measured: baseline and follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2008 (estimated)
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Huei-Ming Chai, PHD, Principal investigator, Nation Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797875
- Sponsor's protocol ID
- 200803064R
- Status last verified
- Nov 2008
- First submitted
- 24 Nov 2008
- Last updated
- 25 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of PNF Stretching on Knee Motion Following TKA
- ClinicalTrials.gov ID
- NCT00797875
- Acronym / sponsor ID
- 200803064R
- Conditions
- Total Knee Arthroplasty
- Keywords
- proprioceptive neuromuscular facilitation stretching technique, total knee arthroplasty, range of motion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 25 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate immediate and short term effects on angle of knee flexion, intensity of pain, strength of the knee extensor, and function of the lower extremity by using PNF stretching technique in patients with total knee arthroplasty.
hypothesis:TKA patients may increase ROM after PNF stretching
Detailed description
Proprioceptive neuromuscular facilitation(PNF) is defined as a treatment method that promotes or hastens the response of the neuromuscular mechanism through stimulation of proprioceptors within the related muscles or joints. PNF stretching technique is a therapeutic technique using the PNF concept to the related muslces either to increase neuro-inhibition mechanism for releasing muscle spasm and elongating muscle length, or to increase neuro-excitation mechanism for enhancing muscle strength. Improvement in range of motion using PNF stretching technique has been reported superior to other techniques in previous literature, but those studies have only been done in healthy adults. Less is known in the effect of PNF stretching on improvement in joint restriction. Range of motion limitation usually disturbed the patients with total knee arthroplasty. PNF stretching techniques has been used frequently for patients with total knee arthroplasty in clinical practice to increase range of motion effectively and reduced knee pain during exercise. However there is no evidence-based research in such a technique for patients with total knee arthroplasty. This research project, therefore, will explore application of PNF stretch in changes of knee flexion, pain, muscle strength, and function of the lower extremity following total knee arthroplasty.
Purposes: To investigate immediate and short term effects on angle of knee flexion, intensity of pain, strength of the knee extensor, and function of the lower extremity by using PNF stretching technique in patients with total knee arthroplasty.
Method: Sixty patients who received total knee arthroplasty in National Taiwan University Hospital will be recruited in this study. They will be allocated randomly into either experimental or control groups. Conventional physical therapy will be given to all participants. Besides, the experimental group will assume PNF stretching technique from the third post-operative day to the day of discharge. This technique will be executed by the same physical therapist, including 5 trials of isometric knee extension for 6 s, followed by active knee flexion to the maximum range immediately, and holding for 10s. The rest interval will be 10 s. For the control group, passive stretch technique with the same treatment time will be given, instead. All participants will be asked to do home exercises after discharged from the hospital. The outcome measures will be given before and after the first session treatment on the same day, on the day of discharge, and one month after the operation. The variables measured will be (1) knee flexion angle measured with a universal goniometer, (2) maximum voluntary isometric strength of the knee extensor measured with a hand-held dynamometer, (3) pain score using pain visual analog scale, (4) function performance of the lower extremity measured with timed up and go test, (5) Knee Injury and Osteoarthritis Outcome Score (KOOS) to record 5 dimensions including the symptoms, stiffness, pain, difficulties in knee functions and/or daily activities, limitations in sports or recreational participation, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: PNF stretchingPNF stretching x 5 repetitions for 3 days |
| 2 | Active comparator | Procedure: passive stretchingpassive stretching |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- OA knee
- primary unilateral TKA
Key exclusion criteria (7 listed)
- knee flexion>110 or thigh girth > 55 cm
- poor cognition
- CNS or PNS neuromuscular disease
- received operation in recent 3 months
- joint infection and loosening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PNF stretchingPNF stretching x 5 repetitions and continue 3 days | Procedure or surgery | 1 |
| passive stretchingpassive stretching x 5 repetitions continue 3 days | Procedure or surgery | 2 |
Primary outcome
knee flexion angle
Time frame: baseline and follow up
4 secondary outcomes
VAS pain score
Time frame: baseline and follow up
knee extensor strength
Time frame: baseline and follow up
time up and go test time
Time frame: baseline and follow up
KOOS score
Time frame: baseline and follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huei-Ming Chai, PHD principal investigator
Nation Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNF stretching and passive stretching in people with Total Knee Arthroplasty, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shiun-Jeng Lin (0939803219, seanjeng2000@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knee flexion angle (time frame: baseline and follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2008; AzTrials last refreshed its copy on 31 Oct 2026.