Knee OsteoarthritisNCT03734380
Lower Knee Joint Loading by Real-time Biofeedback Stair Walking Rehabilitation for Patients With MCKOA
A study testing Laboratory-based gait retraining (LGR) and Sensor-based gait retraining (SGR) in people with Knee Osteoarthritis, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
This study will establish a machine-learning algorithm to predict KAM using IMU sensors during stair ascent and descent; and then conduct a three-arm randomized controlled trial to compare the biomechanical and clinical difference between patients receiving a course of conventional laboratory-based stair retraining… Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Laboratory-based gait retraining (LGR) and Sensor-based gait retraining (SGR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 30 Dec 2023
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 45-80 years of age;
- patients with early medial compartment knee OA (Kellgren \& Lawrence grade = 1 or 2);
- self-reported knee pain at least once per week for the proceeding eight weeks;
- patients should be able to walk unaided for at least 60 minutes.
Who cannot join
- have a body mass index >35;
- have a known learning disability;
- use a shoe insert or knee brace;
- have received corticosteroid injection within the previous eight weeks;
- have absolute contraindications for vigorous physical activities according to the American College of Sports Medicine;
- in order to avoid floor effect of training, all subjects will undergo an initial screening and only those with KAM greater than 0.3 Nm/kg during level ground walking will be invited into the retraining study.
Trial locations and contacts
1 site in 1 country.
China1 site
The Hong Kong Polytechnic University
Hong Kong
Roy TH CHEUNG, PhD, Roy.Cheung@polyu.edu.hk
About this study
Official title: Lower Knee Joint Loading by Real-time Biofeedback Stair Walking Rehabilitation for Patients With Medial Compartment Knee Osteoarthritis
This study will establish a machine-learning algorithm to predict KAM using IMU sensors during stair ascent and descent; and then conduct a three-arm randomized controlled trial to compare the biomechanical and clinical difference between patients receiving a course of conventional laboratory-based stair retraining, sensor-based stair retraining, and walking exercise control (i.e., walking exercise without gait retraining). The investigators hypothesise that the wearable IMUs will accurately predict KAM during stair negotiation using machine-learning algorithm, with at least 80% measurement agreement with conventional calculation of KAM. The investigators also hypothesise that patients randomized to the laboratory-based and sensor-based stair retraining conditions would evidence similar (i.e., weak and non-significant differences) reduction in KAM (primary outcome) and an improvement of symptoms (secondary outcomes), but that these subjects would evidence larger reductions in KAM than subjects assigned to the walking exercise control condition.
Read the detailed description
Conventionally, gait retraining is necessarily implemented in a laboratory environment because evaluation of biomechanical markers, such as KAM, requires sophisticated motion capturing system and force plates. With advancement of wearable sensor technology, it is possible to measure gait biomechanics and provide real time biofeedback for gait retraining using inertial measurement unit (IMU), which is a lightweight and portable wireless device. In an ongoing government funded project, the investigators have developed IMU embedded footwear that measures KAM during level ground walking. The investigators have compared Least Absolute Shrinkage and Selection Operator (LASSO) regression and Random Forest in the prediction of KAM from IMU recordings. The investigators found that Random Forest could provide much higher KAM prediction accuracy than LASSO regression. The agreement between conventional laboratory-based and sensor-based measurement of KAM was approximately 90%. Based on investigators' previous research work, it is meaningful to extend the newly developed technology for KAM measurement during stair ascent and descent without the use of laboratory equipment. With the wearable sensors connected to the smartphones, gait retraining outside laboratory environment will become feasible but the effects of gait retraining using wearable sensors have not been directly verified.
Given these considerations, this project has two primary aims. The investigators will: (1) first establish a machine-learning algorithm to predict KAM using IMU sensors during stair ascent and descent; and then (2) conduct a three-arm randomized controlled trial to compare the biomechanical and clinical difference between patients receiving a course of conventional laboratory-based stair retraining, sensor-based stair retraining, and walking exercise control (i.e., walking exercise without gait retraining).
Primary hypothesis
Hypothesis 1: The wearable IMUs will accurately predict KAM during stair negotiation using machine-learning algorithm, with at least 80% measurement agreement with conventional calculation of KAM.
Hypothesis 2: Patients randomized to the laboratory-based and sensor-based stair retraining conditions would evidence similar (i.e., weak and non-significant differences) reduction in KAM (primary outcome) and an improvement of symptoms (secondary outcomes), but that these subjects would evidence larger reductions in KAM than subjects assigned to the walking exercise control condition.
- Conditions
- Knee Osteoarthritis
- Being tested
- Laboratory-based gait retraining (LGR), Sensor-based gait retraining (SGR), Walking exercise control (Ctrl)
- Keywords
- Gait retraining, Knee adduction moment, Wearable technology, Knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory-based gait retraining (LGR)Behavioural
Subjects in the LGR group will be encouraged to modify the gait pattern (e.g. adjusting foot progression angle, performing medial knee thrust, and/or lateral trunk lean) to lower their KAM to 80% of respective average baseline KAM obtained during normal unmodified gait. Real-time auditory feedback will be delivered using stereo speakers from both sides of the staircase. A middle C (261.6 Hz) tone and a high-pitched C (4186.0 Hz) of equal intensity will be generated at a footfall below and above the targeted 80% value, respectively. They will be advised to maintain their new gait pattern during their daily living after training.
Sensor-based gait retraining (SGR)Behavioural
Subjects in the SGR group will receive training similar to LGR, except the KAM measurement is based solely on inputs from IMUs embedded in the shoes. In addition, the auditory feedback will be delivered through a pair of earphones connected to a smartphone, which has been pre-installed with an app for KAM measurement. They will be advised to maintain their new gait pattern during their daily living after training.
Walking exercise control (Ctrl)Behavioural
Subjects in the Ctrl group will walk on the same instrumented staircase at a self-selected pace without any guidance on gait modification. The training period and training time per session will be identical to the other two groups. They will not be given any instructions for out-of-lab activities.
| Study group | Role | What they receive |
|---|---|---|
| Laboratory-based gait retraining (LGR) | Experimental | Subjects will attend 6 weekly sessions of stair ascent and descent exercise over six consecutive weeks. In each session, they walk at a self-selected speed on the instrumented staircase. The training time will be progressively increased from 15 to 30 minutes over the six sessions. The auditory feedback will be gradually removed in the last three sessions. Receives: Behavioral: Laboratory-based gait retraining (LGR) |
| Sensor-based gait retraining (SGR) | Experimental | Subjects will receive training similar to LGR, except the KAM measurement is based solely on inputs from IMUs embedded in the shoes. The training schedule, duration, and intensity will be identical to those of the LGR group. Receives: Behavioral: Sensor-based gait retraining (SGR) |
| Walking exercise control (Ctrl) | Experimental | Subjects will attend 6 weekly sessions of stair ascent and descent exercise over six consecutive weeks. In each session, they will walk on the same instrumented staircase at a self-selected pace without any guidance on gait modification. The training period and training time per session will be identical to the other two groups. Receives: Behavioral: Walking exercise control (Ctrl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knee adduction moment (KAM)
The surrogate marker of the medial compartment knee joint loading (i.e. KAM) will be measured by a 10-camera motion capture system (Vicon, Oxford Metrics Group, Oxford, UK) at 100 Hz and an instrumented staircase equipped with two force plates (Bertec, Columbus, OH, USA) at 1000Hz during stair ascent and descent at baseline assessment and after 6-week stair retraining.
Measured: baseline and 7 weeks
Secondary outcomes (2)
Change in Chinese Knee Injury and Osteoarthritis Outcome Score (KOOS)
The Chinese Knee Injury and Osteoarthritis Outcome Score (KOOS) will be used to assess knee pain, symptoms and physical function of the patients before and after stair retraining. This instrument contains 42 items addressing pain, symptoms, activities of daily living, sports and recreational function, and knee-related quality of life. The total score and sub-score for each domain (pain, symptoms, activities of daily living, sports/ recreational function, and knee-related quality of life) will be normalized from 0 to 100, with 100 indicating the worst possible state, 0 indicating no pain or loss of function.
Measured: baseline and 7 weeks
Chnage in validated visual analogue scale (VAS)
The validated visual analogue scale (VAS) of 100 mm will be used to assess overall knee pain level after each stair negotiation session, with 0 mm at the left-most end of the 100 mm scale indicating"No pain at all" and 100 mm at the right-most end indicating"Worst imaginable pain".
Measured: basleline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks and 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start1 Jan 2021 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- City University of Hong Kong, Chinese University of Hong Kong, Bern University of Applied Sciences
- Responsible party
- Principal investigator, Dr Roy Tsz-hei CHEUNG, The Hong Kong Polytechnic University
- Investigators
- Roy TH CHEUNG, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734380
- Sponsor's protocol ID
- HSEARS20181031005
- Status last verified
- Feb 2020
- First submitted
- 6 Nov 2018
- Last updated
- 11 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheung RTH, Ho KKW, Au IPH, An WW, Zhang JHW, Chan ZYS, Deluzio K, Rainbow MJ. Immediate and short-term effects of gait retraining on the knee joint moments and symptoms in patients with early tibiofemoral joint osteoarthritis: a randomized controlled trial. Osteoarthritis Cartilage. 2018 Nov;26(11):1479-1486. doi: 10.1016/j.joca.2018.07.011. Epub 2018 Aug 3.
PubMed 30081075Cheung RT, Ngai SP, Ho KK. Chinese adaptation and validation of the Knee Injury and Osteoarthritis Outcome Score (KOOS) in patients with knee osteoarthritis. Rheumatol Int. 2016 Oct;36(10):1449-54. doi: 10.1007/s00296-016-3539-7. Epub 2016 Jul 23.
PubMed 27449346Fong ICD, Li WSC, Tai WKJ, Tsang TWR, Zhang JH, Chen TLW, Baur H, Eichelberger P, Cheung RTH. Effect of foot progression angle adjustment on the knee adduction moment and knee joint contact force in runners with and without knee osteoarthritis. Gait Posture. 2018 Mar;61:34-39. doi: 10.1016/j.gaitpost.2017.12.029. Epub 2017 Dec 30.
PubMed 29304509Wei M, Chow TWS, Chan RHM. Heterogeneous feature subset selection using mutual information-based feature transformation. Neurocomputing. 2015;168:706-718. doi:10.1016/j.neucom.2015.05.053.
Yuqi Li, Jelfs B, Chan RHM. Entropy of surface EMG reflects object weight in grasp-and-lift task. Annu Int Conf IEEE Eng Med Biol Soc. 2017 Jul;2017:2530-2533. doi: 10.1109/EMBC.2017.8037372.
PubMed 29060414Zhang JH, Chan ZYS, Au IPH, An WW, Cheung RTH. Can the Newly Learnt Gait Pattern after Running Retraining be Translated to Untrained Conditions?: 1547 Board #8 May 31 1. Med Sci Sports Exerc. 2018;50:373. doi:10.1249/01.mss.0000536311.33285.d2.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Knee Joint Loading by Real-time Biofeedback Stair Walking Rehabilitation for Patients With Medial Compartment Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03734380
- Acronym / sponsor ID
- HSEARS20181031005
- Conditions
- Knee Osteoarthritis
- Keywords
- Gait retraining, Knee adduction moment, Wearable technology, Knee osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- City University of Hong Kong, Chinese University of Hong Kong, Bern University of Applied Sciences
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 8 Nov 2018 (actual)
- 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.
This study will establish a machine-learning algorithm to predict KAM using IMU sensors during stair ascent and descent; and then conduct a three-arm randomized controlled trial to compare the biomechanical and clinical difference between patients receiving a course of conventional laboratory-based stair retraining, sensor-based stair retraining, and walking exercise control (i.e., walking exercise without gait retraining). The investigators hypothesise that the wearable IMUs will accurately predict KAM during stair negotiation using machine-learning algorithm, with at least 80% measurement agreement with conventional calculation of KAM. The investigators also hypothesise that patients randomized to the laboratory-based and sensor-based stair retraining conditions would evidence similar (i.e., weak and non-significant differences) reduction in KAM (primary outcome) and an improvement of symptoms (secondary outcomes), but that these subjects would evidence larger reductions in KAM than subjects assigned to the walking exercise control condition.
Detailed description
Conventionally, gait retraining is necessarily implemented in a laboratory environment because evaluation of biomechanical markers, such as KAM, requires sophisticated motion capturing system and force plates. With advancement of wearable sensor technology, it is possible to measure gait biomechanics and provide real time biofeedback for gait retraining using inertial measurement unit (IMU), which is a lightweight and portable wireless device. In an ongoing government funded project, the investigators have developed IMU embedded footwear that measures KAM during level ground walking. The investigators have compared Least Absolute Shrinkage and Selection Operator (LASSO) regression and Random Forest in the prediction of KAM from IMU recordings. The investigators found that Random Forest could provide much higher KAM prediction accuracy than LASSO regression. The agreement between conventional laboratory-based and sensor-based measurement of KAM was approximately 90%. Based on investigators' previous research work, it is meaningful to extend the newly developed technology for KAM measurement during stair ascent and descent without the use of laboratory equipment. With the wearable sensors connected to the smartphones, gait retraining outside laboratory environment will become feasible but the effects of gait retraining using wearable sensors have not been directly verified.
Given these considerations, this project has two primary aims. The investigators will: (1) first establish a machine-learning algorithm to predict KAM using IMU sensors during stair ascent and descent; and then (2) conduct a three-arm randomized controlled trial to compare the biomechanical and clinical difference between patients receiving a course of conventional laboratory-based stair retraining, sensor-based stair retraining, and walking exercise control (i.e., walking exercise without gait retraining).
Primary hypothesis
Hypothesis 1: The wearable IMUs will accurately predict KAM during stair negotiation using machine-learning algorithm, with at least 80% measurement agreement with conventional calculation of KAM.
Hypothesis 2: Patients randomized to the laboratory-based and sensor-based stair retraining conditions would evidence similar (i.e., weak and non-significant differences) reduction in KAM (primary outcome) and an improvement of symptoms (secondary outcomes), but that these subjects would evidence larger reductions in KAM than subjects assigned to the walking exercise control condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laboratory-based gait retraining (LGR) | Experimental | Behavioral: Laboratory-based gait retraining (LGR)Subjects will attend 6 weekly sessions of stair ascent and descent exercise over six consecutive weeks. In each session, they walk at a self-selected speed on the instrumented staircase. The training time will be progressively increased from 15 to 30 minutes over the six sessions. The auditory feedback will be gradually removed in the last three sessions. |
| Sensor-based gait retraining (SGR) | Experimental | Behavioral: Sensor-based gait retraining (SGR)Subjects will receive training similar to LGR, except the KAM measurement is based solely on inputs from IMUs embedded in the shoes. The training schedule, duration, and intensity will be identical to those of the LGR group. |
| Walking exercise control (Ctrl) | Experimental | Behavioral: Walking exercise control (Ctrl)Subjects will attend 6 weekly sessions of stair ascent and descent exercise over six consecutive weeks. In each session, they will walk on the same instrumented staircase at a self-selected pace without any guidance on gait modification. The training period and training time per session will be identical to the other two groups. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 45-80 years of age;
- patients with early medial compartment knee OA (Kellgren \& Lawrence grade = 1 or 2);
- self-reported knee pain at least once per week for the proceeding eight weeks;
- patients should be able to walk unaided for at least 60 minutes.
Key exclusion criteria (6 listed)
- have a body mass index >35;
- have a known learning disability;
- use a shoe insert or knee brace;
- have received corticosteroid injection within the previous eight weeks;
- have absolute contraindications for vigorous physical activities according to the American College of Sports Medicine;
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 |
|---|---|---|
| Laboratory-based gait retraining (LGR)Subjects in the LGR group will be encouraged to modify the gait pattern (e.g. adjusting foot progression angle, performing medial knee thrust, and/or lateral trunk lean) to lower their KAM to 80% of respective average baseline KAM obtained during normal unmodified gait. Real-time auditory feedback will be delivered using stereo speakers from both sides of the staircase. A middle C (261.6 Hz) tone and a high-pitched C (4186.0 Hz) of equal intensity will be generated at a footfall below and above the targeted 80% value, respectively. They will be advised to maintain their new gait pattern during their daily living after training. | Behavioural | Laboratory-based gait retraining (LGR) |
| Sensor-based gait retraining (SGR)Subjects in the SGR group will receive training similar to LGR, except the KAM measurement is based solely on inputs from IMUs embedded in the shoes. In addition, the auditory feedback will be delivered through a pair of earphones connected to a smartphone, which has been pre-installed with an app for KAM measurement. They will be advised to maintain their new gait pattern during their daily living after training. | Behavioural | Sensor-based gait retraining (SGR) |
| Walking exercise control (Ctrl)Subjects in the Ctrl group will walk on the same instrumented staircase at a self-selected pace without any guidance on gait modification. The training period and training time per session will be identical to the other two groups. They will not be given any instructions for out-of-lab activities. | Behavioural | Walking exercise control (Ctrl) |
Primary outcome
Change in knee adduction moment (KAM)
Time frame: baseline and 7 weeks
The surrogate marker of the medial compartment knee joint loading (i.e. KAM) will be measured by a 10-camera motion capture system (Vicon, Oxford Metrics Group, Oxford, UK) at 100 Hz and an instrumented staircase equipped with two force plates (Bertec, Columbus, OH, USA) at 1000Hz during stair ascent and descent at baseline assessment and after 6-week stair retraining.
2 secondary outcomes
Change in Chinese Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: baseline and 7 weeks
Chnage in validated visual analogue scale (VAS)
Time frame: basleline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks and 7 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Background: PubMed 30081075Cheung RTH, Ho KKW, Au IPH, An WW, Zhang JHW, Chan ZYS, Deluzio K, Rainbow MJ. Immediate and short-term effects of gait retraining on the knee joint moments and symptoms in patients with early tibiofemoral joint osteoarthritis: a randomized controlled trial. Osteoarthritis Cartilage. 2018 Nov;26(11):1479-1486. doi: 10.1016/j.joca.2018.07.011. Epub 2018 Aug 3.
- Background: PubMed 27449346Cheung RT, Ngai SP, Ho KK. Chinese adaptation and validation of the Knee Injury and Osteoarthritis Outcome Score (KOOS) in patients with knee osteoarthritis. Rheumatol Int. 2016 Oct;36(10):1449-54. doi: 10.1007/s00296-016-3539-7. Epub 2016 Jul 23.
- Background: PubMed 29304509Fong ICD, Li WSC, Tai WKJ, Tsang TWR, Zhang JH, Chen TLW, Baur H, Eichelberger P, Cheung RTH. Effect of foot progression angle adjustment on the knee adduction moment and knee joint contact force in runners with and without knee osteoarthritis. Gait Posture. 2018 Mar;61:34-39. doi: 10.1016/j.gaitpost.2017.12.029. Epub 2017 Dec 30.
- BackgroundWei M, Chow TWS, Chan RHM. Heterogeneous feature subset selection using mutual information-based feature transformation. Neurocomputing. 2015;168:706-718. doi:10.1016/j.neucom.2015.05.053.
- Background: PubMed 29060414Yuqi Li, Jelfs B, Chan RHM. Entropy of surface EMG reflects object weight in grasp-and-lift task. Annu Int Conf IEEE Eng Med Biol Soc. 2017 Jul;2017:2530-2533. doi: 10.1109/EMBC.2017.8037372.
- BackgroundZhang JH, Chan ZYS, Au IPH, An WW, Cheung RTH. Can the Newly Learnt Gait Pattern after Running Retraining be Translated to Untrained Conditions?: 1547 Board #8 May 31 1. Med Sci Sports Exerc. 2018;50:373. doi:10.1249/01.mss.0000536311.33285.d2.
- Individual participant dataSharing planned: No
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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.
Roy TH CHEUNG, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laboratory-based gait retraining (LGR) and Sensor-based gait retraining (SGR) in people with Knee Osteoarthritis, run by The Hong Kong Polytechnic University at 1 site in China.
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 4 inclusion and 6 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 11 Feb 2020. 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 China. 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 Roy TH CHEUNG, PhD (2766 6739, Roy.Cheung@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in knee adduction moment (KAM) (time frame: baseline and 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03734380, which also lists 6 linked publications.
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 11 Feb 2020.