Total Knee ReplacementNCT05958212
Innovative Gait Training for People With Knee Osteoarthritis Using Dual Belt Treadmill
A study testing Gait training program and Conventional training only in people with Total Knee Replacement, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Knee osteoarthritis (OA) is the most common form of arthritis and is the leading cause of chronic musculoskeletal pain and functional disability. Gait assessment is essential for the rehabilitation of people with knee OA. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- Gait training program and Conventional training only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2022to 1 Jun 2025
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Potential participants will be recruited from BH and QEH, where patients with confirmed diagnosis of K\&L grade 2 to 4 knee OA who have received TKR will be eligible for this study.
Who cannot join
- Subjects with prior history of knee surgery, impaired lower limb function other than knee joint or has previously received an intra-articular injection to knee will be excluded from the study to ensure validity of results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Unilateral Speed-upscaling Gait Training in Promoting Pain and Functional Recovery in People With Total Knee Replacement: A Randomised Controlled Trial
Knee osteoarthritis (OA) is the most common form of arthritis and is the leading cause of chronic musculoskeletal pain and functional disability. Gait assessment is essential for the rehabilitation of people with knee OA. It may reflect the impact of knee OA on functional outcomes and allow prediction of prognosis for patients. Various people with knee OA may demonstrate different forms of gait asymmetry owing to his/her own knee pain experienced and joint instability perceived. The stance time, peak vertical and peak propulsive ground reaction force have found to be significantly reduced on the OA affected limb. People with knee OA demonstrate compensatory gait pattern to minimize joint loading. It is quite common that the severity of the OA symptoms varies in the two knees, and patients may demonstrate various forms of gait asymmetries, such changes in gait biomechanics does not only impact the affected knee joint. Its impact extends proximally along the kinetic chain system of the human body, where often knee OA patients presents with significantly increased lateral trunk flexion towards ipsilateral limb during walking.
Gait asymmetry as a result of knee OA has been constantly reported in both human and animal studies. Previous studies showed that people with unilateral knee symptoms may adapt to asymmetrical movement patterns, which results in reduced net knee extension demand moments Research interest on gait asymmetry has been expanded to other cohort of patients, e.g. hemiplegic stroke patients. Extensive evidence has shown that the modification of walking speed has a positive impact on the propulsive force of hemiplegic patient's affected limb. These encouraging results have form indications for future investigation on evaluating the impact of innovative gait training in promoting symmetrical gait pattern, targeting patients with unilateral knee OA or bilateral knee OA of different severity. The objective to assess knee OA's gait under different walking conditions is now feasible with the access to the dualbelt treadmill at PolyU. In addition to walking speed modification, emerging backward walking as part of gait training rehabilitation in knee OA patients has become increasingly popular. Backward walking is regulated by the same central pattern generator as forward walking; however, it does not require initial heel contact in early stance phase of the gait cycle as it would be in forward walking. This leads to reduced compression force at the patella-femoral joint and decreased force absorption imposed at the knee joint. Recent systematic review and meta-analysis have suggested combining backward walking to conventional physiotherapy has significantly improve clinical outcomes, including pain control, functional disability, muscle strength, gait pattern, balance and postural stability in knee OA patients.
All of above-mentioned findings have highlighted the connection between specific gait parameters and clinical outcomes, and also the importance of monitoring these changes as disease naturally progress. It is also vital to note the benefits of emerging technologies as the implementation of novel strategies can optimize the ambulatory capacity of the individual, which therefore enhance their recovery potential and quality of life.
Read the detailed description
This study is a two-armed, parallel group, single centered randomized controlled trial investigating the efficacy of gait training combined with conventional treatment as compared to conventional treatment alone in post-TKR rehabilitation program. Potential participants will be recruited from BH and QEH, where patients with confirmed diagnosis of K\&L grade 2 to 4 knee OA who have received TKR will be eligible for this study. Subjects with prior history of knee surgery, impaired lower limb function other than knee joint or has previously received an intra-articular injection to knee will be excluded from the study to ensure validity of results. It aims to compare and evaluate the effectiveness of combined conventional rehabilitation with gait training on dual-belt treadmill and conventional rehabilitation alone on post-operative clinical outcomes and gait pattern.
- Conditions
- Total Knee Replacement
- Being tested
- Gait training program, Conventional training only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait training programBehavioural
Gait training program at PolyU is a supervised rehabilitation program performed on the dual-belt treadmill. It consists of forward walking at increased speed over the affected leg and retro walking (backward walking) at individual's own pace (5 minutes/set for three sets, with rest periods in each session). This program also consists of a standardized set of warm-up and cool-down exercises at each training session.
Participants will also receive conventional physiotherapy treatment in the outpatient physiotherapy clinic.
Conventional training onlyBehavioural
Conventional physiotherapy treatment in the outpatient physiotherapy clinic.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in the intervention group will receive a weekly gait training program at PolyU in addition to conventional treatment at Outpatient Patient Department (OPD) of The Hong Kong Buddhist Hospital twice per week for 4 consecutive weeks. Gait training program at PolyU is a supervised rehabilitation program performed on the dual-belt treadmill. Receives: Behavioral: Gait training program |
| Control Group | Active comparator | Participants in control group will only receive conventional treatment at Outpatient Patient Department (OPD) of BH twice per week for 4 consecutive weeks. Receives: Behavioral: Conventional training only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Arthritis Index
Pain intensity, stiffness and function of the operated knee will be assessed using the Western Ontario and McMaster Universities Arthritis Index.
Minimum：0 Maximum：96 Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: pre-operative session (T1)
Western Ontario and McMaster Universities Arthritis Index
Pain intensity, stiffness and function of the operated knee will be assessed using the Western Ontario and McMaster Universities Arthritis Index.
Minimum：0 Maximum：96 Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: two-weeks post-operation (T2)
Western Ontario and McMaster Universities Arthritis Index
Pain intensity, stiffness and function of the operated knee will be assessed using the Western Ontario and McMaster Universities Arthritis Index.
Minimum：0 Maximum：96 Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: six-weeks post-operation(T3)
Western Ontario and McMaster Universities Arthritis Index
Pain intensity, stiffness and function of the operated knee will be assessed using the Western Ontario and McMaster Universities Arthritis Index.
Minimum：0 Maximum：96 Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: six-month follow-up
Secondary outcomes (36)
30s Chair-Stand Test
This test is chosen as recommended by the Osteoarthritis Research Society International Advisory Group (OARSI) for their sensitivity in detecting change in knee functions over time in knee OA patients. Testing and scoring procedures strictly adheres to the standardization and instructions suggested in the OARSI recommendation.
Measured: pre-operative session (T1)
30s Chair-Stand Test
This test is chosen as recommended by the Osteoarthritis Research Society International Advisory Group (OARSI) for their sensitivity in detecting change in knee functions over time in knee OA patients. Testing and scoring procedures strictly adheres to the standardization and instructions suggested in the OARSI recommendation.
Measured: two-weeks post-operation (T2)
30s Chair-Stand Test
This test is chosen as recommended by the Osteoarthritis Research Society International Advisory Group (OARSI) for their sensitivity in detecting change in knee functions over time in knee OA patients. Testing and scoring procedures strictly adheres to the standardization and instructions suggested in the OARSI recommendation.
Measured: six-weeks post-operation(T3)
30s Chair-Stand Test
This test is chosen as recommended by the Osteoarthritis Research Society International Advisory Group (OARSI) for their sensitivity in detecting change in knee functions over time in knee OA patients. Testing and scoring procedures strictly adheres to the standardization and instructions suggested in the OARSI recommendation.
Measured: six-month follow-up
40-m Fast-Paced Walk Test
This test is chosen as recommended by the Osteoarthritis Research Society International Advisory Group (OARSI) for their sensitivity in detecting change in knee functions over time in knee OA patients. Testing and scoring procedures strictly adheres to the standardization and instructions suggested in the OARSI recommendation.
Measured: pre-operative session (T1)
40-m Fast-Paced Walk Test
This test is chosen as recommended by the Osteoarthritis Research Society International Advisory Group (OARSI) for their sensitivity in detecting change in knee functions over time in knee OA patients. Testing and scoring procedures strictly adheres to the standardization and instructions suggested in the OARSI recommendation.
Measured: two-weeks post-operation (T2)
40-m Fast-Paced Walk Test
This test is chosen as recommended by the Osteoarthritis Research Society International Advisory Group (OARSI) for their sensitivity in detecting change in knee functions over time in knee OA patients. Testing and scoring procedures strictly adheres to the standardization and instructions suggested in the OARSI recommendation.
Measured: six-weeks post-operation(T3)
40-m Fast-Paced Walk Test
This test is chosen as recommended by the Osteoarthritis Research Society International Advisory Group (OARSI) for their sensitivity in detecting change in knee functions over time in knee OA patients. Testing and scoring procedures strictly adheres to the standardization and instructions suggested in the OARSI recommendation.
Measured: six-month follow-up
Stair-Climb Test
This test is chosen as recommended by the Osteoarthritis Research Society International Advisory Group (OARSI) for their sensitivity in detecting change in knee functions over time in knee OA patients. Testing and scoring procedures strictly adheres to the standardization and instructions suggested in the OARSI recommendation.
Measured: pre-operative session (T1)
Stair-Climb Test
This test is chosen as recommended by the Osteoarthritis Research Society International Advisory Group (OARSI) for their sensitivity in detecting change in knee functions over time in knee OA patients. Testing and scoring procedures strictly adheres to the standardization and instructions suggested in the OARSI recommendation.
Measured: two-weeks post-operation (T2)
Stair-Climb Test
This test is chosen as recommended by the Osteoarthritis Research Society International Advisory Group (OARSI) for their sensitivity in detecting change in knee functions over time in knee OA patients. Testing and scoring procedures strictly adheres to the standardization and instructions suggested in the OARSI recommendation.
Measured: six-weeks post-operation(T3)
Stair-Climb Test
This test is chosen as recommended by the Osteoarthritis Research Society International Advisory Group (OARSI) for their sensitivity in detecting change in knee functions over time in knee OA patients. Testing and scoring procedures strictly adheres to the standardization and instructions suggested in the OARSI recommendation.
Measured: six-month follow-up
Timed Up-and-Go Test
This test is chosen as recommended by the Osteoarthritis Research Society International Advisory Group (OARSI) for their sensitivity in detecting change in knee functions over time in knee OA patients. Testing and scoring procedures strictly adheres to the standardization and instructions suggested in the OARSI recommendation.
Measured: pre-operative session (T1)
Timed Up-and-Go Test
This test is chosen as recommended by the Osteoarthritis Research Society International Advisory Group (OARSI) for their sensitivity in detecting change in knee functions over time in knee OA patients. Testing and scoring procedures strictly adheres to the standardization and instructions suggested in the OARSI recommendation.
Measured: two-weeks post-operation (T2)
Timed Up-and-Go Test
This test is chosen as recommended by the Osteoarthritis Research Society International Advisory Group (OARSI) for their sensitivity in detecting change in knee functions over time in knee OA patients. Testing and scoring procedures strictly adheres to the standardization and instructions suggested in the OARSI recommendation.
Measured: six-weeks post-operation(T3)
Timed Up-and-Go Test
This test is chosen as recommended by the Osteoarthritis Research Society International Advisory Group (OARSI) for their sensitivity in detecting change in knee functions over time in knee OA patients. Testing and scoring procedures strictly adheres to the standardization and instructions suggested in the OARSI recommendation.
Measured: six-month follow-up
6-min Walk Test
This test is chosen as recommended by the Osteoarthritis Research Society International Advisory Group (OARSI) for their sensitivity in detecting change in knee functions over time in knee OA patients. Testing and scoring procedures strictly adheres to the standardization and instructions suggested in the OARSI recommendation.
Measured: pre-operative session (T1)
6-min Walk Test
This test is chosen as recommended by the Osteoarthritis Research Society International Advisory Group (OARSI) for their sensitivity in detecting change in knee functions over time in knee OA patients. Testing and scoring procedures strictly adheres to the standardization and instructions suggested in the OARSI recommendation.
Measured: two-weeks post-operation (T2)
6-min Walk Test
This test is chosen as recommended by the Osteoarthritis Research Society International Advisory Group (OARSI) for their sensitivity in detecting change in knee functions over time in knee OA patients. Testing and scoring procedures strictly adheres to the standardization and instructions suggested in the OARSI recommendation.
Measured: six-weeks post-operation(T3)
6-min Walk Test
This test is chosen as recommended by the Osteoarthritis Research Society International Advisory Group (OARSI) for their sensitivity in detecting change in knee functions over time in knee OA patients. Testing and scoring procedures strictly adheres to the standardization and instructions suggested in the OARSI recommendation.
Measured: six-month follow-up
Step Length Asymmetry
Step length is the anterior-posterior (i.e. along the x-axis) distance in millimeters between ankles markers at heel strike. Equal step lengths result in zero step length asymmetry. Step length asymmetry is related to propulsive force generation during paretic walking. In situation where the unaffected leg's step length is longer than the affected leg's step length indicates step length asymmetry. Step length asymmetry is then quantified by using a step length ratio, defined as step length of the (more) affected limb divided by the step length non-affected limb (or less affected limb). This results in a unitless parameter that is essential for comparing inter-subject differences.The participants will walk in 3 conditions. i: comfortable speed; ii: affected limb accelerated (by 30%) and iii affected limb decelerated (by 30%).
Measured: pre-operative session (T1)
Step Length Asymmetry
Step length is the anterior-posterior (i.e. along the x-axis) distance in millimeters between ankles markers at heel strike. Equal step lengths result in zero step length asymmetry. Step length asymmetry is related to propulsive force generation during paretic walking. In situation where the unaffected leg's step length is longer than the affected leg's step length indicates step length asymmetry. Step length asymmetry is then quantified by using a step length ratio, defined as step length of the (more) affected limb divided by the step length non-affected limb (or less affected limb). This results in a unitless parameter that is essential for comparing inter-subject differences. The participants will walk in 3 conditions. i: comfortable speed; ii: affected limb accelerated (by 30%) and iii affected limb decelerated (by 30%).
Measured: two-weeks post-operation (T2)
Step Length Asymmetry
Step length is the anterior-posterior (i.e. along the x-axis) distance in millimeters between ankles markers at heel strike. Equal step lengths result in zero step length asymmetry. Step length asymmetry is related to propulsive force generation during paretic walking. In situation where the unaffected leg's step length is longer than the affected leg's step length indicates step length asymmetry. Step length asymmetry is then quantified by using a step length ratio, defined as step length of the (more) affected limb divided by the step length non-affected limb (or less affected limb). This results in a unitless parameter that is essential for comparing inter-subject differences. The participants will walk in 3 conditions. i: comfortable speed; ii: affected limb accelerated (by 30%) and iii affected limb decelerated (by 30%).
Measured: six-weeks post-operation(T3)
Step Length Asymmetry
Step length is the anterior-posterior (i.e. along the x-axis) distance in millimeters between ankles markers at heel strike. Equal step lengths result in zero step length asymmetry. Step length asymmetry is related to propulsive force generation during paretic walking. In situation where the unaffected leg's step length is longer than the affected leg's step length indicates step length asymmetry. Step length asymmetry is then quantified by using a step length ratio, defined as step length of the (more) affected limb divided by the step length non-affected limb (or less affected limb). This results in a unitless parameter that is essential for comparing inter-subject differences. The participants will walk in 3 conditions. i: comfortable speed; ii: affected limb accelerated (by 30%) and iii affected limb decelerated (by 30%).
Measured: six-month follow-up
Knee Moment
Knee Moment is a measurement of the medial tibiofemoral contact force. The initial peak knee adduction torque during walking is a strong predictor of the severity and rate of progression of medial compartment knee OA. The KAM is generated by the combination of ground reaction force, which passes medially to the knee joint during walking. It is recorded by two force plates at 1080Hz and 3D kinematic data acquired by the infrared camera system at 120Hz using the VICON Motion System, Oxford, UK. In this particular study, subjects that has been selected to receive 3D bipedal locomotion analysis using the Vicon Optical Motion Capturing system will be assessed under various walking conditions; The participants will walk in 3 conditions. i: comfortable speed; ii: affected limb accelerated (by 30%) and iii affected limb decelerated (by 30%).
Measured: pre-operative session (T1)
Knee Moment
Knee Moment is a measurement of the medial tibiofemoral contact force. The initial peak knee adduction torque during walking is a strong predictor of the severity and rate of progression of medial compartment knee OA. The KAM is generated by the combination of ground reaction force, which passes medially to the knee joint during walking. It is recorded by two force plates at 1080Hz and 3D kinematic data acquired by the infrared camera system at 120Hz using the VICON Motion System, Oxford, UK. In this particular study, subjects that has been selected to receive 3D bipedal locomotion analysis using the Vicon Optical Motion Capturing system will be assessed under various walking conditions; The participants will walk in 3 conditions. i: comfortable speed; ii: affected limb accelerated (by 30%) and iii affected limb decelerated (by 30%).
Measured: two-weeks post-operation (T2)
Knee Moment
Knee Moment is a measurement of the medial tibiofemoral contact force. The initial peak knee adduction torque during walking is a strong predictor of the severity and rate of progression of medial compartment knee OA. The KAM is generated by the combination of ground reaction force, which passes medially to the knee joint during walking. It is recorded by two force plates at 1080Hz and 3D kinematic data acquired by the infrared camera system at 120Hz using the VICON Motion System, Oxford, UK. In this particular study, subjects that has been selected to receive 3D bipedal locomotion analysis using the Vicon Optical Motion Capturing system will be assessed under various walking conditions; The participants will walk in 3 conditions. i: comfortable speed; ii: affected limb accelerated (by 30%) and iii affected limb decelerated (by 30%).
Measured: six-weeks post-operation(T3)
Knee Moment
Knee Moment is a measurement of the medial tibiofemoral contact force. The initial peak knee adduction torque during walking is a strong predictor of the severity and rate of progression of medial compartment knee OA. The KAM is generated by the combination of ground reaction force, which passes medially to the knee joint during walking. It is recorded by two force plates at 1080Hz and 3D kinematic data acquired by the infrared camera system at 120Hz using the VICON Motion System, Oxford, UK. In this particular study, subjects that has been selected to receive 3D bipedal locomotion analysis using the Vicon Optical Motion Capturing system will be assessed under various walking conditions; The participants will walk in 3 conditions. i: comfortable speed; ii: affected limb accelerated (by 30%) and iii affected limb decelerated (by 30%).
Measured: six-month follow-up
Ground Reaction Force
Ground Reaction Force ( GRF) is a gait variable that has been reported to be closely associated with walking speed, severity of disease and presence of step length asymmetry in knee OA patients. GRF is determined using a frequency threshold of 20Hz, and the resultant force (measured in Newtons) will be normalized using division normalization. It is a common practice for studies evaluating GRF to normalize these forces by linear scaling them to subject's body weight, in order to allow comparison between subjects.The participants will walk in 3 conditions. i: comfortable speed; ii: affected limb accelerated (by 30%) and iii affected limb decelerated (by 30%).
Measured: pre-operative session (T1)
Ground Reaction Force
Ground Reaction Force ( GRF) is a gait variable that has been reported to be closely associated with walking speed, severity of disease and presence of step length asymmetry in knee OA patients. GRF is determined using a frequency threshold of 20Hz, and the resultant force (measured in Newtons) will be normalized using division normalization. It is a common practice for studies evaluating GRF to normalize these forces by linear scaling them to subject's body weight, in order to allow comparison between subjects.The participants will walk in 3 conditions. i: comfortable speed; ii: affected limb accelerated (by 30%) and iii affected limb decelerated (by 30%).
Measured: two-weeks post-operation (T2)
Ground Reaction Force
Ground Reaction Force ( GRF) is a gait variable that has been reported to be closely associated with walking speed, severity of disease and presence of step length asymmetry in knee OA patients. GRF is determined using a frequency threshold of 20Hz, and the resultant force (measured in Newtons) will be normalized using division normalization. It is a common practice for studies evaluating GRF to normalize these forces by linear scaling them to subject's body weight, in order to allow comparison between subjects.The participants will walk in 3 conditions. i: comfortable speed; ii: affected limb accelerated (by 30%) and iii affected limb decelerated (by 30%).
Measured: six-weeks post-operation(T3)
Ground Reaction Force
Ground Reaction Force ( GRF) is a gait variable that has been reported to be closely associated with walking speed, severity of disease and presence of step length asymmetry in knee OA patients. GRF is determined using a frequency threshold of 20Hz, and the resultant force (measured in Newtons) will be normalized using division normalization. It is a common practice for studies evaluating GRF to normalize these forces by linear scaling them to subject's body weight, in order to allow comparison between subjects.The participants will walk in 3 conditions. i: comfortable speed; ii: affected limb accelerated (by 30%) and iii affected limb decelerated (by 30%).
Measured: six-month follow-up
Osteoarthritis Fears and Beliefs Questionnaire (KOBeQ)
Fear avoidance belief will be assessed using self-reported questionnaires, The Knee Osteoarthritis Fears and Beliefs Questionnaire (KOBeQ) Minimum：0 Maximum：99 Higher scores on the KOFBeQ indicate better health status.
Measured: pre-operative session (T1)
Osteoarthritis Fears and Beliefs Questionnaire (KOBeQ)
Fear avoidance belief will be assessed using self-reported questionnaires, The Knee Osteoarthritis Fears and Beliefs Questionnaire (KOBeQ) Minimum：0 Maximum：99 Higher scores on the KOFBeQ indicate better health status.
Measured: two-weeks post-operation (T2)
Osteoarthritis Fears and Beliefs Questionnaire (KOBeQ)
Fear avoidance belief will be assessed using self-reported questionnaires, The Knee Osteoarthritis Fears and Beliefs Questionnaire (KOBeQ) Minimum：0 Maximum：99 Higher scores on the KOFBeQ indicate better health status.
Measured: six-weeks post-operation(T3)
Osteoarthritis Fears and Beliefs Questionnaire (KOBeQ)
Fear avoidance belief will be assessed using self-reported questionnaires, The Knee Osteoarthritis Fears and Beliefs Questionnaire (KOBeQ) Minimum：0 Maximum：99 Higher scores on the KOFBeQ indicate better health status.
Measured: six-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start1 Jun 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Buddhist Hospital, The Queen Elizabeth Hospital
- Responsible party
- Principal investigator, Dr Patrick Kwong, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958212
- Sponsor's protocol ID
- 2021-0212
- Status last verified
- Jul 2023
- First submitted
- 19 Jun 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Unilateral Speed-upscaling Gait Training in Promoting Pain and Functional Recovery in People With Total Knee Replacement: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05958212
- Acronym / sponsor ID
- 2021-0212
- Conditions
- Total Knee Replacement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- The Hong Kong Buddhist Hospital, The Queen Elizabeth Hospital
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 24 Jul 2023 (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.
Knee osteoarthritis (OA) is the most common form of arthritis and is the leading cause of chronic musculoskeletal pain and functional disability. Gait assessment is essential for the rehabilitation of people with knee OA. It may reflect the impact of knee OA on functional outcomes and allow prediction of prognosis for patients. Various people with knee OA may demonstrate different forms of gait asymmetry owing to his/her own knee pain experienced and joint instability perceived. The stance time, peak vertical and peak propulsive ground reaction force have found to be significantly reduced on the OA affected limb. People with knee OA demonstrate compensatory gait pattern to minimize joint loading. It is quite common that the severity of the OA symptoms varies in the two knees, and patients may demonstrate various forms of gait asymmetries, such changes in gait biomechanics does not only impact the affected knee joint. Its impact extends proximally along the kinetic chain system of the human body, where often knee OA patients presents with significantly increased lateral trunk flexion towards ipsilateral limb during walking.
Gait asymmetry as a result of knee OA has been constantly reported in both human and animal studies. Previous studies showed that people with unilateral knee symptoms may adapt to asymmetrical movement patterns, which results in reduced net knee extension demand moments Research interest on gait asymmetry has been expanded to other cohort of patients, e.g. hemiplegic stroke patients. Extensive evidence has shown that the modification of walking speed has a positive impact on the propulsive force of hemiplegic patient's affected limb. These encouraging results have form indications for future investigation on evaluating the impact of innovative gait training in promoting symmetrical gait pattern, targeting patients with unilateral knee OA or bilateral knee OA of different severity. The objective to assess knee OA's gait under different walking conditions is now feasible with the access to the dualbelt treadmill at PolyU. In addition to walking speed modification, emerging backward walking as part of gait training rehabilitation in knee OA patients has become increasingly popular. Backward walking is regulated by the same central pattern generator as forward walking; however, it does not require initial heel contact in early stance phase of the gait cycle as it would be in forward walking. This leads to reduced compression force at the patella-femoral joint and decreased force absorption imposed at the knee joint. Recent systematic review and meta-analysis have suggested combining backward walking to conventional physiotherapy has significantly improve clinical outcomes, including pain control, functional disability, muscle strength, gait pattern, balance and postural stability in knee OA patients.
All of above-mentioned findings have highlighted the connection between specific gait parameters and clinical outcomes, and also the importance of monitoring these changes as disease naturally progress. It is also vital to note the benefits of emerging technologies as the implementation of novel strategies can optimize the ambulatory capacity of the individual, which therefore enhance their recovery potential and quality of life.
Detailed description
This study is a two-armed, parallel group, single centered randomized controlled trial investigating the efficacy of gait training combined with conventional treatment as compared to conventional treatment alone in post-TKR rehabilitation program. Potential participants will be recruited from BH and QEH, where patients with confirmed diagnosis of K\&L grade 2 to 4 knee OA who have received TKR will be eligible for this study. Subjects with prior history of knee surgery, impaired lower limb function other than knee joint or has previously received an intra-articular injection to knee will be excluded from the study to ensure validity of results. It aims to compare and evaluate the effectiveness of combined conventional rehabilitation with gait training on dual-belt treadmill and conventional rehabilitation alone on post-operative clinical outcomes and gait pattern.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Gait training programParticipants in the intervention group will receive a weekly gait training program at PolyU in addition to conventional treatment at Outpatient Patient Department (OPD) of The Hong Kong Buddhist Hospital twice per week for 4 consecutive weeks. Gait training program at PolyU is a supervised rehabilitation program performed on the dual-belt treadmill. |
| Control Group | Active comparator | Behavioral: Conventional training onlyParticipants in control group will only receive conventional treatment at Outpatient Patient Department (OPD) of BH twice per week for 4 consecutive weeks. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Potential participants will be recruited from BH and QEH, where patients with confirmed diagnosis of K\&L grade 2 to 4 knee OA who have received TKR will be eligible for this study.
Key exclusion criteria (1 listed)
- Subjects with prior history of knee surgery, impaired lower limb function other than knee joint or has previously received an intra-articular injection to knee will be excluded from the study to ensure validity of results.
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 |
|---|---|---|
| Gait training programGait training program at PolyU is a supervised rehabilitation program performed on the dual-belt treadmill. It consists of forward walking at increased speed over the affected leg and retro walking (backward walking) at individual's own pace (5 minutes/set for three sets, with rest periods in each session). This program also consists of a standardized set of warm-up and cool-down exercises at each training session. Participants will also receive conventional physiotherapy treatment in the outpatient physiotherapy clinic. | Behavioural | Intervention Group |
| Conventional training onlyConventional physiotherapy treatment in the outpatient physiotherapy clinic. | Behavioural | Control Group |
Primary outcome
Western Ontario and McMaster Universities Arthritis Index
Time frame: pre-operative session (T1)
Pain intensity, stiffness and function of the operated knee will be assessed using the Western Ontario and McMaster Universities Arthritis Index. Minimum：0 Maximum：96 Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Western Ontario and McMaster Universities Arthritis Index
Time frame: two-weeks post-operation (T2)
Pain intensity, stiffness and function of the operated knee will be assessed using the Western Ontario and McMaster Universities Arthritis Index. Minimum：0 Maximum：96 Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Western Ontario and McMaster Universities Arthritis Index
Time frame: six-weeks post-operation(T3)
Pain intensity, stiffness and function of the operated knee will be assessed using the Western Ontario and McMaster Universities Arthritis Index. Minimum：0 Maximum：96 Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Western Ontario and McMaster Universities Arthritis Index
Time frame: six-month follow-up
Pain intensity, stiffness and function of the operated knee will be assessed using the Western Ontario and McMaster Universities Arthritis Index. Minimum：0 Maximum：96 Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
36 secondary outcomes
30s Chair-Stand Test
Time frame: pre-operative session (T1)
30s Chair-Stand Test
Time frame: two-weeks post-operation (T2)
30s Chair-Stand Test
Time frame: six-weeks post-operation(T3)
30s Chair-Stand Test
Time frame: six-month follow-up
40-m Fast-Paced Walk Test
Time frame: pre-operative session (T1)
40-m Fast-Paced Walk Test
Time frame: two-weeks post-operation (T2)
40-m Fast-Paced Walk Test
Time frame: six-weeks post-operation(T3)
40-m Fast-Paced Walk Test
Time frame: six-month follow-up
Stair-Climb Test
Time frame: pre-operative session (T1)
Stair-Climb Test
Time frame: two-weeks post-operation (T2)
Stair-Climb Test
Time frame: six-weeks post-operation(T3)
Stair-Climb Test
Time frame: six-month follow-up
Timed Up-and-Go Test
Time frame: pre-operative session (T1)
Timed Up-and-Go Test
Time frame: two-weeks post-operation (T2)
Timed Up-and-Go Test
Time frame: six-weeks post-operation(T3)
Timed Up-and-Go Test
Time frame: six-month follow-up
6-min Walk Test
Time frame: pre-operative session (T1)
6-min Walk Test
Time frame: two-weeks post-operation (T2)
6-min Walk Test
Time frame: six-weeks post-operation(T3)
6-min Walk Test
Time frame: six-month follow-up
Step Length Asymmetry
Time frame: pre-operative session (T1)
Step Length Asymmetry
Time frame: two-weeks post-operation (T2)
Step Length Asymmetry
Time frame: six-weeks post-operation(T3)
Step Length Asymmetry
Time frame: six-month follow-up
Knee Moment
Time frame: pre-operative session (T1)
Knee Moment
Time frame: two-weeks post-operation (T2)
Knee Moment
Time frame: six-weeks post-operation(T3)
Knee Moment
Time frame: six-month follow-up
Ground Reaction Force
Time frame: pre-operative session (T1)
Ground Reaction Force
Time frame: two-weeks post-operation (T2)
Ground Reaction Force
Time frame: six-weeks post-operation(T3)
Ground Reaction Force
Time frame: six-month follow-up
Osteoarthritis Fears and Beliefs Questionnaire (KOBeQ)
Time frame: pre-operative session (T1)
Osteoarthritis Fears and Beliefs Questionnaire (KOBeQ)
Time frame: two-weeks post-operation (T2)
Osteoarthritis Fears and Beliefs Questionnaire (KOBeQ)
Time frame: six-weeks post-operation(T3)
Osteoarthritis Fears and Beliefs Questionnaire (KOBeQ)
Time frame: six-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait training program and Conventional training only in people with Total Knee Replacement, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 1 inclusion and 1 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 24 Jul 2023. 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 Hong Kong. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster Universities Arthritis Index (time frame: pre-operative session (T1)). The study lists 4 primary outcomes in all. 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 24 Jul 2023.