Clinical trial NCT05958212: Innovative Gait Training for People With Knee Osteoarthritis Using Dual Belt Treadmill
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Total Knee Replacement
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: The Hong Kong Buddhist Hospital
name: The Queen Elizabeth Hospital
First posted: 2023-07-24
Enrollment: 54
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Western Ontario and McMaster Universities Arthritis Index
timeFrame: pre-operative session (T1)
measure: Western Ontario and McMaster Universities Arthritis Index
timeFrame: two-weeks post-operation (T2)
measure: Western Ontario and McMaster Universities Arthritis Index
timeFrame: six-weeks post-operation(T3)
measure: Western Ontario and McMaster Universities Arthritis Index
timeFrame: six-month follow-up
Secondary outcomes:
measure: 30s Chair-Stand Test
timeFrame: pre-operative session (T1)
measure: 30s Chair-Stand Test
timeFrame: two-weeks post-operation (T2)
measure: 30s Chair-Stand Test
timeFrame: six-weeks post-operation(T3)
measure: 30s Chair-Stand Test
timeFrame: six-month follow-up
measure: 40-m Fast-Paced Walk Test
timeFrame: pre-operative session (T1)
measure: 40-m Fast-Paced Walk Test
timeFrame: two-weeks post-operation (T2)
measure: 40-m Fast-Paced Walk Test
timeFrame: six-weeks post-operation(T3)
measure: 40-m Fast-Paced Walk Test
timeFrame: six-month follow-up
measure: Stair-Climb Test
timeFrame: pre-operative session (T1)
measure: Stair-Climb Test
timeFrame: two-weeks post-operation (T2)
measure: Stair-Climb Test
timeFrame: six-weeks post-operation(T3)
measure: Stair-Climb Test
timeFrame: six-month follow-up
measure: Timed Up-and-Go Test
timeFrame: pre-operative session (T1)
measure: Timed Up-and-Go Test
timeFrame: two-weeks post-operation (T2)
measure: Timed Up-and-Go Test
timeFrame: six-weeks post-operation(T3)
measure: Timed Up-and-Go Test
timeFrame: six-month follow-up
measure: 6-min Walk Test
timeFrame: pre-operative session (T1)
measure: 6-min Walk Test
timeFrame: two-weeks post-operation (T2)
measure: 6-min Walk Test
timeFrame: six-weeks post-operation(T3)
measure: 6-min Walk Test
timeFrame: six-month follow-up
measure: Step Length Asymmetry
timeFrame: pre-operative session (T1)
measure: Step Length Asymmetry
timeFrame: two-weeks post-operation (T2)
measure: Step Length Asymmetry
timeFrame: six-weeks post-operation(T3)
measure: Step Length Asymmetry
timeFrame: six-month follow-up
measure: Knee Moment
timeFrame: pre-operative session (T1)
measure: Knee Moment
timeFrame: two-weeks post-operation (T2)
measure: Knee Moment
timeFrame: six-weeks post-operation(T3)
measure: Knee Moment
timeFrame: six-month follow-up
measure: Ground Reaction Force
timeFrame: pre-operative session (T1)
measure: Ground Reaction Force
timeFrame: two-weeks post-operation (T2)
measure: Ground Reaction Force
timeFrame: six-weeks post-operation(T3)
measure: Ground Reaction Force
timeFrame: six-month follow-up
measure: Osteoarthritis Fears and Beliefs Questionnaire (KOBeQ)
timeFrame: pre-operative session (T1)
measure: Osteoarthritis Fears and Beliefs Questionnaire (KOBeQ)
timeFrame: two-weeks post-operation (T2)
measure: Osteoarthritis Fears and Beliefs Questionnaire (KOBeQ)
timeFrame: six-weeks post-operation(T3)
measure: Osteoarthritis Fears and Beliefs Questionnaire (KOBeQ)
timeFrame: six-month follow-up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
References: