Innovative Gait Training for People With Knee Osteoarthritis Using Dual Belt Treadmill

NCT ID: NCT05958212

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2025-06-01

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.

Conditions

Total Knee Replacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

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.

Group Type: EXPERIMENTAL

Gait training program

Intervention Type: BEHAVIORAL

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.

Control Group

Participants in control group will only receive conventional treatment at Outpatient Patient Department (OPD) of BH twice per week for 4 consecutive weeks.

Group Type: ACTIVE_COMPARATOR

Conventional training only

Intervention Type: BEHAVIORAL

Conventional physiotherapy treatment in the outpatient physiotherapy clinic.

Interventions

Gait training program

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.

Intervention Type: BEHAVIORAL

Conventional training only

Conventional physiotherapy treatment in the outpatient physiotherapy clinic.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Hong Kong Buddhist Hospital

UNKNOWN

Sponsor Role: collaborator

The Queen Elizabeth Hospital

OTHER

Sponsor Role: collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Dr Patrick Kwong

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

2021-0212

Identifier Type: -

Identifier Source: org_study_id