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

NCT05958212 | Unknown

• 1 other identifier: 2021-0212
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Replacement

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  six-month follow-up

Secondary Outcomes (36)

• 30s Chair-Stand Test

  pre-operative session (T1)

• 30s Chair-Stand Test

  two-weeks post-operation (T2)

• 30s Chair-Stand Test

  six-weeks post-operation(T3)

• 30s Chair-Stand Test

  six-month follow-up

• 40-m Fast-Paced Walk Test

  pre-operative session (T1)

Study Arms (2)

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.

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.

Behavioral: Conventional training only

Interventions

Gait training program 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.

Intervention Group

Conventional training only BEHAVIORAL

Conventional physiotherapy treatment in the outpatient physiotherapy clinic.

Control Group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• The Hong Kong Buddhist Hospital: collaborator
• The Queen Elizabeth Hospital: collaborator

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: July 24, 2023
• Study Start: June 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)