Lower Knee Joint Loading by Real-time Biofeedback Stair Walking Rehabilitation for Patients With MCKOA

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, 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.

Conditions

• Knee Osteoarthritis

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• City University of Hong Kong

  collaborator OTHER

• Chinese University of Hong Kong

  collaborator OTHER

• Bern University of Applied Sciences

  collaborator OTHER

• The Hong Kong Polytechnic University

  lead OTHER

Principal Investigators

• Roy TH CHEUNG, PhD · The Hong Kong Polytechnic University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-01

Primary Completion

2022-12-30

Completion

2023-12-30

Countries

• China

Study Locations