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

February 10, 2020 updated by: Dr Roy Tsz-hei CHEUNG, The Hong Kong Polytechnic University

Lower Knee Joint Loading by Real-time Biofeedback Stair Walking Rehabilitation for Patients With Medial Compartment Knee Osteoarthritis

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Conventionally, gait retraining is necessarily implemented in a laboratory environment because evaluation of biomechanical markers, such as KAM, requires sophisticated motion capturing system and force plates. With advancement of wearable sensor technology, it is possible to measure gait biomechanics and provide real time biofeedback for gait retraining using inertial measurement unit (IMU), which is a lightweight and portable wireless device. In an ongoing government funded project, the investigators have developed IMU embedded footwear that measures KAM during level ground walking. The investigators have compared Least Absolute Shrinkage and Selection Operator (LASSO) regression and Random Forest in the prediction of KAM from IMU recordings. The investigators found that Random Forest could provide much higher KAM prediction accuracy than LASSO regression. The agreement between conventional laboratory-based and sensor-based measurement of KAM was approximately 90%. Based on investigators' previous research work, it is meaningful to extend the newly developed technology for KAM measurement during stair ascent and descent without the use of laboratory equipment. With the wearable sensors connected to the smartphones, gait retraining outside laboratory environment will become feasible but the effects of gait retraining using wearable sensors have not been directly verified.

Given these considerations, this project has two primary aims. The investigators will: (1) first establish a machine-learning algorithm to predict KAM using IMU sensors during stair ascent and descent; and then (2) 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).

Primary hypothesis

Hypothesis 1: 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.

Hypothesis 2: 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.

Study Type

Interventional

Enrollment (Anticipated)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 45-80 years of age;
  2. patients with early medial compartment knee OA (Kellgren & Lawrence grade = 1 or 2);
  3. self-reported knee pain at least once per week for the proceeding eight weeks;
  4. patients should be able to walk unaided for at least 60 minutes.

Exclusion Criteria:

  1. have a body mass index >35;
  2. have a known learning disability;
  3. use a shoe insert or knee brace;
  4. have received corticosteroid injection within the previous eight weeks;
  5. have absolute contraindications for vigorous physical activities according to the American College of Sports Medicine;
  6. in order to avoid floor effect of training, all subjects will undergo an initial screening and only those with KAM greater than 0.3 Nm/kg during level ground walking will be invited into the retraining study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laboratory-based gait retraining (LGR)
Subjects will attend 6 weekly sessions of stair ascent and descent exercise over six consecutive weeks. In each session, they walk at a self-selected speed on the instrumented staircase. The training time will be progressively increased from 15 to 30 minutes over the six sessions. The auditory feedback will be gradually removed in the last three sessions.
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.
Experimental: Sensor-based gait retraining (SGR)
Subjects will receive training similar to LGR, except the KAM measurement is based solely on inputs from IMUs embedded in the shoes. The training schedule, duration, and intensity will be identical to those of the LGR group.
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.
Experimental: Walking exercise control (Ctrl)
Subjects will attend 6 weekly sessions of stair ascent and descent exercise over six consecutive weeks. In each session, they 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in knee adduction moment (KAM)
Time Frame: baseline and 7 weeks
The surrogate marker of the medial compartment knee joint loading (i.e. KAM) will be measured by a 10-camera motion capture system (Vicon, Oxford Metrics Group, Oxford, UK) at 100 Hz and an instrumented staircase equipped with two force plates (Bertec, Columbus, OH, USA) at 1000Hz during stair ascent and descent at baseline assessment and after 6-week stair retraining.
baseline and 7 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Chinese Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: baseline and 7 weeks
The Chinese Knee Injury and Osteoarthritis Outcome Score (KOOS) will be used to assess knee pain, symptoms and physical function of the patients before and after stair retraining. This instrument contains 42 items addressing pain, symptoms, activities of daily living, sports and recreational function, and knee-related quality of life. The total score and sub-score for each domain (pain, symptoms, activities of daily living, sports/ recreational function, and knee-related quality of life) will be normalized from 0 to 100, with 100 indicating the worst possible state, 0 indicating no pain or loss of function.
baseline and 7 weeks
Chnage in validated visual analogue scale (VAS)
Time Frame: basleline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks and 7 weeks
The validated visual analogue scale (VAS) of 100 mm will be used to assess overall knee pain level after each stair negotiation session, with 0 mm at the left-most end of the 100 mm scale indicating"No pain at all" and 100 mm at the right-most end indicating"Worst imaginable pain".
basleline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks and 7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Collaborators

Chinese University of Hong Kong
City University of Hong Kong
Bern University of Applied Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2021

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

November 6, 2018

First Submitted That Met QC Criteria

November 6, 2018

First Posted (Actual)

November 8, 2018

Study Record Updates

Last Update Posted (Actual)

February 11, 2020

Last Update Submitted That Met QC Criteria

February 10, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSEARS20181031005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Knee Osteoarthritis

Clinical Trials on Laboratory-based gait retraining (LGR)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe