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The Kaia Hip and Knee Pain Intervention for Self-management of the Pain in Patients With Osteoarthritis.

NCT04615377 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2022-08-16

No results posted yet for this study

Summary

The study intervention provides an innovative way of making exercise training and other recommended lifestyle modifications as accessible as possible for knee and hip OA participants by introducing a home-based exercise training program with a motion track feedback technology. Self-management of the pain for the patients suffering osteoarthritis, in the form of lifestyle modification, implementation of coping strategies and exercise is part of recommendations of recent international guidelines such as those by the Osteoarthritis Research Society International (OARSI). Cost and resource constraints typically limit the access to these recommended therapies. Moreover, the study intervention is focused on maintaining and adapting everyday physical activity, as required, in comparison to the control group.

Conditions

Interventions

BEHAVIORAL

Kaia hip and knee pain application

The Kaia Knee and Hip pain app software, when loaded onto a smartphone, recommends to the participant specific exercises for the lower extremity. Using the camera on a smartphone, the software then tracks the participant's movements as the participant performs the exercises, analyzes those movements using machine learning, and provides audio-visual feedback to the participant. The exercise therapy is augmented by educational content and cognitive behavioral therapy to provide a multidisciplinary approach to self-management of osteoarthritis. Behavioral Health Coaches ensure participant motivation throughout the program based on a predefined curriculum.

OTHER

Treatment as usual

Participants allocated to the control arm will be advised to continue receiving treatment as usual ( standard care) without restrictions, except participation in other investigational trials, and will likewise be followed up for 90 days. Apart from that, they are encouraged to seek care, as they would do normally.

Sponsors & Collaborators

  • Kaia Health Software

    lead INDUSTRY

Principal Investigators

  • Kevin J Choo, MD · Orthopaedic and Neurosurgery Specialists, 6 Greenwich Office Park, Greenwich, CT 06831

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-07
Primary Completion
2021-07-31
Completion
2021-09-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04615377 on ClinicalTrials.gov