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OpenTrials
Completed

NCT Number: NCT05363137

Effectiveness of Using a Chatbot to Promote Adherence to Home Physiotherapy

A Chatbot oriented to virtually assist patients in a physiotherapy treatment has been designed and developed to interact with patients with musculoskeletal disorders in need for domiciliary rehabilitation. The tool has been designed to promote adherence to rehabilitation, what in turn may have an impact on clinical outcome. A randomized clinical trial involving patients undergoing total knee replacement has bee designed to determine the applicability of the proposal. The participants will be assigned into exerimental group (intervention with the software tool) or control group (standard care).

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

Up to 75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital La Fe

Valencia, 46026, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals on the waiting list for total knee replacement surgery
  • Undergoing primary total knee replacement surgery
  • Who have a personal smartphone
  • Who have an instant messaging application installed
  • Familiar with the use of such application (more than 3 accesses per week),

Exclusion criteria

  • Evident cognitive state that prevents to understand care provider instructions
  • Vestibular or central nervous system affection (e.g. stroke)
  • Cannot read or write
  • Do not understand Spanish language
  • Not able to consent to participate

Treatment and study plan

Chatbot Assistant

Other

The physiotherpy treatment will be supervised via chatbot

Standard care

Other

The physiotherpy treatment will be standard care

Primary outcomes

  1. Adherence

    Time frame: Change from baseline to 3 months after surgery date

    Compliance with intervention measured as the percentage of sessions carried out with respect to the total planned

Secondary outcomes

  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: Change from baseline to 3 months and one year after surgery date

    Self-administered questionnaire consisting of 24 items divided into pain, stiffness and physical function will register self-reported status. The score is given from 0 to 100

  2. Knee Pain

    Time frame: Change from baseline to 3 months and one year after surgery date

    Measured with a visual analogue scale of pain, being 0 no pain and 10 the worst possible pain

Other outcomes

  1. Safety

    Time frame: Baseline (surgery day) to 12 months

    Adverse events, defined as any unfavorable or unintended diagnosis, sign, symptom, or disease associated with the study

  2. Feasibility_1

    Time frame: Time from initial day to last day of recruitment up to two years

    Recruitment rate, obtained by dividing the number of participants divided by the number patients invited

  3. Feasibility_2

    Time frame: Time from initial day to 3 months after surgery date

    Retention rate, obtained by dividing the number of participants assessed at three months by the total number of participants

  4. International Physical Activity Questionnaire (IPAQ-E)

    Time frame: Change from baseline to 3 months after surgery date

    This questionnaire is used to measure the types of intensity of physical activity and sitting time as part of the participants' daily lives, i.e. the total physical activity in MET-min/week and time spent sitting

  5. System Usability

    Time frame: Change from baseline to 3 months after surgery date

    System usability scale will be used for measuring the usability; this consists of a 10 item questionnaire with five response options from Strongly agree to Strongly disagree

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Collaborators

  • Ministerio de Ciencia e Innovación, Spain

Registry information

Official study title

Herramienta De Procesamiento De Lenguaje Natural En Dispositivo Móvil Inteligente Para Fomentar La Adherencia a La Rehabilitación Domiciliaria

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 5, 2022
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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