NCT05363137

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 5, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

March 4, 2025

Status Verified

September 1, 2022

Enrollment Period

9 months

First QC Date

May 2, 2022

Last Update Submit

February 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Adherence

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

    Change from baseline to 3 months after surgery date

Secondary Outcomes (2)

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

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

  • Knee Pain

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

Other Outcomes (5)

  • Safety

    Baseline (surgery day) to 12 months

  • Feasibility_1

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

  • Feasibility_2

    Time from initial day to 3 months after surgery date

  • +2 more other outcomes

Study Arms (2)

Experimental

EXPERIMENTAL
Other: Chatbot Assistant

Control

ACTIVE COMPARATOR
Other: Standard care

Interventions

The physiotherpy treatment will be supervised via chatbot

Experimental

The physiotherpy treatment will be standard care

Control

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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),

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital La Fe

Valencia, Valencia, 46026, Spain

Location

Related Publications (1)

  • Blasco JM, Diaz-Diaz B, Igual-Camacho C, Perez-Maletzki J, Hernandez-Guilen D, Roig-Casasus S. Effectiveness of using a chatbot to promote adherence to home physiotherapy after total knee replacement, rationale and design of a randomized clinical trial. BMC Musculoskelet Disord. 2023 Jun 15;24(1):491. doi: 10.1186/s12891-023-06607-3.

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 2, 2022

First Posted

May 5, 2022

Study Start

September 1, 2022

Primary Completion

June 1, 2023

Study Completion

June 1, 2024

Last Updated

March 4, 2025

Record last verified: 2022-09

Locations