Knee Osteoarthritis
Conditions
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).
Interventions
OTHERChatbot Assistant
The physiotherpy treatment will be supervised via chatbot
OTHERStandard care
The physiotherpy treatment will be standard care
Sponsors
Ministerio de Ciencia e Innovación, Spain
University of Valencia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence | 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
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 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 |
| Knee Pain | 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
| Measure | Time frame | Description |
|---|---|---|
| International Physical Activity Questionnaire (IPAQ-E) | 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 |
| Safety | Baseline (surgery day) to 12 months | Adverse events, defined as any unfavorable or unintended diagnosis, sign, symptom, or disease associated with the study |
| System Usability | 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 |
| Feasibility_1 | 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 |
| Feasibility_2 | 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 |
Countries
Spain
Outcome results
None listed