Virtual Rehabilitation Assistant Via Instant Messaging Communication to Promote Adherence to Rehabilitation After Reverse Shoulder Replacement

Shoulder Osteoarthritis Clinical Trial

— SIP_LaFe  

Official title:

Herramienta de Procesamiento de Lenguaje Natural en Dispositivo móvil Inteligente Para Asegurar la Adherencia a la rehabilitación Domiciliaria en cirugías de Artroplastia Invertida de Hombro (NLP-PTAdherence)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06153381
• Other study ID #: SIP_LaFe
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: December 2023
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

reverse shoulder replacement surgery is performed to improve the functionality and reduce pain of the affected shoulder. Now, it is necessary to carry out an appropriate rehabilitation process to optimize surgical results. The lack of health resources makes it essential for the patient to work autonomously once hospital rehabilitation is completed. But lack of adherence is one of the main barriers to recovery

Description:

The objective is to evaluate the effectiveness of a Chatbot that interacts with patients via instant messaging to supervise home rehabilitation and increase adherence. Conduct a feasibility study with a pilot sample

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients undergoing reverse shoulder replacement

• With a personal smartphone

• An instant messaging application installed

• Familiar with the use of such an application (i.e., at least three accessess per week)

• Able to write and read in the Spanish language

Exclusion Criteria:

• Condition, whether cognitive, neurological, integrative or musculoskeletal, that obviously prevents understanding or performing the exercises of the rehabilitation program or may pose a risk to the patient's health.

Related Conditions & MeSH terms

• Osteoarthritis
• Shoulder Osteoarthritis

Intervention

Other:
• Chatbot
Rehabilitation program based on standard care, but assisted via an instant messaging application using a personal smartphone
• Standard car
Rehabilitation program based on standard care, assisted with one education session plus informative brochure

Locations

Country	Name	City	State
Spain	Hospital Universitario y Politécnico La Fe	València	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
University of Valencia	Hospital Universitario La Fe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder disability	This is measured with the Quick Dash questionnaire, a self-reported survey of 11 items designed to assess symptoms and ability to perform certain activities. At least 10 items should be answered to calculate a score. Each answer can be scored from one to five, and the average value is calculated, thus obtaining a score from one to five. Then, to express the score in percentages, 1 is subtracted from the result and then multiplied by 25. The higher the score, the greater the disability.	0 weeks, 12 weeks
Secondary	Shoulder functionality	measured with the Constant-Murley Score, a multi-item functional scale assessing pain, ADL, ROM and strength of the affected shoulder. Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively	0 weeks, 12 weeks
Secondary	Shoulder pain	Assessed with a numeric pain rating scale, ranging from 0, the worst possible pain, to 10, no pain, with the question: What was your overall pain in the shoulder in the last week?	0 weeks, 12 weeks
Secondary	Quality of Life	measured with the EQ-5D-5L quetionnaire, which essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.	0 weeks, 12 weeks
Secondary	Number of sessions of rehabilitation completed	Compliance with rehabilitation, measuring the number of sessions completed	12 weeks