Shoulder OsteoarthritisSIP_LaFeNCT06153381
Virtual Rehabilitation Assistant Via Instant Messaging Communication to Promote Adherence to Rehabilitation After Reverse Shoulder Replacement
A study testing Chatbot and Standard car in people with Shoulder Osteoarthritis, run by University of Valencia at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Shoulder Osteoarthritis
- What is being tested?
- Chatbot and Standard car
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, 46026
Marta Navarro, MD, 961 24 40 00, mnb18504@gmail.com
About this study
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)
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
Read the detailed 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
- Conditions
- Shoulder Osteoarthritis
- Being tested
- Chatbot, Standard car
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChatbotOther
Rehabilitation program based on standard care, but assisted via an instant messaging application using a personal smartphone
Standard carOther
Rehabilitation program based on standard care, assisted with one education session plus informative brochure
| Study group | Role | What they receive |
|---|---|---|
| Chatbot care | Experimental | Not described Receives: Other: Chatbot; Other: Standard car |
| Standard care | Active comparator | Not described Receives: Other: Standard car |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 weeks, 12 weeks
Secondary outcomes (4)
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
Measured: 0 weeks, 12 weeks
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?
Measured: 0 weeks, 12 weeks
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'.
Measured: 0 weeks, 12 weeks
Number of sessions of rehabilitation completed
Compliance with rehabilitation, measuring the number of sessions completed
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start1 Sep 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario La Fe
- Responsible party
- Principal investigator, Jose María Blasco Igual, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153381
- Sponsor's protocol ID
- SIP_LaFe
- Acronym
- SIP_LaFe
- Status last verified
- Dec 2023
- First submitted
- 22 Nov 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06153381
- Acronym / sponsor ID
- SIP_LaFe / SIP_LaFe
- Conditions
- Shoulder Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Hospital Universitario La Fe
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chatbot care | Experimental | Other: Chatbot, Other: Standard car |
| Standard care | Active comparator | Other: Standard car |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChatbotRehabilitation program based on standard care, but assisted via an instant messaging application using a personal smartphone | Other | Chatbot care |
| Standard carRehabilitation program based on standard care, assisted with one education session plus informative brochure | Other | Chatbot care, Standard care |
Primary outcome
Shoulder disability
Time frame: 0 weeks, 12 weeks
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.
4 secondary outcomes
Shoulder functionality
Time frame: 0 weeks, 12 weeks
Shoulder pain
Time frame: 0 weeks, 12 weeks
Quality of Life
Time frame: 0 weeks, 12 weeks
Number of sessions of rehabilitation completed
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chatbot and Standard car in people with Shoulder Osteoarthritis, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder disability (time frame: 0 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.