An observational study in Anterior Cruciate Ligament Reconstruction, sponsored by University of Évora. Not yet recruiting. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-11-30.
Sponsored by University of Évora · Observational
The main goal of this trial is to determine the feasibility of a randomized controlled trial for the Knee Care at Home Programme, rather than the effectiveness, for patients recovering from anterior cruciate ligament reconstruction. Specifically, the trial aims to: (1) assess the feasibility of studying the effectiveness of the Knee Care at Home programme, including patient engagement and satisfaction; and (2) conduct a qualitative assessment to identify barriers and facilitators in the implementation and delivery of the programme.
Participants will be asked to take part in a 22-week intervention within a 24-week postoperative rehabilitation period following anterior cruciate ligament reconstruction. Internet-based remote sessions (3 times a week, 40 minutes per session) will supplement conventional clinic-based rehabilitation (face-to-face sessions). After the anterior cruciate ligament reconstruction, outcome measures are assessed during consultations with the orthopedic surgeon. These consultations occur after 4 weeks of intervention interval, except for the second postoperative consultation which occurs after a 2-week intervention period interval. Additional evaluations will occur during each remote session.
The team of researchers will evaluate the enrollment (screening, informed consent, eligibility, and allocation), data collection (response rates, missing data, and implementation and technical issues), intervention fidelity (adherence, adherence rate at remote sessions, adherence at conventional rehabilitation, quality of delivery, participant responsiveness, and safety), and acceptability (patient satisfaction and motivation).
University of Évora is the lead sponsor of 34 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who have undergone anterior cruciate ligament reconstruction at Hospital da Misericórdia de Évora.
Exclusion Criteria
Individualised clinic-based face-to-face sessions with a physiotherapist in public or private rehabilitation facility
Individualised synchronous internet-based remote sessions at home via conferencing software under the supervision of a certified exercise and health coach as a complement to conventional clinic-based rehabilitation sessions.
Other: Knee Care @Home Programme
Over 24 weeks after undergoing surgical reconstruction of the anterior cruciate ligament, patients in the intervention group will receive supervised guidance on therapeutic exercises to be performed at home. This guidance will be provided through individualised synchronous internet-based remote sessions using conferencing software.
Also known as: Synchronous internet-based remote sessions, Therapeutic Exercises
Enrolment: Screening
Quantitative data: The number of patients with anterior cruciate ligament injury who were approached and scheduled for anterior cruciate ligament reconstruction. Qualitative data: Open-ended questions posed to the orthopaedic surgeon regarding any ambiguities surrounding the screening procedure.
Time frame: Preoperative consultation
Enrolment: Informed Consent
Quantitative data: The number of patients who have signed the informed consent. Qualitative data: Open-ended questions posed to patients regarding their reasons for not signing the consent form.
Time frame: Preoperative consultation
Enrolment: Eligibility
Quantitative data: (1) The number of patients assessed for eligibility; (2) The number of patients meeting the inclusion criteria; and (3) The number of patients included. Qualitative data: (1) Open-ended questions to patients about the reasons for not participating; and (2) Open-ended question to orthopaedic surgeons about the reasons for patient ineligibility and enrollment ambiguities.
Time frame: First consultation after surgery (second week)
Enrolment: Allocation
Quantitative data: (1) The number of patients who agreed to be randomly assigned; and (2) The number of patients who dropped out after randomisation. Qualitative data: (1) Open-ended questions to patients about any problems they experienced with randomisation; and (2) Open-ended questions to orthopaedic surgeons about their reluctance to randomise patients.
Time frame: First consultation after surgery (second week)
Data Collection: Response rates
Quantitative data includes the total number of outcome evaluation tools, the minutes spent using evaluation tools, and the number of unusable outcome measures.
Time frame: Up to 36 weeks postoperative
Data Collection: Missing data
Quantitative data includes the number of missing items.
Time frame: Up to 36 weeks postoperative
Data Collection: Implementation and Technical issues
Quantitative data: (1) Assessment of the costs and time allocated to resolving technical issues; and (2) Determination of the quantity of exercise and health coaches required to oversee patient recovery. Qualitative data: (1) Open-ended questions to patients regarding any technical issues encountered during remote sessions; and (2) Open-ended questions to exercise and health coaches regarding the adequacy of resources for remote sessions.
Time frame: During each remote session, there will be a total of 22 weeks with 42 sessions between the 2nd and 24th postoperative week.
Intervention Fidelity: Adherence to the trial
Patients will be assessed in three areas: \[1\] withdrawal rate, including the number of patients who completed at least one remote session and then decided to withdraw, as well as the time point of withdrawal decision (quantitative data), and open-ended questions to those who withdraw to explain their reasons (qualitative data); \[2\] completion rate, which measures the number of patients that attend all remote sessions and consultations (quantitative data); and \[3\] follow-up rate, which measures the number of patients who remained in the study throughout the intervention period as a proportion of the total number of participants recruited at baseline (quantitative data).
Time frame: During each orthopaedic consultation, there will be a total of 7 consultations on the 2nd, 4th, 8th, 12th, 16th, 20th, and 24th postoperative weeks, spanning a total of 22 weeks.
Intervention Fidelity: Adherence rate at Remote sessions
Areas: (1) General; (2) Consultations; (3) Compliance; and (4) Dosage. 1. Open-ended questions will be asked to participants and coaches about reasons for absence from remote sessions (qualitative data). 2. Data will be collected on completed evaluation consultations and duration (quantitative data). Open-ended questions will be asked to patients, surgeons, and assessors about reasons for non-compliance with evaluation consultations (qualitative data). 3. Data will be collected on attendance, cancellations, lateness, logins, and completed remote sessions (quantitative data). Patient log sheets will be evaluated for qualitative data. 4. Data will be collected on completed remote sessions, session parameters, exercises, and costs (quantitative data).
Time frame: During each remote session, there will be a total of 22 weeks with 42 sessions between the 2nd and 24th postoperative week.
Intervention Fidelity: Adherence rate at Conventional Clinic-based Rehabilitation
Quantitative data: (1) Determine the number of patients participating in conventional clinic-based rehabilitation; (2) Track the number of sessions per week and their duration; and (3) Calculate the indirect costs associated with conducting the sessions. Qualitative Data: Open-ended questions posed to patients to gather information about the reasons for their absence from conventional clinic-based rehabilitation.
Time frame: During each orthopaedic consultation, there will be a total of 7 consultations on the 2nd, 4th, 8th, 12th, 16th, 20th, and 24th postoperative weeks, spanning a total of 22 weeks.
Intervention Fidelity: Quality of delivery
Quantitative data: Questions about the exercise and health coach's capacity to deliver the remote sessions. Qualitative data: Application of a questionnaire on an ordinal scale to patients about their self-rated level of agreement to statements about the exercise program using an 11-point Numeric Rating Scale (0 = strongly disagree and 10 = strongly agree).
Time frame: During each orthopaedic consultation, there will be a total of 7 consultations on the 2nd, 4th, 8th, 12th, 16th, 20th, and 24th postoperative weeks, spanning a total of 22 weeks.
Intervention Fidelity: Participant Responsiveness
Quantitative data: (1) The number of exercises the patient was able to complete; and (2) The level of interest of patients in remote sessions based on previous criteria. Qualitative data: Application of a questionnaire on an ordinal scale to exercise and health coaches about their perception of the participant's effort during the remote sessions (SIRAS Scale).
Time frame: During each remote session, there will be a total of 22 weeks with 42 sessions between the 2nd and 24th postoperative week.
Intervention Fidelity: Safety (adverse events)
Quantitative data: (1) Assessing the frequency of signs and symptoms during remote sessions and between consultations; (2) Tracking the number of outcome measures showing no improvement or positive evolution; and (3) Recording the instances of exercise performance with excessive workload.
Time frame: During each remote session, there will be a total of 22 weeks with 42 sessions between the 2nd and 24th postoperative week.
Acceptability: Satisfaction
Qualitative data: Patients will be asked to respond to some open-ended questions about their experience in remote sessions. These questions will be about: (1) attendance; (2) positive and negative consequences the intervention; and (3) other parameters about the intervention satisfaction it self. There will be a predetermined questionnaire on a Likert Scale, from 0=very dissatisfied, to 4=very satisfied regarding general satisfaction.
Time frame: During each orthopaedic consultation, there will be a total of 7 consultations on the 2nd, 4th, 8th, 12th, 16th, 20th, and 24th postoperative weeks, spanning a total of 22 weeks.
Acceptability: Motivation
Qualitative data: Participants are asked an open-ended question about their motivation to participate in the intervention using remote sessions.
Time frame: During each orthopaedic consultation, there will be a total of 7 consultations on the 2nd, 4th, 8th, 12th, 16th, 20th, and 24th postoperative weeks, spanning a total of 22 weeks.
No study locations are listed for this record.
This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Évora