Anterior Cruciate Ligament ReconstructionNCT06152380
Knee Care @Home Programme Feasibility Trial
An observational study of Anterior Cruciate Ligament Reconstruction, run by University of Évora.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- What is being tested?
- Knee Care @Home Programme
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 28 Feb 2024
- Phase
- Observational
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients who have undergone anterior cruciate ligament reconstruction at Hospital da Misericórdia de Évora.
Who may be able to join
- Undergone primary ACLR regardless of surgical method and choice of autograft.
- Have a healthy contralateral (opposite) knee.
- The time between ACL injury and ACLR should not exceed 12 months.
Who cannot join
- Declined to participate.
- Concomitant osteochondral injuries.
- Undergone multiple reconstructions of the lateral collateral ligament or posterior cruciate ligament.
- Significant lower limb injuries within the 12 months before the ACL injury.
- Medical conditions that may affect recovery.
- Using medication for mental disorders.
- Severe impairments in communication or balance.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Implementation of the Knee Care @Home Programme for Patients Recovering Anterior Cruciate Ligament Reconstruction: Protocol for a Randomised Feasibility Trial
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.
Read the detailed description
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).
- Being tested
- Knee Care @Home Programme
- Keywords
- Feasibility, Acceptability, Barriers, Facilitators, Anterior Cruciate Ligament Reconstruction, Internet-based Intervention, Exercise Therapy, Patient Satisfaction, Patient Engagement
- Medical subject headings
- Patient Satisfaction, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee Care @Home ProgrammeOther
Also called Synchronous internet-based remote sessions, Therapeutic Exercises
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.
| Study group | Role | What they receive |
|---|---|---|
| Clinic-based Rehabilitation | Individualised clinic-based face-to-face sessions with a physiotherapist in public or private rehabilitation facility | |
| Knee Care @Home | 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. Receives: Other: Knee Care @Home Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 36 weeks postoperative
Data Collection: Missing data
Quantitative data includes the number of missing items.
Measured: 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.
Measured: 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).
Measured: 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.
- Open-ended questions will be asked to participants and coaches about reasons for absence from remote sessions (qualitative data).
- 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).
- Data will be collected on attendance, cancellations, lateness, logins, and completed remote sessions (quantitative data). Patient log sheets will be evaluated for qualitative data.
- Data will be collected on completed remote sessions, session parameters, exercises, and costs (quantitative data).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion30 Jan 2024 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Évora
- Sponsor type
- University, hospital or other
- Collaborators
- Comprehensive Health Research Center, Fundação para a Ciência e a Tecnologia, Hospital da Misericórdia de Évora
- Responsible party
- Principal investigator, Joao Paulo Brites de Sousa, University of Évora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152380
- Sponsor's protocol ID
- KC@H Feasibility
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 30 Nov 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 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the Knee Care @Home Programme for Patients Recovering Anterior Cruciate Ligament Reconstruction: Protocol for a Randomised Feasibility Trial
- ClinicalTrials.gov ID
- NCT06152380
- Acronym / sponsor ID
- KC@H Feasibility
- Keywords
- Feasibility, Acceptability, Barriers, Facilitators, Anterior Cruciate Ligament Reconstruction, Internet-based Intervention, Exercise Therapy, Patient Satisfaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University of ÉvoraUniversity, hospital or other
- Collaborators
- Comprehensive Health Research Center, Fundação para a Ciência e a Tecnologia, Hospital da Misericórdia de Évora
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 30 Nov 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.
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.
Detailed description
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinic-based Rehabilitation | – | –Individualised clinic-based face-to-face sessions with a physiotherapist in public or private rehabilitation facility |
| Knee Care @Home | – | Other: Knee Care @Home ProgrammeIndividualised 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who have undergone anterior cruciate ligament reconstruction at Hospital da Misericórdia de Évora.
Key inclusion criteria (3 listed)
- Undergone primary ACLR regardless of surgical method and choice of autograft.
- Have a healthy contralateral (opposite) knee.
- The time between ACL injury and ACLR should not exceed 12 months.
Key exclusion criteria (7 listed)
- Declined to participate.
- Concomitant osteochondral injuries.
- Undergone multiple reconstructions of the lateral collateral ligament or posterior cruciate ligament.
- Significant lower limb injuries within the 12 months before the ACL injury.
- Medical conditions that may affect recovery.
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 |
|---|---|---|
| Knee Care @Home ProgrammeAlso: Synchronous internet-based remote sessions, Therapeutic ExercisesOver 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. | Other | Knee Care @Home |
Primary outcome
Enrolment: Screening
Time frame: Preoperative consultation
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.
Enrolment: Informed Consent
Time frame: Preoperative consultation
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.
Enrolment: Eligibility
Time frame: First consultation after surgery (second week)
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.
Enrolment: Allocation
Time frame: First consultation after surgery (second week)
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.
Data Collection: Response rates
Time frame: Up to 36 weeks postoperative
Quantitative data includes the total number of outcome evaluation tools, the minutes spent using evaluation tools, and the number of unusable outcome measures.
Data Collection: Missing data
Time frame: Up to 36 weeks postoperative
Quantitative data includes the number of missing items.
Data Collection: Implementation and Technical issues
Time frame: During each remote session, there will be a total of 22 weeks with 42 sessions between the 2nd and 24th postoperative week.
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.
Intervention Fidelity: Adherence to the trial
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.
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).
Intervention Fidelity: Adherence rate at 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.
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).
Intervention Fidelity: Adherence rate at 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.
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.
Intervention Fidelity: Quality of delivery
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.
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).
Intervention Fidelity: Participant Responsiveness
Time frame: During each remote session, there will be a total of 22 weeks with 42 sessions between the 2nd and 24th postoperative week.
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).
Intervention Fidelity: Safety (adverse events)
Time frame: During each remote session, there will be a total of 22 weeks with 42 sessions between the 2nd and 24th postoperative week.
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.
Acceptability: 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.
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.
Acceptability: Motivation
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.
Qualitative data: Participants are asked an open-ended question about their motivation to participate in the intervention using remote sessions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Reconstruction, run by University of Évora.
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 3 inclusion and 7 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 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Daniela Carmelo Pina, MSc (965732769, dcpina@outlook.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrolment: Screening (time frame: Preoperative consultation). The study lists 15 primary outcomes in all. 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 30 Nov 2023.