Anterior Cruciate Ligament ReconstructionKC@HNCT05828355
The Knee Care @Home Programme Following Anterior Ligament Reconstruction
A study testing Knee Care@Home Programme in people with Anterior Cruciate Ligament Reconstruction, run by University of Évora at 1 site in Portugal.
Trial summary
Background: Patients who are unable to fully comply with conventional clinic-based rehabilitation sessions after anterior cruciate ligament reconstruction may find additional internet-based sessions beneficial. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Dec 2023to 30 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
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 health disorders.
- Severe impairments in communication or balance.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Hospital da Misericórdia de Évora
Evora, 7000-865
Gabriel Xavier, MD, 964551665, gfxavier@hotmail.com
Gabriel Xavier, MD
About this study
Official title: Effectiveness of the KC@H Programme Compared With Clinic-based Rehabilitation in Patients Recovering From Anterior Cruciate Ligament Reconstruction: Study Protocol for a Single-centre, Randomised Controlled Superiority Trial.
Background: Patients who are unable to fully comply with conventional clinic-based rehabilitation sessions after anterior cruciate ligament reconstruction may find additional internet-based sessions beneficial. These remote sessions include therapeutic exercises that can be done at home, potentially extending the reach of rehabilitation services to underserved areas, prolonging the duration of care, and providing improved supervision.
Objective: To determine if the Knee Care at Home programme is more effective than conventional clinic-based rehabilitation alone in improving patient-reported, clinician-reported, and physical functional performance outcome measures after anterior cruciate ligament reconstruction. Additionally, the trial pursues to assess the significance of changes in outcome measures for clinical practice.
Read more
Methods/design: This protocol outlines a randomised controlled trial for postoperative recovery following anterior cruciate ligament reconstruction. Adult participants of both sexes who meet specific criteria will be randomly assigned to either the Clinic-based Rehabilitation group or the Knee Care at Home group. Only the latter group will receive internet-based sessions of therapeutic exercises at home, in addition to clinic-based rehabilitation sessions. A follow-up evaluation will be conducted for both groups 12 weeks after the intervention ends.
Expected Results: The Knee Care at Home programme is superior to conventional clinic-based rehabilitation alone for patients recovering from anterior cruciate ligament reconstruction across multiple outcome measures. Also, the programme has the potential to promote superior recovery and extend the reach and duration of care.
- Being tested
- Knee Care@Home Programme
- Keywords
- Anterior Cruciate Ligament Reconstruction, Patient-reported Outcomes Measures, Clinician-reported Outcomes Measures, Functional Performance, Clinical Relevance, Internet-based Intervention, Exercise Therapy
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 Exercise
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 | No intervention | Individualised clinic-based face-to-face sessions with a physiotherapist in public or private rehabilitation facility |
| Knee Care@Home | Experimental | 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.
Standing height
Patients are measured for standing height in centimetres using a stadiometer placed against the wall. They are instructed to stand with their backs against the wall, heels together, head in a natural position, legs straight, arms at their sides, and shoulders relaxed. They should not wear shoes or heavy clothing that could affect their height measurement. The measurement arm is lowered to rest gently on the patient's head, and the measurement is rounded off to the nearest decimal.
Measured: Preoperative consultation
Weight
Patients are assessed for weight (body mass in kilograms) using a traditional weighing scale. The scale is placed on a flat and stable surface, and patients are advised not to wear shoes or heavy clothing that could affect their weight measurement. They are instructed to stand still in the centre of the scale, with their feet evenly positioned and their weight evenly distributed. The weight measurement is then recorded and rounded off to the nearest decimal.
Measured: up to 36 weeks postoperative
Knee pain during the last 24 hours
Visual Analogue Scale (VAS). Patients provide feedback on the intensity of their knee pain by marking a point on a 100mm straight horizontal line. The beginning of the line represents "no pain" while the end represents the "worst possible pain". A ruler is used to measure the distance (in millimetres) from 0 to the patient's marking. Additionally, a numerical value and Wong-Baker faces scale will be presented to the patient for reference.
Measured: up to 36 weeks postoperative
Knee pain during the last week
Knee Injury and Osteoarthritis Outcome Score (KOOS) for pain. Patients provide feedback on the severity of their knee pain using a standard 5-point Likert scale. Each response option is assigned a numerical value (0 for none, 1 for mild, 2 for moderate, 3 for severe, and 4 for extreme). A score of 0 indicates no pain, while a score of 32 (based on 8 questions) indicates extreme pain.
Measured: up to 36 weeks postoperative
Knee symptoms and stiffness during the last week
Knee injury and Osteoarthritis Outcome Score (KOOS) for symptoms and stiffness. Patients are asked to rate their knee symptoms and stiffness using a standard 5-point Likert scale, with each response option assigned a numerical value (0, 1, 2, 3, 4). A score of 0 indicates total absence of symptoms, while a score of 20 (based on 5 questions) indicates constant symptoms. For knee stiffness, a score of 0 indicates total absence, while a score of 8 (based on 2 questions) indicates extreme stiffness.
Measured: up to 36 weeks postoperative
Knee-related physical function during the last week
Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS). Patients use a standard 5-point Likert scale to provide feedback on their knee-related physical function. Each response option is assigned a numerical value (0 for none, 1 for mild, 2 for moderate, 3 for severe, and 4 for extreme). A score of 0 indicates no difficulties, while a score of 28 (based on 7 questions) indicates extreme difficulties.
Measured: up to 36 weeks postoperative
Knee function in daily living, sports, and recreational activities during the last week
Knee injury and Osteoarthritis Outcome Score (KOOS) for function in daily living, sports, and recreational activities: Patients are asked to rate their knee function in daily living, sports, and recreational activities using a standard 5-point Likert scale. Each response option is given a numerical value (0 for none, 1 for mild, 2 for moderate, 3 for severe, and 4 for extreme). For knee function in daily living, a score of 0 indicates no difficulties, while a score of 68 (based on 17 questions) indicates extreme difficulties. Similarly, for knee function in sports and recreational activities, a score of 0 indicates no difficulties, while a score of 20 (based on 5 questions) indicates extreme difficulties.
Measured: up to 36 weeks postoperative
Knee-related quality of life
Knee injury and Osteoarthritis Outcome Score (KOOS) for quality of life. Patients using a standard 5-point Likert scale to provide feedback on their knee-related quality of life. Each response option is given a numerical value (0, 1, 2, 3, 4) and a raw score is determined based on their responses. A score of 0 indicates no impact, while a score of 4 (based on 4 questions) indicates extreme impact on the quality of life.
Measured: up to 36 weeks postoperative
Knee joint effusion
Patellar Tap/Ballottement Test. Patients are evaluated for knee effusion while lying supine on an examination table. The assessor applies downward strokes from the thigh to the leg with the non-dominant hand and then grasps the upper portion of the knee just above the patella. Using two fingers of the dominant hand they press the patella against the femur in a posterior direction. A positive test result for knee effusion is indicated by increased patellar waving or a spongy joint sensation. The test is then repeated on the opposite knee for comparison.
Measured: up to 36 weeks postoperative
Passive knee flexion and extension range of motion
Hand-held Goniometry (HHG): Passive knee extension and flexion range of motion are measured using a long-arm goniometer. The goniometer axis is placed at the lateral epicondyle of the femur. The proximal arm is placed alongside the lateral midline of the femur, using the greater trochanter as a reference, while the distal arm is placed alongside the lateral midline of the fibula, using the lateral malleolus and fibular head as references. Passive knee flexion: the patient lies in a supine position on the table with the lower limbs in an anatomical position. The assessor flexes the knee by sliding the patient's foot along the table towards the pelvis and then taking the passive range of motion measurement. Passive knee extension: the patient lies in a supine position on the table with a towel under the ankle with the knee extended as far as possible. The assessor provides added pressure to the knee in the direction of extension and then takes the passive range of motion measurement.
Measured: up to 36 weeks postoperative
Knee extensor and flexor muscle length
Hand-held Goniometry (HHG): The length of the knee flexors and extensors muscles is measured with a long-arm goniometer. The goniometer axis placed at the lateral epicondyle of the femur. For the flexor muscle length, the patient lies in a prone position with both hips of the lower extremity extended on the table, and the knee to be tested moves to maximal achieved flexion, and the measurement of knee flexion is taken (test side). For the extensors length, the patient lies in a supine position with the hip of the lower extremity to be measured in 90 degrees of flexion on the table. While the assessor helps to maintain the hip position, the patient executes a knee extension, and the measurement of knee flexion is taken (test side).
Measured: up to 36 weeks postoperative
Knee extensor and flexor isometric muscle strength
Hand-held Dynamometry (HHD): The microFET®2 is used to measure the isometric strength of the hamstrings and quadriceps in patients. This measurement is taken on both knees to allow for comparison. The patient is seated with their hips and knees flexed at a 90-degree angle on an examination table. The assessor stabilizes the patient's leg using the leg of the examination table as support for the hand-held dynamometer. The patient is then instructed to apply maximum force against the device. First, the patient is asked to try to extend the knee, and then they are asked to flex the knee. Three repetitions are performed for both extension and flexion.
Measured: up to 36 weeks postoperative
Knee pain catatrophising
Pain Catastrophizing Scale (PCS): Patients are asked to provide feedback on their thoughts, feelings, or perceptions related to pain using a standard 5-point Likert scale. Each response option is assigned a numerical value (0 for "not at all", 1 for "a slight degree", 2 for "moderate degree", 3 for "great degree", to 4 for "all the time"). A score of 0 indicates a total absence of catastrophic thinking, while a score of 52 (based on 13 questions) indicates a persistent tendency towards catastrophising thoughts about pain.
Measured: up to 36 weeks postoperative
Anxiety, depression, and stress during last week
Depression Anxiety Stress Scales (DASS-21) short-form: Patients use a standard 4-point Likert scale. Each response option is assigned a numerical value (0 for "did not apply to me at all", 1 for "applied to me to some degree, or some of the time", 2 for "applied to me to a considerable degree or a good part of time", and 3 for "applied to me very much or most of the time"). Cut-off scores determine the severity. For depression, based on 7 items, scores of 0 to 9 are considered normal, 10 to 13 are mild, 14 to 20 are moderate, 21 to 27 are severe, and 28 or higher are extremely severe. For anxiety, based on 7 items, scores of 0 to 7 are normal, 8 to 9 are mild, 10 to 14 are moderate, 15 to 19 are severe, and 20 or higher are extremely severe. For stress, based on 7 items, scores of 0 to 14 are normal, 15 to 18 are mild, 19 to 25 are moderate, 26 to 33 are severe, and 34 or higher are extremely severe.
Measured: up to 36 weeks postoperative
Hop distance on a single leg
Patients are instructed to stand on the leg being tested, hop, and then land on the same limb, jumping as far as possible. The distance hopped is measured at the level of the great toe and recorded to the nearest centimetre using a standard measuring tape that is fixed to the floor. Both lower limbs are evaluated for comparison.
Measured: up to 36 weeks postoperative
Ability to ascend and descend a flight of stairs (12 steps)
Stair Climbing (SC) test: Patients will be timed as they ascend and descend a flight of 12 stairs as quickly as possible. The number of steps they perform in 30-second intervals will also be counted.
Measured: up to 36 weeks postoperative
Secondary outcomes (3)
Symptom State
Patient Acceptable Symptomatic State (PASS): Patients provide their perspectives on the final PROM scores, which indicate their satisfaction with symptoms. For each PROM score, patients are asked a question with the answer option "yes" or "no".
Measured: up to 36 weeks postoperative
Clinical Benefit
Substantial Clinical Benefit (SCB): Patients are surveyed to gather their perspective on the change in PROM scores that indicates a significant or optimal improvement. For each change in score, patients are asked a question with answer options displayed on a 7-point Likert scale, ranging from "significant and marked improvement" to "no improvement at all".
Measured: up to 36 weeks postoperative
Clinical Difference
Minimal Clinically Important Difference (MCID): The patients will be asked about their opinion on the minimum change in PROM scores that would show a meaningful improvement in their condition. We will use an anchor-based technique to determine the MCID.
Measured: up to 36 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start1 Dec 2023 (estimated)
- Primary completion30 Jan 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- 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
- Investigators
- João Paulo Sousa, PhD, Principal investigator, Universidade de Évora - Comprehensive Health Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828355
- Sponsor's protocol ID
- KC@H RCT
- Acronym
- KC@H
- Status last verified
- Nov 2023
- First submitted
- 17 Mar 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alegrete J, Batalha N, Fernandes O, Parraca JA, Rodrigues AM, Londral AR, Sousa JP. Effectiveness of the KC@H programme compared with clinic-based rehabilitation in patients recovering from ACL reconstruction: a study protocol for a single-centre, two-arm, single-blinded, randomised controlled superiority trial. BMJ Open Sport Exerc Med. 2024 Feb 21;10(1):e001868. doi: 10.1136/bmjsem-2023-001868. eCollection 2024.
PubMed 38390383
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the KC@H Programme Compared With Clinic-based Rehabilitation in Patients Recovering From Anterior Cruciate Ligament Reconstruction: Study Protocol for a Single-centre, Randomised Controlled Superiority Trial.
- ClinicalTrials.gov ID
- NCT05828355
- Acronym / sponsor ID
- KC@H / KC@H RCT
- Keywords
- Anterior Cruciate Ligament Reconstruction, Patient-reported Outcomes Measures, Clinician-reported Outcomes Measures, Functional Performance, Clinical Relevance, Internet-based Intervention, Exercise Therapy
- Study type
- Interventional
- 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
- 30 Jun 2024 (estimated)
- First posted
- 25 Apr 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.
Background: Patients who are unable to fully comply with conventional clinic-based rehabilitation sessions after anterior cruciate ligament reconstruction may find additional internet-based sessions beneficial. These remote sessions include therapeutic exercises that can be done at home, potentially extending the reach of rehabilitation services to underserved areas, prolonging the duration of care, and providing improved supervision.
Objective: To determine if the Knee Care at Home programme is more effective than conventional clinic-based rehabilitation alone in improving patient-reported, clinician-reported, and physical functional performance outcome measures after anterior cruciate ligament reconstruction. Additionally, the trial pursues to assess the significance of changes in outcome measures for clinical practice.
Methods/design: This protocol outlines a randomised controlled trial for postoperative recovery following anterior cruciate ligament reconstruction. Adult participants of both sexes who meet specific criteria will be randomly assigned to either the Clinic-based Rehabilitation group or the Knee Care at Home group. Only the latter group will receive internet-based sessions of therapeutic exercises at home, in addition to clinic-based rehabilitation sessions. A follow-up evaluation will be conducted for both groups 12 weeks after the intervention ends.
Expected Results: The Knee Care at Home programme is superior to conventional clinic-based rehabilitation alone for patients recovering from anterior cruciate ligament reconstruction across multiple outcome measures. Also, the programme has the potential to promote superior recovery and extend the reach and duration of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinic-based Rehabilitation | No intervention | –Individualised clinic-based face-to-face sessions with a physiotherapist in public or private rehabilitation facility |
| Knee Care@Home | Experimental | 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
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 ExerciseOver 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
Standing height
Time frame: Preoperative consultation
Patients are measured for standing height in centimetres using a stadiometer placed against the wall. They are instructed to stand with their backs against the wall, heels together, head in a natural position, legs straight, arms at their sides, and shoulders relaxed. They should not wear shoes or heavy clothing that could affect their height measurement. The measurement arm is lowered to rest gently on the patient's head, and the measurement is rounded off to the nearest decimal.
Weight
Time frame: up to 36 weeks postoperative
Patients are assessed for weight (body mass in kilograms) using a traditional weighing scale. The scale is placed on a flat and stable surface, and patients are advised not to wear shoes or heavy clothing that could affect their weight measurement. They are instructed to stand still in the centre of the scale, with their feet evenly positioned and their weight evenly distributed. The weight measurement is then recorded and rounded off to the nearest decimal.
Knee pain during the last 24 hours
Time frame: up to 36 weeks postoperative
Visual Analogue Scale (VAS). Patients provide feedback on the intensity of their knee pain by marking a point on a 100mm straight horizontal line. The beginning of the line represents "no pain" while the end represents the "worst possible pain". A ruler is used to measure the distance (in millimetres) from 0 to the patient's marking. Additionally, a numerical value and Wong-Baker faces scale will be presented to the patient for reference.
Knee pain during the last week
Time frame: up to 36 weeks postoperative
Knee Injury and Osteoarthritis Outcome Score (KOOS) for pain. Patients provide feedback on the severity of their knee pain using a standard 5-point Likert scale. Each response option is assigned a numerical value (0 for none, 1 for mild, 2 for moderate, 3 for severe, and 4 for extreme). A score of 0 indicates no pain, while a score of 32 (based on 8 questions) indicates extreme pain.
Knee symptoms and stiffness during the last week
Time frame: up to 36 weeks postoperative
Knee injury and Osteoarthritis Outcome Score (KOOS) for symptoms and stiffness. Patients are asked to rate their knee symptoms and stiffness using a standard 5-point Likert scale, with each response option assigned a numerical value (0, 1, 2, 3, 4). A score of 0 indicates total absence of symptoms, while a score of 20 (based on 5 questions) indicates constant symptoms. For knee stiffness, a score of 0 indicates total absence, while a score of 8 (based on 2 questions) indicates extreme stiffness.
Knee-related physical function during the last week
Time frame: up to 36 weeks postoperative
Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS). Patients use a standard 5-point Likert scale to provide feedback on their knee-related physical function. Each response option is assigned a numerical value (0 for none, 1 for mild, 2 for moderate, 3 for severe, and 4 for extreme). A score of 0 indicates no difficulties, while a score of 28 (based on 7 questions) indicates extreme difficulties.
Knee function in daily living, sports, and recreational activities during the last week
Time frame: up to 36 weeks postoperative
Knee injury and Osteoarthritis Outcome Score (KOOS) for function in daily living, sports, and recreational activities: Patients are asked to rate their knee function in daily living, sports, and recreational activities using a standard 5-point Likert scale. Each response option is given a numerical value (0 for none, 1 for mild, 2 for moderate, 3 for severe, and 4 for extreme). For knee function in daily living, a score of 0 indicates no difficulties, while a score of 68 (based on 17 questions) indicates extreme difficulties. Similarly, for knee function in sports and recreational activities, a score of 0 indicates no difficulties, while a score of 20 (based on 5 questions) indicates extreme difficulties.
Knee-related quality of life
Time frame: up to 36 weeks postoperative
Knee injury and Osteoarthritis Outcome Score (KOOS) for quality of life. Patients using a standard 5-point Likert scale to provide feedback on their knee-related quality of life. Each response option is given a numerical value (0, 1, 2, 3, 4) and a raw score is determined based on their responses. A score of 0 indicates no impact, while a score of 4 (based on 4 questions) indicates extreme impact on the quality of life.
Knee joint effusion
Time frame: up to 36 weeks postoperative
Patellar Tap/Ballottement Test. Patients are evaluated for knee effusion while lying supine on an examination table. The assessor applies downward strokes from the thigh to the leg with the non-dominant hand and then grasps the upper portion of the knee just above the patella. Using two fingers of the dominant hand they press the patella against the femur in a posterior direction. A positive test result for knee effusion is indicated by increased patellar waving or a spongy joint sensation. The test is then repeated on the opposite knee for comparison.
Passive knee flexion and extension range of motion
Time frame: up to 36 weeks postoperative
Hand-held Goniometry (HHG): Passive knee extension and flexion range of motion are measured using a long-arm goniometer. The goniometer axis is placed at the lateral epicondyle of the femur. The proximal arm is placed alongside the lateral midline of the femur, using the greater trochanter as a reference, while the distal arm is placed alongside the lateral midline of the fibula, using the lateral malleolus and fibular head as references. Passive knee flexion: the patient lies in a supine position on the table with the lower limbs in an anatomical position. The assessor flexes the knee by sliding the patient's foot along the table towards the pelvis and then taking the passive range of motion measurement. Passive knee extension: the patient lies in a supine position on the table with a towel under the ankle with the knee extended as far as possible. The assessor provides added pressure to the knee in the direction of extension and then takes the passive range of motion measurement.
Knee extensor and flexor muscle length
Time frame: up to 36 weeks postoperative
Hand-held Goniometry (HHG): The length of the knee flexors and extensors muscles is measured with a long-arm goniometer. The goniometer axis placed at the lateral epicondyle of the femur. For the flexor muscle length, the patient lies in a prone position with both hips of the lower extremity extended on the table, and the knee to be tested moves to maximal achieved flexion, and the measurement of knee flexion is taken (test side). For the extensors length, the patient lies in a supine position with the hip of the lower extremity to be measured in 90 degrees of flexion on the table. While the assessor helps to maintain the hip position, the patient executes a knee extension, and the measurement of knee flexion is taken (test side).
Knee extensor and flexor isometric muscle strength
Time frame: up to 36 weeks postoperative
Hand-held Dynamometry (HHD): The microFET®2 is used to measure the isometric strength of the hamstrings and quadriceps in patients. This measurement is taken on both knees to allow for comparison. The patient is seated with their hips and knees flexed at a 90-degree angle on an examination table. The assessor stabilizes the patient's leg using the leg of the examination table as support for the hand-held dynamometer. The patient is then instructed to apply maximum force against the device. First, the patient is asked to try to extend the knee, and then they are asked to flex the knee. Three repetitions are performed for both extension and flexion.
Knee pain catatrophising
Time frame: up to 36 weeks postoperative
Pain Catastrophizing Scale (PCS): Patients are asked to provide feedback on their thoughts, feelings, or perceptions related to pain using a standard 5-point Likert scale. Each response option is assigned a numerical value (0 for "not at all", 1 for "a slight degree", 2 for "moderate degree", 3 for "great degree", to 4 for "all the time"). A score of 0 indicates a total absence of catastrophic thinking, while a score of 52 (based on 13 questions) indicates a persistent tendency towards catastrophising thoughts about pain.
Anxiety, depression, and stress during last week
Time frame: up to 36 weeks postoperative
Depression Anxiety Stress Scales (DASS-21) short-form: Patients use a standard 4-point Likert scale. Each response option is assigned a numerical value (0 for "did not apply to me at all", 1 for "applied to me to some degree, or some of the time", 2 for "applied to me to a considerable degree or a good part of time", and 3 for "applied to me very much or most of the time"). Cut-off scores determine the severity. For depression, based on 7 items, scores of 0 to 9 are considered normal, 10 to 13 are mild, 14 to 20 are moderate, 21 to 27 are severe, and 28 or higher are extremely severe. For anxiety, based on 7 items, scores of 0 to 7 are normal, 8 to 9 are mild, 10 to 14 are moderate, 15 to 19 are severe, and 20 or higher are extremely severe. For stress, based on 7 items, scores of 0 to 14 are normal, 15 to 18 are mild, 19 to 25 are moderate, 26 to 33 are severe, and 34 or higher are extremely severe.
Hop distance on a single leg
Time frame: up to 36 weeks postoperative
Patients are instructed to stand on the leg being tested, hop, and then land on the same limb, jumping as far as possible. The distance hopped is measured at the level of the great toe and recorded to the nearest centimetre using a standard measuring tape that is fixed to the floor. Both lower limbs are evaluated for comparison.
Ability to ascend and descend a flight of stairs (12 steps)
Time frame: up to 36 weeks postoperative
Stair Climbing (SC) test: Patients will be timed as they ascend and descend a flight of 12 stairs as quickly as possible. The number of steps they perform in 30-second intervals will also be counted.
3 secondary outcomes
Symptom State
Time frame: up to 36 weeks postoperative
Clinical Benefit
Time frame: up to 36 weeks postoperative
Clinical Difference
Time frame: up to 36 weeks postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 38390383Alegrete J, Batalha N, Fernandes O, Parraca JA, Rodrigues AM, Londral AR, Sousa JP. Effectiveness of the KC@H programme compared with clinic-based rehabilitation in patients recovering from ACL reconstruction: a study protocol for a single-centre, two-arm, single-blinded, randomised controlled superiority trial. BMJ Open Sport Exerc Med. 2024 Feb 21;10(1):e001868. doi: 10.1136/bmjsem-2023-001868. eCollection 2024.
- Individual participant dataSharing planned: No
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Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
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.
João Paulo Sousa, PhD principal investigator
Universidade de Évora - Comprehensive Health Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knee Care@Home Programme in people with Anterior Cruciate Ligament Reconstruction, run by University of Évora at 1 site in Portugal.
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 18 Nov 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 Portugal. 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?
Contact João Paulo Sousa, PhD (919662332, jsousa@uevora.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standing height (time frame: Preoperative consultation). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05828355, which also lists 1 linked publication.
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 18 Nov 2023.