Anterior Cruciate Ligament InjurySHOPSNCT03047187
The Functional Status of Anterior Cruciate Ligament Reconstruction (ACLR) Patients at Discharge From Rehabilitation
An observational study of Anterior Cruciate Ligament Injury, run by University of Salford.
Trial summary
Objectives: 1. To examine the ability of ACLR patients at discharge from rehabilitation to perform a single-hop for distance. 2. To examine isometric muscle strength of ACLR patients at discharge from rehabilitation. 3. To examine ACLR patients' self-reported knee function at discharge from rehabilitation 4. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Injury
- What is being tested?
- ACLR
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2017to 1 Apr 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited via orthopaedic consultants patient with unilateral ACL injury and had an ACL reconstruction. The principal investigator will organise to see the individual during their regular hospital appointment at the rehabilitation class to determine eligibility, then they will be briefed on the study and have all of the equipment and procedures explained to them. Any questions will be answered in full.
Who may be able to join
- In order to be eligible for the study they must meet the following:
- Aged between 18 to 40 years old.
- Adult with unilateral ACL injury and had an ACL reconstruction.
- Subjects with no lower limb injury, pelvic or spinal pathology that limits the ability to hop comfortably.
- They are confident they will be able to hop without an adverse reaction. This will be determined by the referring clinicians and approved the individual to hop.
Who cannot join
- Individuals who have any of the following will be excluded from the study:
- 1- Unable to give informed consent or comply with the study procedures. 2. Subjects with cardiovascular, pulmonary or neurological conditions that limited physical activity.
- 3. Subjects with any lower limb, pelvic or spinal pathology that limits the ability to hop comfortably.
- 4. Have not performed any hop landings during rehabilitation or have any apprehension about doing so
Trial locations and contacts
No sites are listed yet.
About this study
Official title: What is the Functional Status of Anterior Cruciate Ligament Reconstruction (ACLR) Patients at Discharge From Rehabilitation
Objectives:
- To examine the ability of ACLR patients at discharge from rehabilitation to perform a single-hop for distance.
- To examine isometric muscle strength of ACLR patients at discharge from rehabilitation.
- To examine ACLR patients' self-reported knee function at discharge from rehabilitation
- To assess the psychological factors for ACLR patients at discharge from rehabilitation.
- To correlate single-hop for distance with self-reported knee function, strength and psychological factors for ACLR patients at discharge from rehabilitation to discover whether any of these factors can predict the others.
Read the detailed description
Aims:
- To investigate subjective measures, objective measures, functional performance and psychological factors for ACLR patients at discharge from rehabilitation.
Hypothesis:
1-a There will be no differences between ACLR patients at discharge from rehabilitation, and return to sport criteria leg symmetry index (LSI ≥ 85%), in functional performance for single-hop for distance tests
1-b There will be no differences between ACLR patients at discharge from rehabilitation, and return to sport criteria leg symmetry index (LSI ≥ 85%), in objective measures of quadriceps and hamstring isometric muscle strength tests.
1-c There will be no differences between ACLR patients at discharge from rehabilitation, and return to sport criteria (LSI ≥ 85%) in subjective measures of self-reported knee function (KOOS) and (IKDC)
1-d There will be no differences in psychological factors for the anterior cruciate ligament return to sport after injury scale (ACL-RSI) between ACLR patients at discharge from rehabilitation and the cut-off score for return to sport (score ˃ 63).
1-e There will be no differences in the psychological factors for the Tampa scale of kinesiophobia between ACLR patients at discharge from rehabilitation and the cut-off score of fear of movement (score ≤ 37).
- To investigate the relationship between self-reported knee function, isometric muscles strength, single-hop test and psychological factors post ACL reconstruction.
Hypothesis:
2-a There will be a correlation between self-reported knee function and isometric muscles strength in ACLR patients at discharge from rehabilitation.
2-b There will be a correlation between self-reported knee function and single-hop test in ACLR patients at discharge from rehabilitation.
2-c There will be a correlation between self-reported knee function and psychological factors in ACLR patients at discharge from rehabilitation.
2-d There will be a correlation between isometric muscles strength and single-hop test in ACLR patients at discharge from rehabilitation.
2-e There will be a correlation between isometric muscles strength and psychological factors in ACLR patients at discharge from rehabilitation.
2-f There will be a correlation between single-hop test and psychological factors in ACLR patients at discharge from rehabilitation.
Study Procedure After the participants confirm that they are interested in the study, they will be seen again at the rehabilitation class during their regular hospital appointment. During the participants' last visit to the rehabilitation department, they will be briefed again about the study, and if they agree to partake, they will be asked to sign the consent form.
Self-reported knee function The participants will be asked to complete the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire on symptoms, stiffness, pain, function daily living, function sport sand recreational activities and quality of life, and The International Knee Documentation Committee subjective knee form (IKDC) questionnaire, which assesses symptoms, function, and sports activity.
Psychological factors The participants will be asked to complete The Tampa Scale for Kinesiophobia (fear of movement) (TSK) which is a questionnaire that assesses pain related fear of movement followed by the Anterior Cruciate ligament Return to Sport after Injury (ACL-RSI) scales, which is a questionnaire that measures athletes' emotions, confidence in performance, and risk appraisal concerning to returning to sport following an ACL injury. A demographics form (age, height and weight) will also be completed.
Isometric muscle strength To gather isometric muscle strength data on each participant, data on isometric muscle strength for both legs will be obtained using two different tests for knee extensors and knee flexors muscles, using a hand-held dynamometer (HHD). The participants will be asked to wear sports clothing. The strength of both lower limbs of the participants will be assessed using the HHD, with peak force measured throughout five seconds of muscle contraction. Quadriceps muscles will be measured by first requesting the participants sit on the edge of the treatment bed with their knees 90 degrees flexion and both feet off the ground. The participants will then be asked to apply maximum force in extending the knee joint against the HHD device, which will be fixed using a belt and placed in front of the leg proximal to the ankle joint. They will be asked to do so for five seconds, and to repeat three times with 30 seconds of rest in between. The maximum peak force will be recorded throughout the three trials. To measure hamstring muscles, participants will be instructed to sit on the edge of the treatment bed with 90 degrees' flexion in the knee with both feet off the ground. Then, participants will be instructed to apply maximum force to flex knee joint against the immovable HHD device that will be fixed with a belt and placed at the back of the leg proximal to the ankle joint. They will be asked to so for five seconds, and this will be repeated three times with 30 seconds of rest in between. Maximum peak force will be recorded throughout the three trials.
Functional tasks Participants will be requested to perform a single-leg hop for distance, and this will be assessed using a standard metric tape measure. A 3m strip of tape will be placed on the floor, with the start line labelled using a 0.3m strip of tape placed perpendicular to the 3m strip of tape. The participants will be performed three practice trials for the hop test. After finishing the practice trials, four test trials will be asked to perform a single leg hop for distance as described by (Bolgla and Keskula, 1997). Attempts will be classified as successful provided the participant hops and lands with full stability on one leg for three seconds. The participants will be required to achieve four maximum hop attempts with complete stabilisation after landing for three seconds. Attempts will be deemed unsuccessful if the participant hops and touches the ground with their other leg during landing, or if they fail to hop within the limited marked distance; any failed hops will be counted and noted, but not processed. The participant's leg length will be measured while they are lying in a supine position before the first test using a standard tape measure to measure from the anterior superior iliac spine (ASIS) to the distal tip of the medial malleolus. Leg length will be used during data analysis to normalise excursion distances.
The participants will begin with their toe on the starting line, standing on one leg, before hopping as far as they can horizontally and landing on the same leg, and the distance hopped will be recorded. The hop data will be normalised to limb length by dividing the distance covered by the participant's leg length and then multiplying by 100, resulting in a percentage value. After completing the test, the participants will be asked to repeat the procedure with the other leg.
- Conditions
- Anterior Cruciate Ligament Injury
- Being tested
- ACLR
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACLRDiagnostic test
- quadriceps and hamstring isometric muscles test
- single hop for distance
- IKDC, KOOS, Tampa and ACL-RSI Questionnaires
| Study group | Role | What they receive |
|---|---|---|
| ACLR patients | anterior cruciate ligament reconstruction patients Receives: Diagnostic Test: ACLR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hop test: by measuring the distance of single-hop for distance.
assessment of single hop for distance for ACLR patients at discharge from rehabilitation.
Measured: 12 months
Secondary outcomes (5)
Muscles strength: by measuring the peak force by using hand-held dynamometer
assessment of isometric quadriceps and hamstring muscles strength for ACLR patients at discharge from rehabilitation by using hand-held dynamometer.
Measured: 12 months
Knee functions: by using (KOOS)
assessment of knee functions for ACLR patients at discharge from rehabilitation by using: The Knee injury and Osteoarthritis Outcome Score (KOOS).
Measured: 12 months
Knee functions: by using (IKDC)
assessment of knee functions for ACLR patients at discharge from rehabilitation by using: The International Knee Documentation Committee (IKCD).
Measured: 12 months
Fear of re-injury by using (TSK-17).
Assessment of fear of re-injury for ACLR patients at discharge from rehabilitation by using:
TAMPA scale of kinesiophobia (TSK-17)
Measured: 12 months
Readiness to return to sport after injury by using (ACL-RSI) scale.
Assessment of readiness to return to play after injury for ACLR patients at discharge from rehabilitation by using:
Anterior Cruciate Ligament Return to Sports after Injury (ACL-RSI) scale.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start1 Jun 2017 (estimated)
- Primary completion1 Apr 2018 (estimated)
- Study completion1 Apr 2018 (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 InjuryStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salford
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Husam Abdullah Almalki, University of Salford
- Investigators
- Lee Herrington, PhD, Study chair, University of Salford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047187
- Sponsor's protocol ID
- 001
- Acronym
- SHOPS
- Status last verified
- May 2017
- First submitted
- 31 Jan 2017
- Last updated
- 2 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Functional Status of Anterior Cruciate Ligament Reconstruction (ACLR) Patients at Discharge From Rehabilitation
- ClinicalTrials.gov ID
- NCT03047187
- Acronym / sponsor ID
- SHOPS / 001
- Conditions
- Anterior Cruciate Ligament Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of SalfordUniversity, hospital or other
- Study start
- 1 Jun 2017 (estimated)
- Primary completion
- 1 Apr 2018 (estimated)
- Study completion
- 1 Apr 2018 (estimated)
- First posted
- 8 Feb 2017 (estimated)
- 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.
Objectives:
- To examine the ability of ACLR patients at discharge from rehabilitation to perform a single-hop for distance.
- To examine isometric muscle strength of ACLR patients at discharge from rehabilitation.
- To examine ACLR patients' self-reported knee function at discharge from rehabilitation
- To assess the psychological factors for ACLR patients at discharge from rehabilitation.
- To correlate single-hop for distance with self-reported knee function, strength and psychological factors for ACLR patients at discharge from rehabilitation to discover whether any of these factors can predict the others.
Detailed description
Aims:
- To investigate subjective measures, objective measures, functional performance and psychological factors for ACLR patients at discharge from rehabilitation.
Hypothesis:
1-a There will be no differences between ACLR patients at discharge from rehabilitation, and return to sport criteria leg symmetry index (LSI ≥ 85%), in functional performance for single-hop for distance tests
1-b There will be no differences between ACLR patients at discharge from rehabilitation, and return to sport criteria leg symmetry index (LSI ≥ 85%), in objective measures of quadriceps and hamstring isometric muscle strength tests.
1-c There will be no differences between ACLR patients at discharge from rehabilitation, and return to sport criteria (LSI ≥ 85%) in subjective measures of self-reported knee function (KOOS) and (IKDC)
1-d There will be no differences in psychological factors for the anterior cruciate ligament return to sport after injury scale (ACL-RSI) between ACLR patients at discharge from rehabilitation and the cut-off score for return to sport (score ˃ 63).
1-e There will be no differences in the psychological factors for the Tampa scale of kinesiophobia between ACLR patients at discharge from rehabilitation and the cut-off score of fear of movement (score ≤ 37).
- To investigate the relationship between self-reported knee function, isometric muscles strength, single-hop test and psychological factors post ACL reconstruction.
Hypothesis:
2-a There will be a correlation between self-reported knee function and isometric muscles strength in ACLR patients at discharge from rehabilitation.
2-b There will be a correlation between self-reported knee function and single-hop test in ACLR patients at discharge from rehabilitation.
2-c There will be a correlation between self-reported knee function and psychological factors in ACLR patients at discharge from rehabilitation.
2-d There will be a correlation between isometric muscles strength and single-hop test in ACLR patients at discharge from rehabilitation.
2-e There will be a correlation between isometric muscles strength and psychological factors in ACLR patients at discharge from rehabilitation.
2-f There will be a correlation between single-hop test and psychological factors in ACLR patients at discharge from rehabilitation.
Study Procedure After the participants confirm that they are interested in the study, they will be seen again at the rehabilitation class during their regular hospital appointment. During the participants' last visit to the rehabilitation department, they will be briefed again about the study, and if they agree to partake, they will be asked to sign the consent form.
Self-reported knee function The participants will be asked to complete the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire on symptoms, stiffness, pain, function daily living, function sport sand recreational activities and quality of life, and The International Knee Documentation Committee subjective knee form (IKDC) questionnaire, which assesses symptoms, function, and sports activity.
Psychological factors The participants will be asked to complete The Tampa Scale for Kinesiophobia (fear of movement) (TSK) which is a questionnaire that assesses pain related fear of movement followed by the Anterior Cruciate ligament Return to Sport after Injury (ACL-RSI) scales, which is a questionnaire that measures athletes' emotions, confidence in performance, and risk appraisal concerning to returning to sport following an ACL injury. A demographics form (age, height and weight) will also be completed.
Isometric muscle strength To gather isometric muscle strength data on each participant, data on isometric muscle strength for both legs will be obtained using two different tests for knee extensors and knee flexors muscles, using a hand-held dynamometer (HHD). The participants will be asked to wear sports clothing. The strength of both lower limbs of the participants will be assessed using the HHD, with peak force measured throughout five seconds of muscle contraction. Quadriceps muscles will be measured by first requesting the participants sit on the edge of the treatment bed with their knees 90 degrees flexion and both feet off the ground. The participants will then be asked to apply maximum force in extending the knee joint against the HHD device, which will be fixed using a belt and placed in front of the leg proximal to the ankle joint. They will be asked to do so for five seconds, and to repeat three times with 30 seconds of rest in between. The maximum peak force will be recorded throughout the three trials. To measure hamstring muscles, participants will be instructed to sit on the edge of the treatment bed with 90 degrees' flexion in the knee with both feet off the ground. Then, participants will be instructed to apply maximum force to flex knee joint against the immovable HHD device that will be fixed with a belt and placed at the back of the leg proximal to the ankle joint. They will be asked to so for five seconds, and this will be repeated three times with 30 seconds of rest in between. Maximum peak force will be recorded throughout the three trials.
Functional tasks Participants will be requested to perform a single-leg hop for distance, and this will be assessed using a standard metric tape measure. A 3m strip of tape will be placed on the floor, with the start line labelled using a 0.3m strip of tape placed perpendicular to the 3m strip of tape. The participants will be performed three practice trials for the hop test. After finishing the practice trials, four test trials will be asked to perform a single leg hop for distance as described by (Bolgla and Keskula, 1997). Attempts will be classified as successful provided the participant hops and lands with full stability on one leg for three seconds. The participants will be required to achieve four maximum hop attempts with complete stabilisation after landing for three seconds. Attempts will be deemed unsuccessful if the participant hops and touches the ground with their other leg during landing, or if they fail to hop within the limited marked distance; any failed hops will be counted and noted, but not processed. The participant's leg length will be measured while they are lying in a supine position before the first test using a standard tape measure to measure from the anterior superior iliac spine (ASIS) to the distal tip of the medial malleolus. Leg length will be used during data analysis to normalise excursion distances.
The participants will begin with their toe on the starting line, standing on one leg, before hopping as far as they can horizontally and landing on the same leg, and the distance hopped will be recorded. The hop data will be normalised to limb length by dividing the distance covered by the participant's leg length and then multiplying by 100, resulting in a percentage value. After completing the test, the participants will be asked to repeat the procedure with the other leg.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACLR patients | – | Diagnostic Test: ACLRanterior cruciate ligament reconstruction patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited via orthopaedic consultants patient with unilateral ACL injury and had an ACL reconstruction. The principal investigator will organise to see the individual during their regular hospital appointment at the rehabilitation class to determine eligibility, then they will be briefed on the study and have all of the equipment and procedures explained to them. Any questions will be answered in full.
Key inclusion criteria (5 listed)
- Aged between 18 to 40 years old.
- Adult with unilateral ACL injury and had an ACL reconstruction.
- Subjects with no lower limb injury, pelvic or spinal pathology that limits the ability to hop comfortably.
- They are confident they will be able to hop without an adverse reaction. This will be determined by the referring clinicians and approved the individual to hop.
Key exclusion criteria (4 listed)
- 1- Unable to give informed consent or comply with the study procedures. 2. Subjects with cardiovascular, pulmonary or neurological conditions that limited physical activity.
- 3. Subjects with any lower limb, pelvic or spinal pathology that limits the ability to hop comfortably.
- 4. Have not performed any hop landings during rehabilitation or have any apprehension about doing so
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 |
|---|---|---|
| ACLR* quadriceps and hamstring isometric muscles test * single hop for distance * IKDC, KOOS, Tampa and ACL-RSI Questionnaires | Diagnostic test | ACLR patients |
Primary outcome
Hop test: by measuring the distance of single-hop for distance.
Time frame: 12 months
assessment of single hop for distance for ACLR patients at discharge from rehabilitation.
5 secondary outcomes
Muscles strength: by measuring the peak force by using hand-held dynamometer
Time frame: 12 months
Knee functions: by using (KOOS)
Time frame: 12 months
Knee functions: by using (IKDC)
Time frame: 12 months
Fear of re-injury by using (TSK-17).
Time frame: 12 months
Readiness to return to sport after injury by using (ACL-RSI) scale.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
- Individual participant dataSharing planned: No
Related trials for Anterior Cruciate Ligament Injury
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
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.
Lee Herrington, PhD study chair
University of Salford
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Injury, run by University of Salford.
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 4 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 2 May 2017. 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 Husam A Almalki, MSc (+447429277737, H.A.S.Almalki@edu.salford.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hop test: by measuring the distance of single-hop for distance. (time frame: 12 months). 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 2 May 2017.