Complete Tear, Knee, Anterior Cruciate LigamentPhase 2NCT02930239
Gait Rehabilitation Following an Anterior Cruciate Ligament Reconstruction
A Phase 2 study testing Gait rehabilitating with reduced bodyweight and Standardized rehabilitation following an anterior cruciate ligament reconstruction at Linkoping University Hospital in people with Complete Tear, Knee, Anterior Cruciate Ligament, run by Linkoeping University at 1 site in Sweden.
Trial summary
A randomized control trial where subjects following an anterior cruciate ligament reconstruction will be randomized to either a control group who will receive the normal rehabilitation or an experimental group who will perform a 2-week gait rehabilitation using the anti-gravity treadmill in addition to the normal… Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Complete Tear, Knee, Anterior Cruciate Ligament
- What is being tested?
- Gait rehabilitating with reduced bodyweight and Standardized rehabilitation following an anterior cruciate ligament reconstruction at Linkoping University Hospital
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2016to Feb 2018
- Phase
- Phase 2
- 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 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Anterior cruciate ligament injury occurred a minimum of 3 weeks prior to surgery
Who cannot join
- Previous Anterior cruciate ligament injury
- Other knee injury with restrictions that could interfere with rehabilitation
- Other injury or disease that could interfere with rehabilitation
- Inability to understand the information
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Linkoping University
Linköping, Östergötland County, 58183
Joanna Kvist, Professor, +46 (0) 13 284664, joanna.kvist@liu.se
Joanna Kvist, Professor
About this study
Official title: Early Initiated Gait Rehabilitation Using the Anti-gravity Treadmill Following an Anterior Cruciate Ligament Reconstruction
A randomized control trial where subjects following an anterior cruciate ligament reconstruction will be randomized to either a control group who will receive the normal rehabilitation or an experimental group who will perform a 2-week gait rehabilitation using the anti-gravity treadmill in addition to the normal rehabilitation. The intervention will be added to the existing care received at Linkoping University Hospital 2 weeks post-surgery, while the evaluation will be performed in week 5 and 12 post-surgery using: a 3D-gait analysis (with the Qualisys software), self-reported function questionnaires and a clinical examination.
- Being tested
- Gait rehabilitating with reduced bodyweight, Standardized rehabilitation following an anterior cruciate ligament reconstruction at Linkoping University Hospital
- Keywords
- ACL-reconstruction, Gait rehabilitation, Anti Gravity treadmill, ACL-rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait rehabilitating with reduced bodyweightOther
Patients will perform 8 sessions of gait rehabilitation with reduced bodyweight using the anti gravity treadmill during week 2-5 post-surgery.
Standardized rehabilitation following an anterior cruciate ligament reconstruction at Linkoping University HospitalOther
Exercises for increased movement and circulation performed on a daily basis.
| Study group | Role | What they receive |
|---|---|---|
| Gait rehabilitation | Experimental | Will perform 2 weeks of gait rehabilitation using the anti gravity treadmill. Intervention will start 2 weeks post-surgery. This rehabilitation will be performed simultaneously as the patient receives the standardized rehabilitation at Linkoping University Hospital. Receives: Other: Gait rehabilitating with reduced bodyweight; Other: Standardized rehabilitation following an anterior cruciate ligament reconstruction at Linkoping University Hospital |
| Control group | Active comparator | Will only receive the standardized rehabilitation at Linkoping University Hospital. Receives: Other: Standardized rehabilitation following an anterior cruciate ligament reconstruction at Linkoping University Hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 dimensional gait analysis
A 10 Oqus camera system by Qualisys, Sweden integrated with 3 Kistler forcplates is used. The primary outcome is peak knee flexion during stance phase for injured leg
Measured: 5 weeks post-surgery
Secondary outcomes (3)
Knee Injury and Osteoarthritis Outcome Score
The Knee injury and Osteoarthritis Outcome Score (KOOS) is a self-administered questionnaire which consists of 42 items which can be sub grouped into five categories. These categories are pain, other disease-specific symptoms, activities of daily living (ADL), sport and recreation function and lastly knee-related quality of life.
Measured: 5 weeks post-surgery
International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC)
The IKDC subjective knee evaluation form is a self-administered questionnaire which contains 18 items divided into 3 subgroups. These subgroups are symptoms, sports and daily activities and the patients current and previous levels of knee function.
Measured: 12 weeks post-surgery
3 dimensional gait analysis
A 10 Oqus camera system by Qualisys, Sweden integrated with 3 Kistler forcplates is used. The primary outcome is peak knee flexion during stance phase for injured leg
Measured: 12 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete Tear, Knee, Anterior Cruciate LigamentStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Joanna Kvist, Linkoeping University
- Investigators
- Joanna Kvist, Professor, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930239
- Sponsor's protocol ID
- dnr 2016/25-31
- Status last verified
- Oct 2016
- First submitted
- 8 Feb 2016
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Initiated Gait Rehabilitation Using the Anti-gravity Treadmill Following an Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT02930239
- Acronym / sponsor ID
- dnr 2016/25-31
- Keywords
- ACL-reconstruction, Gait rehabilitation, Anti Gravity treadmill, ACL-rehabilitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- Mar 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 12 Oct 2016 (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.
A randomized control trial where subjects following an anterior cruciate ligament reconstruction will be randomized to either a control group who will receive the normal rehabilitation or an experimental group who will perform a 2-week gait rehabilitation using the anti-gravity treadmill in addition to the normal rehabilitation. The intervention will be added to the existing care received at Linkoping University Hospital 2 weeks post-surgery, while the evaluation will be performed in week 5 and 12 post-surgery using: a 3D-gait analysis (with the Qualisys software), self-reported function questionnaires and a clinical examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gait rehabilitation | Experimental | Other: Gait rehabilitating with reduced bodyweight, Other: Standardized rehabilitation following an anterior cruciate ligament reconstruction at Linkoping University HospitalWill perform 2 weeks of gait rehabilitation using the anti gravity treadmill. Intervention will start 2 weeks post-surgery. This rehabilitation will be performed simultaneously as the patient receives the standardized rehabilitation at Linkoping University Hospital. |
| Control group | Active comparator | Other: Standardized rehabilitation following an anterior cruciate ligament reconstruction at Linkoping University HospitalWill only receive the standardized rehabilitation at Linkoping University Hospital. |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Anterior cruciate ligament injury occurred a minimum of 3 weeks prior to surgery
Key exclusion criteria (4 listed)
- Previous Anterior cruciate ligament injury
- Other knee injury with restrictions that could interfere with rehabilitation
- Other injury or disease that could interfere with rehabilitation
- Inability to understand the information
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 |
|---|---|---|
| Gait rehabilitating with reduced bodyweightPatients will perform 8 sessions of gait rehabilitation with reduced bodyweight using the anti gravity treadmill during week 2-5 post-surgery. | Other | Gait rehabilitation |
| Standardized rehabilitation following an anterior cruciate ligament reconstruction at Linkoping University HospitalExercises for increased movement and circulation performed on a daily basis. | Other | Control group, Gait rehabilitation |
Primary outcome
3 dimensional gait analysis
Time frame: 5 weeks post-surgery
A 10 Oqus camera system by Qualisys, Sweden integrated with 3 Kistler forcplates is used. The primary outcome is peak knee flexion during stance phase for injured leg
3 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score
Time frame: 5 weeks post-surgery
International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC)
Time frame: 12 weeks post-surgery
3 dimensional gait analysis
Time frame: 12 weeks post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
- Individual participant dataSharing planned: No
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Anterior Cruciate Ligament Rupture
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.
Joanna Kvist, Professor principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gait rehabilitating with reduced bodyweight and Standardized rehabilitation following an anterior cruciate ligament reconstruction at Linkoping University Hospital in people with Complete Tear, Knee, Anterior Cruciate Ligament, run by Linkoeping University at 1 site in Sweden.
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 1 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 12 Oct 2016. 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 Sweden. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 dimensional gait analysis (time frame: 5 weeks post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2016.