- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06955026
Effect of the Hockey Slideboard Training Combined With Blood Flow Restriction (BFR) in the Rehabilitation Following Anterior Cruciate Ligament Surgical Reconstruction (ACL-R)
ACL injuries represent a major health and economic burden. The overall incidence of ACL injuries has increased and is likely to continue to increase, in part due to increased sports participation.
In the acute post-surgical phase there is a period of physiologic recovery from the surgical injury and subsequent relative muscle disuse that is associated with atrophy loss of strength and anterior knee pain. Therefore, improvement of muscle function is a priority in the rehabilitation and reathletization process.
To achieve significant muscle hypertrophy as well as a possible subsequent increase in strength, it is widely accepted that resistance exercises with relevant load (~70% of the one repetition maximum - 1RM) are necessary; however, in patients undergoing anterior cruciate ligament reconstruction (ACL-R), exercises with high loads are considered unsafe in the early stages and could increase the risk of re-injury.
BFR training is an established muscle training and rehabilitation technique in which the blood supply to and from the muscles involved in the exercise is restricted using an external device.
Although the physiological mechanisms related to this intervention are not yet well understood, it is thought that in BFR training, despite the low level of mechanical tension, the main driver of myocellular hypertrophy could be metabolic stress that is realized by local accumulation of metabolites. Thus, it seems that hypertrophic adaptations can be induced with much lower exercise intensities using BFR. In fact, when combined with low-load resistance training (e.g., 20% 1RM), training with BFR has shown positive results in increasing muscle volume and strength after ACL-R in complete safety comparable to standard training without BFR.
It has also already been demonstrated how incorporating the use of the hockey slideboard into the rehabilitation procedure following ACL-R gives benefits in terms of strength recovery of the extensor muscles of the operated limb with the same safety profiles as standard rehabilitation.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Claudia I Nedelcu, Master, BSc
- Phone Number: 0040728258216
- Email: iuliaclaudy@gmail.com
Study Contact Backup
- Name: Sebastiano Nutarelli, Master, BSc
- Phone Number: 0041779501650
- Email: s.nutarelli@mail.ch
Study Locations
-
-
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Odorheiu Secuiesc, Romania, 535600
- Recruiting
- Spital Municipal Odorheiu Secuiesc
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Contact:
- Claudia I Nedelcu, Master, BSc
- Phone Number: 0040728258216
- Email: iuliaclaudy@gmail.com
-
Contact:
- Claudia I Nedelcu, Master, BSc
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Contact:
- Toma Vasilescu, Master, BSc
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- having undergone ACL-R following a unilateral rupture, with reconstructive surgical technique by bone-patellar tendon-bone autograft (BPTB) or semitendinosus-gracilis autograft (STG)
- ACL-R including associated meniscal lesions treated with selective meniscectomy and/or non-complex meniscal suture
Exclusion Criteria:
- not having undergone ACL-R following a unilateral rupture, with reconstructive surgical technique by bone-patellar tendon-bone autograft (BPTB) or semitendinosus-gracilis autograft (STG)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ACL-R with hockey slideboard training combined with blood flow restriction (BFR)
Patients underwent ACL-R who undergo a reathletization program as usual together with the use of the hockey slideboard combined with BFR training
|
Hockey slideboard combined with BFR training
|
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Active Comparator: ACL-R with hockey slideboard training
Patients underwent ACL-R who undergo a reathletization program as usual together with the use of the hockey slideboard
|
Hockey slideboard
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adductor muscles maximal voluntary isometric contraction (MVIC)
Time Frame: Before the study intervention (T0) and after the study intervention lasting for four weeks (T1)
|
Adductor muscles' maximal voluntary isometric contraction (MVIC) measured via hand-held dynamometer test in a supine position
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Before the study intervention (T0) and after the study intervention lasting for four weeks (T1)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Abductor muscles maximal voluntary isometric contraction (MVIC)
Time Frame: Before the study intervention (T0) and after the study intervention lasting for four weeks (T1)
|
Abductor muscles' maximal voluntary isometric contraction (MVIC) measured via hand-held dynamometer test in a supine position
|
Before the study intervention (T0) and after the study intervention lasting for four weeks (T1)
|
|
Adductor/abductor isometric strength (MVIC) ratio
Time Frame: Before the study intervention (T0) and after the study intervention lasting for four weeks (T1)
|
Adductor and abductor muscles' maximal voluntary isometric (MVIC) strength ratio measured via hand-held dynamometer test in a supine position
|
Before the study intervention (T0) and after the study intervention lasting for four weeks (T1)
|
|
Y-balance test (YBT) composite score
Time Frame: Before the study intervention (T0) and after the study intervention lasting for four weeks (T1)
|
The YBT assessment demands that the athlete maintain balance on one leg while extending the opposite leg as far as feasible in three different directions: anterior, posterolateral, and posteromedial.
The YBT composite score is calculated by summing the three reach distances and normalizing them to the lower limb length.
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Before the study intervention (T0) and after the study intervention lasting for four weeks (T1)
|
|
Triple hop test for distance
Time Frame: After the study intervention lasting for four weeks (T1)
|
Triple hop test executed, calculating the maximum reached distance and comparing the healthy limb result with the involved leg.
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After the study intervention lasting for four weeks (T1)
|
|
Single hop test for distance
Time Frame: After the study intervention lasting for four weeks (T1)
|
Single hop test executed, calculating the maximum reached distance and comparing the healthy limb result with the involved leg.
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After the study intervention lasting for four weeks (T1)
|
|
Side hop test
Time Frame: After the study intervention lasting for four weeks (T1)
|
The participant is required to hop from side to side on one limb outside two parallel strips of tape 40 cm apart, and instructed to hop as many hops as possible for 30 seconds.
|
After the study intervention lasting for four weeks (T1)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SOCT1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Hockey slideboard combined with BFR training
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Majmaah UniversityCompletedLateral Epicondylitis (Tennis Elbow) | Extensor Carpi Radialis Brevis (ECRB) | Elbow Pain | Lateral Elbow TendinopathySaudi Arabia
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Paulista UniversityCompleted
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Cairo UniversityCompletedMetabolic Syndrome X | Cardiovascular Problems in ElderlyEgypt
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University of Gran RosarioCompleted
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AspetarRecruitingPatellofemoral Pain Syndrome | Knee Pain Chronic | Rotator Cuff Tendinosis | Rotator Cuff Impingement Syndrome | Anterior Knee Pain SyndromeQatar
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Uppsala UniversityNanjing Sport Institute; Nanjing Maigaoqiao Community Health Service CenterCompleted
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European University CyprusCompletedShoulder Pain | Shoulder Impingement | BFRCyprus
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Istanbul Medipol University HospitalBahçeşehir University; Medipol UniversityRecruitingExercise Training | Geriatrics | Blood Flow Restriction TrainingTurkey
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Bahçeşehir UniversitySüreyyapaşa Sports ClubCompletedJump Performance, Agility, Balance, Blood Flow Restriction, FatigueTurkey