Anterior Cruciate Ligament RuptureNCT06955026
Effect of the Hockey Slideboard Training Combined With Blood Flow Restriction (BFR) in the Rehabilitation Following Anterior Cruciate Ligament Surgical Reconstruction (ACL-R)
A study testing Hockey slideboard combined with BFR training and Hockey slideboard in people with Anterior Cruciate Ligament Rupture and Rehabilitation After ACL Reconstruction, run by Spitalul Municipal Odorheiu Secuiesc at 1 site in Romania.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture, Rehabilitation After ACL Reconstruction
- What is being tested?
- Hockey slideboard combined with BFR training and Hockey slideboard
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteRomania
- Study dates
- 10 Apr 2025to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site, 1 recruiting
- Recruiting
Spital Municipal Odorheiu Secuiesc
Odorheiu Secuiesc, Romania, 535600
Claudia I Nedelcu, Master, BSc, 0040728258216, iuliaclaudy@gmail.com
Claudia I Nedelcu, Master, BSc
About this study
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.
Read more
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.
- Being tested
- Hockey slideboard combined with BFR training, Hockey slideboard
- 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.
Hockey slideboard combined with BFR trainingOther
Hockey slideboard combined with BFR training
Hockey slideboardOther
Hockey slideboard
| Study group | Role | What they receive |
|---|---|---|
| ACL-R with hockey slideboard training combined with blood flow restriction (BFR) | Experimental | Patients underwent ACL-R who undergo a reathletization program as usual together with the use of the hockey slideboard combined with BFR training Receives: Other: Hockey slideboard combined with BFR training |
| ACL-R with hockey slideboard training | Active comparator | Patients underwent ACL-R who undergo a reathletization program as usual together with the use of the hockey slideboard Receives: Other: Hockey slideboard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adductor muscles maximal voluntary isometric contraction (MVIC)
Adductor muscles' maximal voluntary isometric contraction (MVIC) measured via hand-held dynamometer test in a supine position
Measured: Before the study intervention (T0) and after the study intervention lasting for four weeks (T1)
Secondary outcomes (6)
Abductor muscles maximal voluntary isometric contraction (MVIC)
Abductor muscles' maximal voluntary isometric contraction (MVIC) measured via hand-held dynamometer test in a supine position
Measured: Before the study intervention (T0) and after the study intervention lasting for four weeks (T1)
Adductor/abductor isometric strength (MVIC) ratio
Adductor and abductor muscles' maximal voluntary isometric (MVIC) strength ratio measured via hand-held dynamometer test in a supine position
Measured: Before the study intervention (T0) and after the study intervention lasting for four weeks (T1)
Y-balance test (YBT) composite score
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.
Measured: Before the study intervention (T0) and after the study intervention lasting for four weeks (T1)
Triple hop test for distance
Triple hop test executed, calculating the maximum reached distance and comparing the healthy limb result with the involved leg.
Measured: After the study intervention lasting for four weeks (T1)
Single hop test for distance
Single hop test executed, calculating the maximum reached distance and comparing the healthy limb result with the involved leg.
Measured: After the study intervention lasting for four weeks (T1)
Side hop test
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.
Measured: After the study intervention lasting for four weeks (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start10 Apr 2025
- Primary completion10 Apr 2026 (estimated)
- Study completion15 Apr 2026 (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 RuptureStudies 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spitalul Municipal Odorheiu Secuiesc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955026
- Sponsor's protocol ID
- SOCT1
- Status last verified
- Apr 2025
- First submitted
- 24 Apr 2025
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- 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 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Hockey Slideboard Training Combined With Blood Flow Restriction (BFR) in the Rehabilitation Following Anterior Cruciate Ligament Surgical Reconstruction (ACL-R)
- ClinicalTrials.gov ID
- NCT06955026
- Acronym / sponsor ID
- SOCT1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Spitalul Municipal Odorheiu SecuiescUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 10 Apr 2026 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 2 May 2025 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACL-R with hockey slideboard training combined with blood flow restriction (BFR) | Experimental | Other: Hockey slideboard combined with BFR trainingPatients underwent ACL-R who undergo a reathletization program as usual together with the use of the hockey slideboard combined with BFR training |
| ACL-R with hockey slideboard training | Active comparator | Other: Hockey slideboardPatients underwent ACL-R who undergo a reathletization program as usual together with the use of the hockey slideboard |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
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 |
|---|---|---|
| Hockey slideboard combined with BFR trainingHockey slideboard combined with BFR training | Other | ACL-R with hockey slideboard training combined with blood flow restriction (BFR) |
| Hockey slideboardHockey slideboard | Other | ACL-R with hockey slideboard training |
Primary outcome
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
6 secondary outcomes
Abductor muscles maximal voluntary isometric contraction (MVIC)
Time frame: 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)
Y-balance test (YBT) composite score
Time frame: 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)
Single hop test for distance
Time frame: After the study intervention lasting for four weeks (T1)
Side hop test
Time frame: After the study intervention lasting for four weeks (T1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hockey slideboard combined with BFR training and Hockey slideboard in people with Anterior Cruciate Ligament Rupture and Rehabilitation After ACL Reconstruction, run by Spitalul Municipal Odorheiu Secuiesc at 1 site in Romania.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 2 May 2025. 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 Romania. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudia I Nedelcu, Master, BSc (0040728258216, iuliaclaudy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adductor muscles maximal voluntary isometric contraction (MVIC) (time frame: Before the study intervention (T0) and after the study intervention lasting for four weeks (T1)). 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 2025.