NCT06955026

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2025

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 2, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2026

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
Last Updated

May 2, 2025

Status Verified

April 1, 2025

Enrollment Period

1 year

First QC Date

April 24, 2025

Last Update Submit

April 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Adductor muscles maximal voluntary isometric contraction (MVIC)

    Adductor 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)

Secondary Outcomes (6)

  • Abductor muscles maximal voluntary isometric contraction (MVIC)

    Before the study intervention (T0) and after the study intervention lasting for four weeks (T1)

  • Adductor/abductor isometric strength (MVIC) ratio

    Before the study intervention (T0) and after the study intervention lasting for four weeks (T1)

  • Y-balance test (YBT) composite score

    Before the study intervention (T0) and after the study intervention lasting for four weeks (T1)

  • Triple hop test for distance

    After the study intervention lasting for four weeks (T1)

  • Single hop test for distance

    After the study intervention lasting for four weeks (T1)

  • +1 more secondary outcomes

Study Arms (2)

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

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

Other: Hockey slideboard

Interventions

Hockey slideboard combined with BFR training

ACL-R with hockey slideboard training combined with blood flow restriction (BFR)

Hockey slideboard

ACL-R with hockey slideboard training

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spital Municipal Odorheiu Secuiesc

Odorheiu Secuiesc, Romania, 535600, Romania

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Central Study Contacts

Claudia I Nedelcu, Master, BSc

CONTACT

Sebastiano Nutarelli, Master, BSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2025

First Posted

May 2, 2025

Study Start

April 10, 2025

Primary Completion

April 10, 2026

Study Completion

April 15, 2026

Last Updated

May 2, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations