NCT06726044

Brief Summary

The primary aim of the study was to compare the effectiveness of two rehabilitation protocols for patients following ACL reconstruction. The first group (SR) underwent standard rehabilitation, which included the following treatments: Manual therapy: manual mobilization of the patella and fibular head Anti-swelling therapy: manual lymphatic drainage techniques Compression and cryotherapy Reflex therapy: clavi-therapy Kinesiotherapy: strength exercises Kinesiotaping Osteopathic techniques Myofascial release Manual scar treatment Activation of gliding movement in the knee joint; soft tissue techniques in the popliteal region Flossing Knee flexion and extension exercises in a closed and next in open kinematic chain Isometric quadriceps exercises at full extension and 45-degree flexion In addition to the above, the second group (SR+I) performed inertial exercises, which were introduced starting from the fifth week of rehabilitation. After 12 weeks of rehabilitation, its effectiveness was evaluated using standard tests. The results indicate that the innovative rehabilitation protocol incorporating inertial exercises can be effectively applied in the rehabilitation of individuals following arthroscopic ACL reconstruction. None of the monitored rehabilitation effectiveness indicators in the SR+I group were inferior to those in the SR group. Moreover, certain parameters assessing rehabilitation effectiveness showed the SR+I protocol to have advantages over the SR protocol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

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 2, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2024

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

11 months

First QC Date

December 5, 2024

Last Update Submit

December 13, 2024

Conditions

Keywords

ACL reconstruction

Outcome Measures

Primary Outcomes (1)

  • Knee extensors anf flexors strength under isokinetic and inertial conditions.

    After 12 weeks of rehabilitation, muscle strength was assessed in all patients under isokinetic and inertial conditions. Measurements were conducted following these guidelines: * Isokinetic measurements at two speeds: of 60˚/s, and 180˚/s, with five repetitions of flexion and extension for each limb and each speed in a seated position, * the axis of rotation of the dynamometer was aligned with the axis of rotation of the knee joint. * patients performed trial repetitions to familiarize themselves with the movement speed and range of motion. the range of motion was consistently set at 60˚, starting from a knee flexion angle of 90˚ ± 30˚. * patients were secured using crossed straps, a hip belt, and a limb-specific belt. * only the patient and the examiner are allowed in the room during the measurement process The patient's arms were crossed on the chest during the measurement. Testing began with the healthy limb and concluded with the operated limb. Patients

    12 weeks of rehabilitation

Secondary Outcomes (1)

  • Body balance, stability and mobility after rehabilitation

    12 weeks of rehabilitation

Study Arms (2)

Standard rehabilitation

ACTIVE COMPARATOR

12 subjects after ACL reconstruction. Subjects participated in standard rehabilitation program twice a week for 12 weeks. Each session lasted approximately 60 minutes.

Other: Standard rehabilitaion after ACL reconstructionOther: Standard rehabilitaion after ACL reconstruction plus inertial exercises

Standard rehabilitation and inertial exercises

EXPERIMENTAL

12 subjects after ACL reconstruction. Subjects participated in standard rehabilitation program twice a week for 12 weeks and additionally performed inertial exercises from the fifth week of rehabilitation. Then each session lasted approximately 70 minutes.

Other: Standard rehabilitaion after ACL reconstructionOther: Standard rehabilitaion after ACL reconstruction plus inertial exercises

Interventions

The SR group, consisting of 12 participants, underwent a standard rehabilitation program twice a week for 12 weeks. Each session lasted approximately 60 minutes and was conducted by the same therapist. After 12 weeks of rehabilitation, effectiveness was evaluated using standard tests. Before rehabilitation involving kinesiotherapy (two weeks post-surgery), the following measurements were conducted: Height and body weight Thigh circumference measurements Assessment of muscle and tendon stiffness Body composition evaluation After the rehabilitation the following measurements and assessments were conducted: Body weight Thigh circumference measurements Assessment of muscle and tendon stiffness Body composition evaluation Evaluation of the strength of knee extensor and flexor muscles under isokinetic conditions Evaluation of knee extensor strength under inertial conditions Postural stability assessment

Standard rehabilitationStandard rehabilitation and inertial exercises

The SR+I group, consisting of 12 participants, underwent a standard rehabilitation program twice a week for 12 weeks including inertial exercises. Each session lasted approximately 70 minutes and was conducted by the same therapist. Subjects also performed inertial exercises from the fifth week of rehabilitation. These exercises were conducted on an InerKnee. The inertial exercises protocol included: knee extension exercises performed in a seated position for the operated leg, 4 sets of exercises, each lasting 15 seconds individually, adjusted resistance to maintain a 1-second extension cycle, passive rest periods of 2 minutes between sets After 12 weeks of rehabilitation, effectiveness was evaluated using standard tests the same as in SR group.

Standard rehabilitationStandard rehabilitation and inertial exercises

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ACL reconstruction performed by the same doctor using similar technique, lack of other disases, minimum 90% attendance in rehabilitation sessions

You may not qualify if:

  • other chronic disases, rehabilitation was not completed, other injury during rehabilitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Education and Sport, Faculty in Gorzow Wielkopolski, Poznan University of Physical Education, Poznan, Poland

Gorzów Wielkopolski, 66-400, Poland

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study finally included 24 people after ACL reconstruction. All of them participated in 12 - week rehabilitation; SR - standard rehabilitation, SR+I - standard rehabilitation and inertial exercises
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 5, 2024

First Posted

December 10, 2024

Study Start

April 2, 2022

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

December 18, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

All data from research excluding private data; names etc.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
After publication these data in article, we suppose from 2025
Access Criteria
from the corresponding author

Locations