Gait-based Evaluation of Early Rehabilitation After ACL Reconstruction

NCT05481918 | Terminated

• 1 other identifier: LSC18_018
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 3

Brief Summary

The objective of this study is to evaluate the regaining of a normal gait within the early rehabilitation (12-13 weeks postsurgical) after reconstruction of the anterior cruciate ligament (ACL). Therefore, two different rehabilitation programs (supervised versus home-based) will be compared. A prospective, parallel-grouped trial with patients´ free choice of postsurgical therapy (home based versus supervised) will be conducted. One group will receive a well supervised, standardized rehabilitation program, while the other group will be instructed in a home-based rehabilitation program. Gait assessments will be carried out 6-7 weeks and 12-13 weeks postsurgical using standard 3D clinical gait analysis. Complementary, gait will also be evaluated using an Inertial Measurement Unit (IMU) three times postsurgical (6-7 weeks, 9-10 weeks, 12-13 weeks). Furthermore, various clinical parameters, like patient reported outcome measures (PROM), knee swelling, range of motion (ROM) will be taken presurgical as well as on days of gait assessment. The study will show the impact of physiotherapeutic therapy on the early normalization of gait after ACL reconstruction. The results may help to build a better understanding of the required physiotherapeutic supervision after ACL surgery and if a home-based therapy can safely be recommended to specific patients.

Conditions

Anterior Cruciate Ligament Reconstruction

Keywords

gait; exercise therapy; anterior cruciate ligament injuries; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Changes in step length

  The primary outcome will be the regaining of a symmetrical step length in 3D gait analysis. Therefor, the symmetry index by Robinson et al. will be used. Data will be collected using a motion capture system (VICON, Oxford, UK), comprising of 12 infrared-cameras at a sampling rate of 150 Hz A full body marker set with a total of 50 retro-reflective spherical markers with a diameter of 14 mm and 9 mm will be attached bilaterally on each participant using double-sided tape. Markers will be placed at bony landmarks according to the manual of the Cleveland Clinic Marker Set and the Plug in Gait model (upper extremity). The 3D marker trajectories of all markers will be reconstructed and processed using the VICON Nexus analysis software (v. 2.5, Oxford, UK). Kinetic data will be collected simultaneously by using three force plates (AMTI, Watertown, USA) at a sampling rate of 1500 Hz.

  6-7 and 12-13 weeks after ACL reconstruction

Secondary Outcomes (12)

• Kinetic gait parameters (3D gait analysis)

  6-7 and 12-13 weeks after ACL reconstruction

• Kinematic gait parameters (3D gait analysis)

  6-7 and 12-13 weeks after ACL reconstruction

• Step length (IMU)

  6-7, 9-10, 12-13 weeks after ACL reconstruction

• Kinematic pelvic parameters (IMU)

  6-7, 9-10, 12-13 weeks after ACL reconstruction

• Temporal gait parameters (3D+IMU)

  6-7, 9-10, 12-13 weeks after ACL reconstruction

Study Arms (2)

Standardized therapy

ACTIVE COMPARATOR

The standardized outpatient rehabilitation program after ACL reconstruction contains 16 physiotherapeutic visits (groups+ individual), exclusively a stationary supervision. Therapies: stationary: 1x individual (30 min); from 2nd to 6th week: 2x individual (30 min), 5x group (30 min), 4x group (30min); From 6th week: 5x group (30 min)

Procedure: Standardized ambulant therapy after ACL reconstruction

Home-based therapy

EXPERIMENTAL

The home-based program consists of five outpatient physiotherapeutic units (each 60 minutes) at the department of physical medicine and rehabilitation of the UHK. The timing of the physiotherapeutic supervisions was defined based on pre-existing studies, concerning home based therapy after ACL reconstruction. The five physiotherapeutic sessions will be executed by a physiotherapist in first, third, seventh, ninth and eleventh postsurgical week. In addition to a general information sheet, the patients of this group will receive phase-adapted training documents (with photographs) at each physiotherapeutic appointment.

Procedure: Home-based therapy after ACL reconstruction

Interventions

Home-based therapy after ACL reconstruction PROCEDURE

Five physiotherapeutic supervisions (individual) take place within the first 12-13 weeks after ACL reconstruction with focus on home exercises

Home-based therapy

Standardized ambulant therapy after ACL reconstruction PROCEDURE

16 physiotherapeutic supervisions (groups+ individual) take place within the first 12-13 weeks after ACL reconstruction.

Standardized therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Surgery at University Hospital Krems (UHK), Austria
• Age 18-60 years
• Surgery-timing less than six months posttraumatic
• Isolated ACL rupture with or without small concomitant injuries

You may not qualify if:

• Relevant concomitant injuries of the musculoskeletal system
• Old injuries of the lower limbs, which influence the normal gait pattern (including ACL re-ruptures)
• Relevant orthopaedic pre-existing conditions, especially of the lower limbs.
• Severe internistic and neurological concomitant diseases, which have an impact on the cardiorespiratory fitness or the physiologic gait
• Patients who do not speak or understand the German or English language properly

Sponsors & Collaborators

• Karl Landsteiner University of Health Sciences: lead
• St. Pölten University of Applied Sciences: collaborator

Study Sites (3)

Department of Biomechanics, Karl Landsteiner University of Health Sciences

Krems, Lower Austria, 3500, Austria

Location

Department of Physical Medicine and Rehabilitation, University Hospital Krems.

Krems, Lower Austria, 3500, Austria

Location

Institute of Health Sciences, Department of Health, St. Pölten University of Applied Sciences

Sankt Pölten, Lower Austria, Austria

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Ursula Ernst, Dr.

  Karl Landsteiner University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: A blinding of the patients is not possible, due to the nature of the study and the obviosity of group allocation. The principal investigator will be blinded to the allocation and will only get access to the coding list in special cases (e.g. harm). Furthermore, the principal investigator is not involved in the statistical analysis of data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: August 1, 2022
• Study Start: February 16, 2021
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: June 18, 2025

Record last verified: 2022-07

Locations

AU (3)