Adding Modified Visual Feedback Training in Patients Following ACL Reconstruction

November 7, 2022 updated by: Hsiu-Chen Lin, China Medical University Hospital

The Effects of Adding Modified Visual Feedback Training in Physical Therapy Protocol Following Anterior Cruciate Ligament Reconstruction

The current treatment for the ACL-injured patients usually emphasize on the movement quality through neuromuscular training. The purpose of this study is to (1) design a modified visual feedback training program and (2) investigate the effects of the modified visual feedback training on the movement control in the ACL-reconstructed (ACL-R) patients. Forty unilateral ACL-R male patients will be enrolled voluntarily, who will be randomly allocated into the traditional neuromuscular training (NMT) or the modified visual feedback (MVF) group. The investigators hypothesize that this MVF training program will have better potential to improve their post-injury movement dysfunction.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Anterior cruciate ligament (ACL) rupture is a common sport-related injury that needs surgical reconstruction to restore a better knee function. This ligament accommodates plenty of crucial sensory nerve endings providing proprioceptive information to central nerve system (CNS) for the knee movement control. Recent studies have found that the patients will increase utilization of the visual processing for movement control, concurrent with the depression of the proprioceptive information after the ACL injury. In addition, the loss of proprioception information will result in motor impairment when disrupting vision during more demanding physical activities, such as pivoting, accelerating, decelerating, and landing maneuver. It is obvious that this motor control deficit may increase the re-injury risk during multitasking situations common in functional movements or sports participation. The current treatment for the ACL-injured patients usually emphasize on the movement quality through neuromuscular training, but seldom adding the alteration of the sensory processing. Some patients still have been forced to lower their activity level or ended their career in sports due to the remained motor control problems after rehabilitation. Therefore, the purpose of this study is to (1) design a modified visual feedback training program and (2) investigate the effects of the modified visual feedback training on the movement control in the ACL-reconstructed (ACL-R) patients. Forty unilateral ACL-R male patients will be enrolled voluntarily from local hospitals to participate in this study. Each participant will be randomly allocated into the traditional neuromuscular training (NMT) or the modified visual feedback (MVF) group. The training program will start at the forth week after the ACL reconstruction and last for eight weeks. The hypothesis of this study is that the MVF training program will have better potential to improve their post-injury movement dysfunction and thus may decrease the re-injury risk in ever-changing environment. Therefore, it may provide assistance for the patients to build both physical and neurocognitive capabilities for returning to sport.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taichung, Taiwan, 404
        • Recruiting
        • China Medical University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • unilateral ACL injury male patients aged from 20~45 years old
  • arthroscopic assisted ACL reconstruction with autologous patellar tendon or hamstring tendon graft
  • no other knee injury
  • no limited range of motion at the hip or ankle joints

Exclusion Criteria:

  • injuries in the other knee joint
  • previous injuries in the ipsilateral hip or ankle joints
  • neurological disease that affects his motor function

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Active Comparator: traditional neuromuscular training, NMT
Eight-week physical therapy program consisted of neuromuscular training (NMT) starting from 4 weeks post-surgery. The NMT program includes re-position exercise, strengthening, stretching, landing and balance training.
Other: Physical therapy traditional neuromuscular training, NMT
The NMT program includes re-position exercise using Swiss ball roll squat, strengthening and stretching exercises in various positions or combined using Swiss ball, Thera-Band or suspension system (Redcord), balance exercise on wobble board, proper landing strategy practices, and etc.
Other Names:
  • The neuromuscular training (NMT) program
Experimental: modified visual feedback, MVF
Starting from 4 weeks post-surgery, eight-week physical therapy program consisted of traditional neuromuscular training (as in NMT group), but with modified visual feedback by eyes closed, reduced lighting or wearing strobe goggles.
Other: Physical therapy modified visual feedback, MVF
traditional neuromuscular training (as in NMT group), but with modified visual feedback by eyes closed, reduced lighting or wearing strobe goggles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Position sense (Proprioception) of the knee joints
Time Frame: Change from post-operative 4 weeks to post-operative 13 weeks
It will be performed on a isokinetic machine (Biodex System 3) to obtain the error angles (degrees) in the test of the joint position reproduction (JPR)
Change from post-operative 4 weeks to post-operative 13 weeks
Movement sense (Proprioception) of the knee joints
Time Frame: Change from post-operative 4 weeks to post-operative 13 weeks
It will be performed on a isokinetic machine (Biodex System 3) to obtain the angles (in degrees) in the test of threshold to detection of passive motion (TTDPM)
Change from post-operative 4 weeks to post-operative 13 weeks
Maximal muscle strength
Time Frame: Change from post-operative 4 weeks to post-operative 13 weeks
Maximal isometric strength (in torque, Nm) of knee extensor & flexor will be tested on the isokinetic machine (Biodex System 3)
Change from post-operative 4 weeks to post-operative 13 weeks
Balance Test
Time Frame: Change from post-operative 4 weeks to post-operative 13 weeks
Y Balance Test (YBT) - The test requires the participant to balance on one leg while reaching as far as possible with the other leg in three separate directions: anterior, posterolateral, and posteromedial. The composite score (in percentage, %) of summarized reaching distances, each divided by leg length first, in three directions will be recorded.
Change from post-operative 4 weeks to post-operative 13 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional outcome questionnaire
Time Frame: Change from post-operative 4 weeks to post-operative 13 weeks
A self-administered 14-item questionnaire - Knee Outcome Survey - Activities of Daily Living Scale (KOS-ADLS) will be used to evaluate the symptom-related (6 items) and specific functional limitations during ADL (8 items). The responses are graded on a 6-point Likert scale (0 to 5 points), with 5 indicating no symptom or limitation and 0 indicating the severest limitation. The total score is 70 points, and then will be transformed to a 0- to 100-point scale (percentage of disability).
Change from post-operative 4 weeks to post-operative 13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Investigators

  • Principal Investigator: Hsiu-Chen Lin, PhD, China Medical University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2019

Primary Completion (Anticipated)

March 15, 2023

Study Completion (Anticipated)

July 31, 2023

Study Registration Dates

First Submitted

October 31, 2018

First Submitted That Met QC Criteria

November 9, 2018

First Posted (Actual)

November 13, 2018

Study Record Updates

Last Update Posted (Actual)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CMUH107-REC3-124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Anterior Cruciate Ligament Reconstruction

Clinical Trials on Physical therapy traditional neuromuscular training, NMT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe