Adding Modified Visual Feedback Training in Patients Following ACL Reconstruction

NCT ID: NCT03738436

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-02
• Study Completion Date: 2023-07-31

Brief Summary

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.

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.

Conditions

Anterior Cruciate Ligament Reconstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Physical therapy traditional neuromuscular training, NMT

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Physical therapy modified visual feedback, MVF

Intervention Type: OTHER

traditional neuromuscular training (as in NMT group), but with modified visual feedback by eyes closed, reduced lighting or wearing strobe goggles

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

Other Intervention Names

The neuromuscular training (NMT) program

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hsiu-Chen Lin

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hsiu-Chen Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

China Medical University, China

Locations

China Medical University Hospital

Taichung, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Hsiu-Chen Lin, PhD

Role: CONTACT

hclin@mail.cmu.edu.tw

+886-4-22053366 ext. 7303

Facility Contacts

Hsiu-Chen Lin, PhD

Role: primary

hclin@mail.cmu.edu.tw

+886-4-22053366 ext. 7303

Other Identifiers

CMUH107-REC3-124

Identifier Type: -

Identifier Source: org_study_id