Clinical trial NCT03738436: Adding Modified Visual Feedback Training in Patients Following ACL Reconstruction
Official title: The Effects of Adding Modified Visual Feedback Training in Physical Therapy Protocol Following Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament Reconstruction
Keywords: Visual feedback
Proprioception
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 40
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Position sense (Proprioception) of the knee joints
timeFrame: Change from post-operative 4 weeks to post-operative 13 weeks
measure: Movement sense (Proprioception) of the knee joints
timeFrame: Change from post-operative 4 weeks to post-operative 13 weeks
measure: Maximal muscle strength
timeFrame: Change from post-operative 4 weeks to post-operative 13 weeks
measure: Balance Test
timeFrame: Change from post-operative 4 weeks to post-operative 13 weeks
Secondary outcomes:
measure: Functional outcome questionnaire
timeFrame: Change from post-operative 4 weeks to post-operative 13 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University, China
name: Hsiu-Chen Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References: