Adding Modified Visual Feedback Training in Patients Foll... | NCT03738436

NCT03738436

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

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.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
traditional neuromuscular training, NMT	Active Comparator	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
modified visual feedback, MVF	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Physical therapy traditional neuromuscular training, NMT	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Position sense (Proprioception) of the knee joints	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	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	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	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 Outcomes

Measure	Description	Time Frame
Functional outcome questionnaire	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).

Eligibility Module