CClinicalTrials.gg
Status unknownNCT03738436Updated Nov 8, 2022

Adding Modified Visual Feedback Training in Patients Following ACL Reconstruction

An interventional study of Physical therapy traditional neuromuscular training, NMT and Physical therapy modified visual feedback, MVF in Anterior Cruciate Ligament Reconstruction, sponsored by China Medical University Hospital. Status unknown at 1 site in Taiwan. Open to male participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-11-08.

Sponsored by China Medical University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Male
01

Study 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.

Read the 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.

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Conditions studied

  • Anterior Cruciate Ligament Reconstruction

Keywords

  • Visual feedback
  • Proprioception
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In context

Lead sponsor

China Medical University Hospital is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • OtherPhysical 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.

    Also known as: The neuromuscular training (NMT) program

  • OtherPhysical 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

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What researchers measure

Primary outcomes

  1. 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)

    Time frame: Change from post-operative 4 weeks to post-operative 13 weeks

  2. 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)

    Time frame: Change from post-operative 4 weeks to post-operative 13 weeks

  3. Maximal muscle strength

    Maximal isometric strength (in torque, Nm) of knee extensor \& flexor will be tested on the isokinetic machine (Biodex System 3)

    Time frame: Change from post-operative 4 weeks to post-operative 13 weeks

  4. 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.

    Time frame: Change from post-operative 4 weeks to post-operative 13 weeks

Secondary outcomes

  1. 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).

    Time frame: Change from post-operative 4 weeks to post-operative 13 weeks

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Study locations

1 of 1 sites recruiting
  • China Medical University Hospital
    Taichung, 404, Taiwan
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03738436
Lead sponsor
China Medical University Hospital
Responsible party
Hsiu-Chen Lin (Associate Professor, China Medical University Hospital) — Principal investigator
First posted
Nov 13, 2018
Start date
Aug 2, 2019
Primary completion
Mar 15, 2023 (estimated)
Completion
Jul 31, 2023 (estimated)
Last update
Nov 8, 2022

Study contacts

Hsiu-Chen Lin, PhD
Contact
hclin@mail.cmu.edu.tw
+886-4-22053366 ext. 7303
Hsiu-Chen Lin, PhD
principal investigator · China Medical University, China

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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