Adding Modified Visual Feedback Training in Patients Following ACL Reconstruction

NCT03738436 | Unknown

• 1 other identifier: CMUH107-REC3-124
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Reconstruction

Keywords

Visual feedback; Proprioception

Outcome Measures

Primary Outcomes (4)

• 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 (1)

• Functional outcome questionnaire

  Change from post-operative 4 weeks to post-operative 13 weeks

Study Arms (2)

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

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.

Also known as: The neuromuscular training (NMT) program

traditional neuromuscular training, NMT

Physical therapy modified visual feedback, MVF OTHER

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

modified visual feedback, MVF

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

RECRUITING

Study Officials

• Hsiu-Chen Lin, PhD

  China Medical University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsiu-Chen Lin, PhD

CONTACT

+886-4-22053366; hclin@mail.cmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 13, 2018
• Study Start: August 2, 2019
• Primary Completion: March 15, 2023
• Study Completion: July 31, 2023
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)