NCT07268651

Brief Summary

Anterior cruciate ligament reconstruction (ACLR) is commonly performed to restore knee stability after injury, but many patients continue to experience gait abnormalities and reduced knee function during rehabilitation. Proprioceptive training is frequently included in rehabilitation programs to improve joint position sense, neuromuscular control, and movement coordination, yet its specific effects on gait performance and knee function after ACLR are not fully understood. This study aims to investigate the effects of a 12-week proprioceptive training program on gait performance and knee function in patients who have undergone ACLR. Patients who meet the inclusion criteria will undergo baseline assessments, including gait analysis and knee function tests. They will then participate in a structured 12-week proprioceptive training program as part of their rehabilitation, followed by post-intervention assessments using the same measures. The primary outcomes include changes in gait performance, such as walking speed, step length, cadence, support time, knee motion, and knee joint angles and moments during walking. Secondary outcomes include changes in knee function, including isokinetic muscle strength, joint position sense, and patient-reported outcomes measured by the Lysholm score and the International Knee Documentation Committee (IKDC) questionnaire. The findings from this study may help to clarify the functional benefits of proprioceptive training and support the development of more targeted and effective rehabilitation strategies for patients recovering from Anterior cruciate ligament (ACL) injuries.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

December 8, 2025

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

November 18, 2025

Last Update Submit

December 4, 2025

Conditions

Keywords

Proprioceptive TrainingGait PerformanceKnee FunctionJoint Position Sense

Outcome Measures

Primary Outcomes (10)

  • Walking Speed

    Walking speed during level walking measured using 3D gait analysis. Unit of measure: meters per second (m/s).

    Baseline and 12 weeks post-intervention

  • Step Length

    Step length measured during level walking using 3D gait analysis. Unit of measure: meters (m).

    Baseline and 12 weeks post-intervention.

  • Cadence

    Cadence during level walking measured using 3D gait analysis. Unit of measure: steps per minute (steps/min).

    Baseline and 12 weeks post-intervention.

  • Single Support Time

    Single support time of the gait cycle measured using 3D gait analysis. Unit of measure: seconds (s).

    Baseline and 12 weeks post-intervention.

  • Double Support Time

    Double support time of the gait cycle measured using 3D gait analysis. Unit of measure: seconds (s).

    Baseline and 12 weeks post-intervention.

  • Peak Knee Flexion Angle

    Peak knee flexion angle during the stance phase measured using 3D gait analysis. Unit of measure: degrees (°).

    Baseline and 12 weeks post-intervention.

  • Peak Knee Extension Angle

    Peak knee extension angle during the stance phase measured using 3D gait analysis. Unit of measure: degrees (°).

    Baseline and 12 weeks post-intervention.

  • Peak Knee Flexion Moment

    Peak external knee flexion moment measured during walking using 3D gait analysis. Unit of measure: Newton-meters per kilogram (Nm/kg).

    Baseline and 12 weeks post-intervention.

  • Peak Knee Extension Moment

    Peak external knee extension moment measured during walking using 3D gait analysis. Unit of measure: Newton-meters per kilogram (Nm/kg).

    Baseline and 12 weeks post-intervention.

  • Knee Range of Motion

    Total sagittal plane knee range of motion measured during level walking using 3D gait analysis. Unit of measure: degrees (°).

    Baseline and 12 weeks post-intervention.

Secondary Outcomes (4)

  • Changes in isokinetic knee muscle strength

    Baseline and 12 weeks post-intervention

  • Changes in knee joint position sense accuracy

    Baseline and 12 weeks post-intervention

  • Change in Lysholm Knee Scoring Scale

    Baseline and 12 weeks post-intervention

  • Change in International Knee Documentation Committee Subjective Knee Form Score

    Baseline and 12 weeks post-intervention

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Participants in this arm will receive a standard rehabilitation program adapted from the Massachusetts General Brigham Sports Medicine Anterior cruciate ligament Reconstruction Rehabilitation Protocol. The rehabilitation sessions will be conducted twice per week. The 12-week program is delivered in four progressive phases focusing on graft protection, restoration of knee range of motion, quadriceps activation, balance, and strengthening exercises. No additional proprioceptive training will be provided in this arm.

Behavioral: Standard Rehabilitation

Proprioceptive Training Group

EXPERIMENTAL

Participants in this arm will receive a structured 12-week proprioceptive training program in addition to the standard rehabilitation protocol. The proprioceptive training is adapted from validated progressive exercise programs using Swiss balls and BOSU balls, and includes balance, coordination, and neuromuscular control exercises. Training sessions are supervised by a physiotherapist and performed three times per week. The progression follows three stages (initial: weeks 1-5, intermediate: weeks 5-8, advanced: weeks 8-12), with advancement allowed only when exercises can be performed with adequate balance control and without pain.

Behavioral: Standard RehabilitationBehavioral: Proprioceptive Training

Interventions

A standard rehabilitation program adapted from the Massachusetts General Brigham Sports Medicine Anterior cruciate ligament Reconstruction Rehabilitation Protocol. The program consists of supervised rehabilitation sessions conducted twice per week for 12 weeks. The protocol includes four progressive phases focusing on graft protection, restoration of knee range of motion, quadriceps activation, balance training, and progressive strengthening exercises. No proprioceptive training components are included in this intervention.

Control GroupProprioceptive Training Group

A structured 12-week proprioceptive training program performed in addition to standard rehabilitation. The program is adapted from validated progressive proprioceptive exercise protocols using Swiss balls and BOSU balls. Training sessions are supervised by a physiotherapist and conducted three times per week. Exercises progress through three stages (initial: weeks 1-5, intermediate: weeks 5-8, and advanced: weeks 8-12) and include balance, coordination, and neuromuscular control activities. Participants advance to the next level only when exercises can be performed with adequate balance control and without pain.

Proprioceptive Training Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged 18-40 years who have undergone primary unilateral anterior cruciate ligament reconstruction (ACLR) using an autograft.
  • At least 3 weeks postoperatively and currently engaged in the early-stage rehabilitation phase following ACLR.
  • Demonstrate near-full passive knee extension (≤ 5° loss) and at least 90° of passive knee flexion in the operated limb.
  • Able to walk independently without assistive devices and perform basic functional tasks (e.g., normal walking, single-leg stance).
  • No prior surgery or major injury to the contralateral knee or other lower limb joints.
  • No neurological, vestibular, or systemic conditions affecting proprioception, motor control, or physical performance.
  • Not currently participating in any structured proprioceptive or neuromuscular training programs.
  • Willing and able to comply with the intervention protocol and follow-up, and able to provide written informed consent.

You may not qualify if:

  • History of revision anterior cruciate ligament surgery, bilateral ACLR, or concurrent reconstruction of other knee ligaments (e.g., posterior cruciate ligament, medial collateral ligament, lateral collateral ligament) in the affected knee.
  • Meniscal repair or other intra-articular procedures that restrict knee range of motion beyond 3 weeks postoperatively.
  • Diagnosed osteoarthritis, rheumatoid arthritis, or other chronic joint diseases affecting the lower limbs.
  • Significant injury, surgery, or persistent pain in the contralateral knee, hip, ankle, or spine that could interfere with training or gait.
  • History or current diagnosis of neurological disorders (e.g., stroke, multiple sclerosis, Parkinson's disease) or vestibular dysfunction.
  • Any cardiopulmonary or systemic condition that contraindicates structured physical exercise.
  • Participation in other structured rehabilitation or proprioceptive training programs within the past 3 weeks.
  • Cognitive impairment or psychiatric conditions that may interfere with understanding instructions or complying with the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leshan Vocational College

Leshan, Sichuan, 614000, China

Location

Study Officials

  • Shazlin Shaharudin, PhD

    Universiti Sains Malaysia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

November 18, 2025

First Posted

December 8, 2025

Study Start

December 1, 2025

Primary Completion

March 1, 2026

Study Completion

April 1, 2026

Last Updated

December 8, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

The individual participant data from this randomized controlled trial on proprioceptive training after anterior cruciate ligament reconstruction will not be shared due to concerns about participant privacy and the lack of an approved institutional framework for public data sharing.

Locations