Proprioceptive Training for Gait and Knee Function After Anterior Cruciate Ligament Reconstruction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversiti Sains Malaysia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Standard Rehabilitation
BehavioralA 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.
Proprioceptive Training
BehavioralA 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Control GroupActive comparator 1 intervention
Group B: Proprioceptive Training GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Walking Speed
Walking speed during level walking measured using 3D gait analysis. Unit of measure: meters per second (m/s).
Time frame
Baseline and 12 weeks post-intervention2
Step Length
Step length measured during level walking using 3D gait analysis. Unit of measure: meters (m).
Time frame
Baseline and 12 weeks post-intervention.3
Cadence
Cadence during level walking measured using 3D gait analysis. Unit of measure: steps per minute (steps/min).
Time frame
Baseline and 12 weeks post-intervention.4
Single Support Time
Single support time of the gait cycle measured using 3D gait analysis. Unit of measure: seconds (s).
Time frame
Baseline and 12 weeks post-intervention.Secondary outcomes
1
Changes in isokinetic knee muscle strength
Isokinetic muscle strength of the knee flexors and extensors will be measured using an isokinetic dynamometer at angular velocities of 60°/s and 180°/s. Peak torque values for flexion and extension will be recorded. Changes from baseline to week 12 will be analyzed.
Time frame
Baseline and 12 weeks post-intervention2
Changes in knee joint position sense accuracy
Knee joint position sense will be assessed using a passive joint position reproduction protocol on a Biodex isokinetic dynamometer. Participants will be seated with the hip flexed to approximately 85° and the knee aligned with the dynamometer axis. The device will passively move the lower limb to predetermined target angles (30°, 45°, and 60° of knee flexion) at a constant slow angular velocity (2-5°/s), hold the position for five seconds, and then return the limb to the starting position. With eyes closed and exposed to white noise, participants will indicate when they perceive that the target angle has been reached. The absolute reposition error (degrees) between the target and reproduced angles will be used to represent proprioceptive accuracy, and the variable error (degrees) will be used to quantify intra-trial consistency. Three repetitions will be performed for each target angle, presented in random order.
Time frame
Baseline and 12 weeks post-intervention3
Change in Lysholm Knee Scoring Scale
Knee function will be evaluated using the Lysholm Knee Scoring Scale. This scale ranges from 0 to 100, with higher scores indicating better knee function. The primary analysis will compare the change in Lysholm score from baseline to 12 weeks post-intervention.
Time frame
Baseline and 12 weeks post-intervention4
Change in International Knee Documentation Committee Subjective Knee Form Score
Knee function will also be evaluated using the International Knee Documentation Committee Subjective Knee Form. This scale ranges from 0 to 100, with higher scores indicating better subjective knee function. The primary analysis will compare the change in IKDC score from baseline to 12 weeks post-intervention.
Time frame
Baseline and 12 weeks post-interventionSponsors and contacts
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Source ClinicalTrials.gov
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