ACL - Anterior Cruciate Ligament RuptureNCT06755398
The Effect of Cognitive-Based Neuromuscular Exercises on Reaction Time, Joint Position Sense, Proprioceptive Force Sense and Balance in Individuals Who Had Anterior Cruciate Ligament Surgery
A study testing Exercise in people with ACL - Anterior Cruciate Ligament Rupture, run by Ertuğrul Demirdel at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effects of cognitive-based neuromuscular exercises on increased reaction time, decreased joint position sense, reduced proprioceptive force sense, and balance problems in individuals who have undergone surgery following anterior cruciate ligament (ACL) injuries. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- ACL - Anterior Cruciate Ligament Rupture
- What is being tested?
- Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having sustained a unilateral isolated anterior cruciate ligament injury,
- Having undergone anterior cruciate ligament reconstruction using a hamstring graft by a surgeon at least 8 weeks ago,
- Having completed the early phase of the postoperative criterion-based rehabilitation protocol and met the criteria for progression to the intermediate phase of the rehabilitation program (1- pain between 0-2 on the numeric pain scale, 2- no effusion in the knee, 3- no limitation in passive knee extension, 4- passive knee flexion of at least 120°, 5- full quadriceps activation (patient able to perform 10 repetitions of a single-leg raise exercise), and 6- normalized gait pattern without assistance).
Who cannot join
- Having a partial ACL tear,
- Having sustained bilateral ACL injuries,
- Having additional injuries accompanying the ACL injury,
- Having undergone ACL revision surgery,
- Having a history of complex knee surgery,
- Having any neurological, orthopedic, or systemic disease that may contraindicate exercise.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate the effects of cognitive-based neuromuscular exercises on increased reaction time, decreased joint position sense, reduced proprioceptive force sense, and balance problems in individuals who have undergone surgery following anterior cruciate ligament (ACL) injuries. With the results obtained from the study, the investigators aim to provide a different perspective on rehabilitation methods applied after ACL reconstruction and contribute to the literature with objective and evidence-based information regarding the effects of cognitive-based neuromuscular exercises on sensorimotor, neuromuscular, and proprioceptive senses.
Read the detailed description
Anterior Cruciate Ligament (ACL) injuries are among the most common knee injuries, occurring due to both contact and non-contact mechanisms, such as sudden deceleration, changes in direction, or landing after jumping, and leading to disruptions in knee stability and biomechanics. In the United States, it is estimated that there are between 100,000 and 200,000 cases annually, while the global incidence of ACL ruptures approaches 2 million cases per year. Treatment for ACL injuries can be either conservative or surgical. Conservative treatment is considered a viable option for specific populations, such as athletes who do not engage in activities requiring direction changes, individuals with no significant knee instability, and those with lower activity levels. ACL injuries result in quadriceps and hamstring weakness, reduced knee joint proprioception, and impaired balance.
To restore the anatomy and biomechanics of the knee, arthroscopic ACL reconstruction is performed to stabilize the knee and prevent secondary injuries, with approximately 30,000 procedures conducted annually in the United Kingdom. Although comprehensive rehabilitation is a critical component of ACL injury management, whether treated conservatively or surgically, there is currently no gold standard rehabilitation approach for such a widespread injury.
The type of rehabilitation protocol applied is one of the most significant factors influencing the outcomes of ACL reconstruction. Rehabilitation protocols have evolved substantially over the past few decades, with traditional rehabilitation, accelerated rehabilitation, and criterion-based rehabilitation protocols being the most commonly employed. These protocols aim to enhance muscle strength, improve proprioception, and ensure knee stabilization, with the timing and types of exercises determined by the biological healing and remodeling periods of the graft.
Criterion-based rehabilitation protocols, a relatively new approach, aim to provide patient-specific rehabilitation and maximize progress. Developed in 2016 by the Royal Dutch Society for Physical Therapy (KNGF), this protocol is divided into three phases: early, mid, and late stages. To progress to the next stage, patients must meet specific goals for each phase, which are verified through objective and subjective testing. The effectiveness and quality of early and mid-stage rehabilitation significantly influence long-term outcomes. The goals of early-stage rehabilitation, lasting approximately two months, include reducing effusion, restoring joint range of motion, and minimizing muscle atrophy. During the mid-stage, which extends from the second to the sixth month, the focus shifts to achieving full control of knee extension, restoring 80% of the muscle strength in the operated limb compared to the uninjured side, and regaining jumping ability. This phase includes exercises such as knee flexor and extensor strengthening, closed kinetic chain exercises, functional exercises, balance training, plyometric exercises, and neuromuscular exercises.
Neuromuscular control is essential for initiating movement and requires the integration of sensory information from proprioceptive, kinesthetic, visual, and vestibular sources, as well as cortical and spinal motor commands. This control is critical for the effective execution of movement. Recent studies indicate that ACL injuries are not isolated joint damages that merely affect stability and biomechanics but also directly influence neuromuscular control of the knee via mechanoreceptors located within the ACL. These injuries lead to neurophysiological effects on sensorimotor control. Following ACL injuries, these somatosensory changes may result in deficits in postural and motor control, leading to slower lower extremity reaction times. Additionally, nociceptive activity related to pain and swelling, combined with reduced joint position sense and kinesthesia, impairs movement quality. Neuromuscular control impairments, proprioceptive deficits, and disruptions in somatosensory inputs due to damaged mechanoreceptors may persist for 9-12 months, highlighting the need for targeted exercises during the mid-stage rehabilitation.
The complex integration of vestibular, visual, and somatosensory inputs, necessary for situational awareness, enhanced alertness, and the ability to select between attentional resources, can promote the development of neurocognitive functions. Cognitive-based neuromuscular exercises aim to improve patients' reaction times, joint position sense, proprioceptive strength, and neurocognitive functions such as balance, while enhancing motor control and knee stability. An example of cognitive-based neuromuscular exercises is the Life Kinetik (LK) method, developed by Lutz in Germany in 2007. This method is used to promote neural learning, support neuroplasticity, and reduce neurological symptoms. During these exercises, visual or cognitive tasks are combined with physical activity to train the brain, aiming to enhance concentration, problem-solving skills, reflexes, balance, and coordination. These exercises involve performing multiple complex tasks that require active and continuous thinking during movements. The investigators hypothesize that the complex tasks involved in these exercises may positively influence reaction time, joint position sense, proprioceptive strength, and balance, which are impaired following ACL reconstruction.
A review of the literature reveals that studies examining joint position sense, neurocognitive control, and reaction time in patients undergoing ACL reconstruction are limited. Furthermore, research investigating lower extremity reaction or detection time, resulting from disrupted somatosensory inputs after ACL injuries, is also scarce. While studies have been conducted on neuromuscular exercises in ACL rehabilitation programs, no research has been identified focusing on cognitive-based neuromuscular exercises. The lack of a gold standard rehabilitation method for ACL reconstruction in the literature has driven ongoing research into new treatment modalities and their effects. Recently, cognitive-based neuromuscular exercises have emerged as a promising method to enhance cognitive abilities, joint position sense, perceptual strength, and balance.
This study is designed to investigate the effects of cognitive-based neuromuscular exercises on reaction time, joint position sense, proprioceptive force sense, and balance disorders observed in patients following anterior cruciate ligament (ACL) reconstruction. With the results obtained from this study, the investigators aim to provide a new perspective on rehabilitation approaches in ACL reconstruction, where no gold standard treatment exists, and contribute to the literature with objective and evidence-based data regarding the effects of cognitive-based neuromuscular exercises on sensorimotor, neuromuscular, and proprioceptive senses.
Study Population and Sample The study will include individuals of both genders aged 20-40 years. Post-surgical patients will initially undergo an 8-week home-based rehabilitation program, as described by McNeil et al., with weekly monitoring to assess their progress. At the end of the 8th week, patients who meet the criteria for the early phase of a criterion-based rehabilitation approach will be included in the study. These participants will then follow an 8-week rehabilitation program, twice per week, adhering to the mid-phase criterion-based rehabilitation protocol. All rehabilitation sessions will be conducted in-person under the supervision of an experienced physiotherapist. Measurements will be performed before the rehabilitation and at the end of the 8-week program. The sample size was calculated using G*Power 3.1, and a total of 27 participants were determined with 80% power.
Data Collection Tools Demographic data, including age, gender, body weight, height, BMI, alcohol and smoking habits, injured limb, time between injury and surgery, and occupation, will be collected.
Pain Measurement: Pain intensity will be assessed using the Numeric Pain Scale (0 = no pain, 10 = worst imaginable pain).
Lower Extremity Reaction Time Measurement: FITLIGHT Corp, a wireless light-sensor system, will be used to measure reaction time. Participants will deactivate randomly lit sensors using the affected and unaffected lower extremities. Task variations will include cognitive dual tasks (e.g., counting backward by fives) and motor dual tasks (e.g., tossing and catching a ball) to assess dual-task performance.
Joint Position Sense: Passive joint position sense will be evaluated using a joint repositioning task at 15° and 45° knee flexion, with measurements taken using the "Clinometer" smartphone application. Cognitive and motor tasks will also be incorporated.
Proprioceptive Force Sense: Proprioceptive force sense will be assessed using the StabilizerTM biofeedback device. Participants will perform isometric contractions, and differences between targeted and actual force values will be recorded. Cognitive and motor dual tasks will also be included.
Static Balance Test: Single-leg stance tests will evaluate static balance under open-eye conditions. Dual-task conditions will include verbal tasks (e.g., naming words starting with specific letters) and motor tasks (e.g., holding a tray with a cup of water).
Activity Level: Pre-injury activity levels will be measured using the Tegner Activity Scale, which scores activity from 0 (no activity) to 10 (elite-level competition).
IKDC Subjective Knee Form: Knee symptoms, function, and activity levels will be evaluated using the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form. The total score ranges from 0 to 100, with higher scores indicating better function.
Treatment Protocol
Participants meeting progression criteria will undergo an 8-week mid-phase rehabilitation program (twice weekly). Patients will be randomly assigned to two groups:
Group 1: Exercises performed without secondary tasks. Group 2: Exercises performed with cognitive or motor dual tasks (e.g., rhythmic counting, reverse spelling, ball manipulation).
Example Exercises (Weeks 8-16):
Quadriceps and hamstring strengthening exercises, Hip, lumbo-pelvic, and gastrocnemius-soleus strengthening, Closed kinetic chain exercises, Functional exercises (e.g., squats, lunges, leg press), Balance training (e.g., tandem walking, single-leg stance with open and closed eyes).
Exercises will include 8-12 repetitions across 3 sets, ensuring optimal loading without over-stressing healing tissues. Pain and swelling will be closely monitored, with exercise intensity adjusted as necessary. Resistance will start at 40-50% of the unaffected limb's capacity and progress to 70-80%, depending on the patient's functional status.
- Conditions
- ACL - Anterior Cruciate Ligament Rupture
- Being tested
- Exercise
- Keywords
- ACL rupture, Cocnitive task, Proprioception, Dual Task
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called dual task exercises, cognitive exercises
During the exercises based on the protocol developed by the Royal Dutch Society for Physical Therapy (KNGF) following anterior cruciate ligament (ACL) surgery, additional cognitive tasks will be assigned to the patients.
ExerciseOther
Also called exercises
The protocol developed by the Royal Dutch Society for Physical Therapy (KNGF) will be applied following anterior cruciate ligament (ACL) surgery.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment group | Sham comparator | The protocol developed by the Royal Dutch Society for Physical Therapy (KNGF) will be applied following anterior cruciate ligament (ACL) surgery. Receives: Other: Exercise |
| experimental group | Experimental | During the exercises based on the protocol developed by the Royal Dutch Society for Physical Therapy (KNGF) following anterior cruciate ligament (ACL) surgery, additional cognitive tasks will be assigned to the patients. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of an 8-Week Cognitive-Based Neuromuscular Exercise Program on Lower Extremity Reaction Time
This study evaluates lower extremity reaction time in individuals with anterior cruciate ligament (ACL) injuries using the FITLIGHT Corp system. Participants will deactivate randomly illuminated lights with their lower extremities. The system's wireless sensor discs will be placed according to each participant's leg length to minimize balance-related factors. Five lights will be arranged in a semicircular pattern at 45-degree intervals.
Reaction time will be measured under three conditions: baseline, cognitive task, and motor task. In the baseline condition, participants will complete a 30-second practice trial followed by a 1-minute test trial. During the cognitive task, participants will count backward from 600 by fives while deactivating the lights. In the motor task, they will toss and catch a ball with their dominant hand while performing the light-deactivation task. The average reaction time in seconds will be recorded for both the injured and uninjured limbs.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start20 Jun 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ACL - Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ertuğrul Demirdel
- Sponsor type
- University, hospital or other
- Collaborators
- Antalya Bilim University
- Responsible party
- Sponsor-investigator, Ertuğrul Demirdel, Ankara Yildirim Beyazıt University
- Investigators
- Ertugrul Demirdel, Associate professor, Study director, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755398
- Sponsor's protocol ID
- AnkaraYBU-OA
- Status last verified
- Jun 2024
- First submitted
- 18 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Under the Personal Data Protection Law, disclosing personal data outside of official authorities constitutes a criminal offense. Additionally, the results of the study do not involve personal information.
Publications
Elabd OM, Elabd AM. Functional outcomes of a criterion-based rehabilitation protocol for anterior cruciate ligament reconstruction in amateur athletes: A randomised clinical trial. J Bodyw Mov Ther. 2023 Jul;35:7-13. doi: 10.1016/j.jbmt.2023.04.037. Epub 2023 Apr 17.
PubMed 37330806Buckthorpe M, Della Villa F. Optimising the 'Mid-Stage' Training and Testing Process After ACL Reconstruction. Sports Med. 2020 Apr;50(4):657-678. doi: 10.1007/s40279-019-01222-6.
PubMed 31782065Elabd OM, Alghadir AH, Ibrahim AR, Hasan S, Rizvi MR, Sharma A, Iqbal A, Elabd AM. Functional outcomes of accelerated rehabilitation protocol for anterior cruciate ligament reconstruction in amateur athletes: a randomized clinical trial. J Rehabil Med. 2024 Feb 22;56:jrm12296. doi: 10.2340/jrm.v56.12296.
PubMed 38385715Li D, Zhang Q, Liu X, Chen C, Lu J, Ye D, Li Y, Wang W, Shen M. Effect of water-based walking exercise on rehabilitation of patients following ACL reconstruction: a prospective, randomised, single-blind clinical trial. Physiotherapy. 2022 Jun;115:18-26. doi: 10.1016/j.physio.2021.11.003. Epub 2021 Dec 1.
PubMed 35101723Kiele D, Solianik R. Four-Week Application of Kinesiotaping Improves Proprioception, Strength, and Balance in Individuals With Complete Anterior Cruciate Ligament Rupture. J Strength Cond Res. 2023 Jan 1;37(1):213-219. doi: 10.1519/JSC.0000000000004245. Epub 2022 Apr 13.
PubMed 35438677Buckthorpe M, Gokeler A, Herrington L, Hughes M, Grassi A, Wadey R, Patterson S, Compagnin A, La Rosa G, Della Villa F. Optimising the Early-Stage Rehabilitation Process Post-ACL Reconstruction. Sports Med. 2024 Jan;54(1):49-72. doi: 10.1007/s40279-023-01934-w. Epub 2023 Oct 3.
PubMed 37787846Leal J, Mirza B, Davies L, Fletcher H, Stokes J, Cook JA, Price A, Beard DJ. Cost-effectiveness analysis of a pragmatic randomized trial evaluating surgical reconstruction versus rehabilitation in patients with long-standing anterior cruciate ligament injury. Bone Joint J. 2024 Jan 1;106-B(1):38-45. doi: 10.1302/0301-620X.106B1.BJJ-2023-0175.R1.
PubMed 38160685Akbasli O, Demirdel E. Effects of Cognitive and Motor Dual-Task Conditions on Reaction Time, Proprioception, and Proprioceptive Force Sense in Individuals After Anterior Cruciate Ligament Reconstruction: A Pilot Study. Physiother Res Int. 2026 Jul;31(3):e70294. doi: 10.1002/pri.70294.
PubMed 42458927
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cognitive-Based Neuromuscular Exercises on Reaction Time, Joint Position Sense, Proprioceptive Force Sense and Balance in Individuals Who Had Anterior Cruciate Ligament Surgery
- ClinicalTrials.gov ID
- NCT06755398
- Acronym / sponsor ID
- AnkaraYBU-OA
- Conditions
- ACL - Anterior Cruciate Ligament Rupture
- Keywords
- ACL rupture, Cocnitive task, Proprioception, Dual Task
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Ertuğrul DemirdelUniversity, hospital or other
- Collaborators
- Antalya Bilim University
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the effects of cognitive-based neuromuscular exercises on increased reaction time, decreased joint position sense, reduced proprioceptive force sense, and balance problems in individuals who have undergone surgery following anterior cruciate ligament (ACL) injuries. With the results obtained from the study, the investigators aim to provide a different perspective on rehabilitation methods applied after ACL reconstruction and contribute to the literature with objective and evidence-based information regarding the effects of cognitive-based neuromuscular exercises on sensorimotor, neuromuscular, and proprioceptive senses.
Detailed description
Anterior Cruciate Ligament (ACL) injuries are among the most common knee injuries, occurring due to both contact and non-contact mechanisms, such as sudden deceleration, changes in direction, or landing after jumping, and leading to disruptions in knee stability and biomechanics. In the United States, it is estimated that there are between 100,000 and 200,000 cases annually, while the global incidence of ACL ruptures approaches 2 million cases per year. Treatment for ACL injuries can be either conservative or surgical. Conservative treatment is considered a viable option for specific populations, such as athletes who do not engage in activities requiring direction changes, individuals with no significant knee instability, and those with lower activity levels. ACL injuries result in quadriceps and hamstring weakness, reduced knee joint proprioception, and impaired balance.
To restore the anatomy and biomechanics of the knee, arthroscopic ACL reconstruction is performed to stabilize the knee and prevent secondary injuries, with approximately 30,000 procedures conducted annually in the United Kingdom. Although comprehensive rehabilitation is a critical component of ACL injury management, whether treated conservatively or surgically, there is currently no gold standard rehabilitation approach for such a widespread injury.
The type of rehabilitation protocol applied is one of the most significant factors influencing the outcomes of ACL reconstruction. Rehabilitation protocols have evolved substantially over the past few decades, with traditional rehabilitation, accelerated rehabilitation, and criterion-based rehabilitation protocols being the most commonly employed. These protocols aim to enhance muscle strength, improve proprioception, and ensure knee stabilization, with the timing and types of exercises determined by the biological healing and remodeling periods of the graft.
Criterion-based rehabilitation protocols, a relatively new approach, aim to provide patient-specific rehabilitation and maximize progress. Developed in 2016 by the Royal Dutch Society for Physical Therapy (KNGF), this protocol is divided into three phases: early, mid, and late stages. To progress to the next stage, patients must meet specific goals for each phase, which are verified through objective and subjective testing. The effectiveness and quality of early and mid-stage rehabilitation significantly influence long-term outcomes. The goals of early-stage rehabilitation, lasting approximately two months, include reducing effusion, restoring joint range of motion, and minimizing muscle atrophy. During the mid-stage, which extends from the second to the sixth month, the focus shifts to achieving full control of knee extension, restoring 80% of the muscle strength in the operated limb compared to the uninjured side, and regaining jumping ability. This phase includes exercises such as knee flexor and extensor strengthening, closed kinetic chain exercises, functional exercises, balance training, plyometric exercises, and neuromuscular exercises.
Neuromuscular control is essential for initiating movement and requires the integration of sensory information from proprioceptive, kinesthetic, visual, and vestibular sources, as well as cortical and spinal motor commands. This control is critical for the effective execution of movement. Recent studies indicate that ACL injuries are not isolated joint damages that merely affect stability and biomechanics but also directly influence neuromuscular control of the knee via mechanoreceptors located within the ACL. These injuries lead to neurophysiological effects on sensorimotor control. Following ACL injuries, these somatosensory changes may result in deficits in postural and motor control, leading to slower lower extremity reaction times. Additionally, nociceptive activity related to pain and swelling, combined with reduced joint position sense and kinesthesia, impairs movement quality. Neuromuscular control impairments, proprioceptive deficits, and disruptions in somatosensory inputs due to damaged mechanoreceptors may persist for 9-12 months, highlighting the need for targeted exercises during the mid-stage rehabilitation.
The complex integration of vestibular, visual, and somatosensory inputs, necessary for situational awareness, enhanced alertness, and the ability to select between attentional resources, can promote the development of neurocognitive functions. Cognitive-based neuromuscular exercises aim to improve patients' reaction times, joint position sense, proprioceptive strength, and neurocognitive functions such as balance, while enhancing motor control and knee stability. An example of cognitive-based neuromuscular exercises is the Life Kinetik (LK) method, developed by Lutz in Germany in 2007. This method is used to promote neural learning, support neuroplasticity, and reduce neurological symptoms. During these exercises, visual or cognitive tasks are combined with physical activity to train the brain, aiming to enhance concentration, problem-solving skills, reflexes, balance, and coordination. These exercises involve performing multiple complex tasks that require active and continuous thinking during movements. The investigators hypothesize that the complex tasks involved in these exercises may positively influence reaction time, joint position sense, proprioceptive strength, and balance, which are impaired following ACL reconstruction.
A review of the literature reveals that studies examining joint position sense, neurocognitive control, and reaction time in patients undergoing ACL reconstruction are limited. Furthermore, research investigating lower extremity reaction or detection time, resulting from disrupted somatosensory inputs after ACL injuries, is also scarce. While studies have been conducted on neuromuscular exercises in ACL rehabilitation programs, no research has been identified focusing on cognitive-based neuromuscular exercises. The lack of a gold standard rehabilitation method for ACL reconstruction in the literature has driven ongoing research into new treatment modalities and their effects. Recently, cognitive-based neuromuscular exercises have emerged as a promising method to enhance cognitive abilities, joint position sense, perceptual strength, and balance.
This study is designed to investigate the effects of cognitive-based neuromuscular exercises on reaction time, joint position sense, proprioceptive force sense, and balance disorders observed in patients following anterior cruciate ligament (ACL) reconstruction. With the results obtained from this study, the investigators aim to provide a new perspective on rehabilitation approaches in ACL reconstruction, where no gold standard treatment exists, and contribute to the literature with objective and evidence-based data regarding the effects of cognitive-based neuromuscular exercises on sensorimotor, neuromuscular, and proprioceptive senses.
Study Population and Sample The study will include individuals of both genders aged 20-40 years. Post-surgical patients will initially undergo an 8-week home-based rehabilitation program, as described by McNeil et al., with weekly monitoring to assess their progress. At the end of the 8th week, patients who meet the criteria for the early phase of a criterion-based rehabilitation approach will be included in the study. These participants will then follow an 8-week rehabilitation program, twice per week, adhering to the mid-phase criterion-based rehabilitation protocol. All rehabilitation sessions will be conducted in-person under the supervision of an experienced physiotherapist. Measurements will be performed before the rehabilitation and at the end of the 8-week program. The sample size was calculated using G*Power 3.1, and a total of 27 participants were determined with 80% power.
Data Collection Tools Demographic data, including age, gender, body weight, height, BMI, alcohol and smoking habits, injured limb, time between injury and surgery, and occupation, will be collected.
Pain Measurement: Pain intensity will be assessed using the Numeric Pain Scale (0 = no pain, 10 = worst imaginable pain).
Lower Extremity Reaction Time Measurement: FITLIGHT Corp, a wireless light-sensor system, will be used to measure reaction time. Participants will deactivate randomly lit sensors using the affected and unaffected lower extremities. Task variations will include cognitive dual tasks (e.g., counting backward by fives) and motor dual tasks (e.g., tossing and catching a ball) to assess dual-task performance.
Joint Position Sense: Passive joint position sense will be evaluated using a joint repositioning task at 15° and 45° knee flexion, with measurements taken using the "Clinometer" smartphone application. Cognitive and motor tasks will also be incorporated.
Proprioceptive Force Sense: Proprioceptive force sense will be assessed using the StabilizerTM biofeedback device. Participants will perform isometric contractions, and differences between targeted and actual force values will be recorded. Cognitive and motor dual tasks will also be included.
Static Balance Test: Single-leg stance tests will evaluate static balance under open-eye conditions. Dual-task conditions will include verbal tasks (e.g., naming words starting with specific letters) and motor tasks (e.g., holding a tray with a cup of water).
Activity Level: Pre-injury activity levels will be measured using the Tegner Activity Scale, which scores activity from 0 (no activity) to 10 (elite-level competition).
IKDC Subjective Knee Form: Knee symptoms, function, and activity levels will be evaluated using the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form. The total score ranges from 0 to 100, with higher scores indicating better function.
Treatment Protocol
Participants meeting progression criteria will undergo an 8-week mid-phase rehabilitation program (twice weekly). Patients will be randomly assigned to two groups:
Group 1: Exercises performed without secondary tasks. Group 2: Exercises performed with cognitive or motor dual tasks (e.g., rhythmic counting, reverse spelling, ball manipulation).
Example Exercises (Weeks 8-16):
Quadriceps and hamstring strengthening exercises, Hip, lumbo-pelvic, and gastrocnemius-soleus strengthening, Closed kinetic chain exercises, Functional exercises (e.g., squats, lunges, leg press), Balance training (e.g., tandem walking, single-leg stance with open and closed eyes).
Exercises will include 8-12 repetitions across 3 sets, ensuring optimal loading without over-stressing healing tissues. Pain and swelling will be closely monitored, with exercise intensity adjusted as necessary. Resistance will start at 40-50% of the unaffected limb's capacity and progress to 70-80%, depending on the patient's functional status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment group | Sham comparator | Other: ExerciseThe protocol developed by the Royal Dutch Society for Physical Therapy (KNGF) will be applied following anterior cruciate ligament (ACL) surgery. |
| experimental group | Experimental | Other: ExerciseDuring the exercises based on the protocol developed by the Royal Dutch Society for Physical Therapy (KNGF) following anterior cruciate ligament (ACL) surgery, additional cognitive tasks will be assigned to the patients. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Having sustained a unilateral isolated anterior cruciate ligament injury,
- Having undergone anterior cruciate ligament reconstruction using a hamstring graft by a surgeon at least 8 weeks ago,
- Having completed the early phase of the postoperative criterion-based rehabilitation protocol and met the criteria for progression to the intermediate phase of the rehabilitation program (1- pain between 0-2 on the numeric pain scale, 2- no effusion in the knee, 3- no limitation in passive knee extension, 4- passive knee flexion of at least 120°, 5- full quadriceps activation (patient able to perform 10 repetitions of a single-leg raise exercise), and 6- normalized gait pattern without assistance).
Key exclusion criteria (6 listed)
- Having a partial ACL tear,
- Having sustained bilateral ACL injuries,
- Having additional injuries accompanying the ACL injury,
- Having undergone ACL revision surgery,
- Having a history of complex knee surgery,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: dual task exercises, cognitive exercisesDuring the exercises based on the protocol developed by the Royal Dutch Society for Physical Therapy (KNGF) following anterior cruciate ligament (ACL) surgery, additional cognitive tasks will be assigned to the patients. | Other | Standard treatment group |
| ExerciseAlso: exercisesThe protocol developed by the Royal Dutch Society for Physical Therapy (KNGF) will be applied following anterior cruciate ligament (ACL) surgery. | Other | experimental group |
Primary outcome
The Effect of an 8-Week Cognitive-Based Neuromuscular Exercise Program on Lower Extremity Reaction Time
Time frame: 8 week
This study evaluates lower extremity reaction time in individuals with anterior cruciate ligament (ACL) injuries using the FITLIGHT Corp system. Participants will deactivate randomly illuminated lights with their lower extremities. The system's wireless sensor discs will be placed according to each participant's leg length to minimize balance-related factors. Five lights will be arranged in a semicircular pattern at 45-degree intervals. Reaction time will be measured under three conditions: baseline, cognitive task, and motor task. In the baseline condition, participants will complete a 30-second practice trial followed by a 1-minute test trial. During the cognitive task, participants will count backward from 600 by fives while deactivating the lights. In the motor task, they will toss and catch a ball with their dominant hand while performing the light-deactivation task. The average reaction time in seconds will be recorded for both the injured and uninjured limbs.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Background: PubMed 37330806Elabd OM, Elabd AM. Functional outcomes of a criterion-based rehabilitation protocol for anterior cruciate ligament reconstruction in amateur athletes: A randomised clinical trial. J Bodyw Mov Ther. 2023 Jul;35:7-13. doi: 10.1016/j.jbmt.2023.04.037. Epub 2023 Apr 17.
- Background: PubMed 31782065Buckthorpe M, Della Villa F. Optimising the 'Mid-Stage' Training and Testing Process After ACL Reconstruction. Sports Med. 2020 Apr;50(4):657-678. doi: 10.1007/s40279-019-01222-6.
- Background: PubMed 38385715Elabd OM, Alghadir AH, Ibrahim AR, Hasan S, Rizvi MR, Sharma A, Iqbal A, Elabd AM. Functional outcomes of accelerated rehabilitation protocol for anterior cruciate ligament reconstruction in amateur athletes: a randomized clinical trial. J Rehabil Med. 2024 Feb 22;56:jrm12296. doi: 10.2340/jrm.v56.12296.
- Background: PubMed 35101723Li D, Zhang Q, Liu X, Chen C, Lu J, Ye D, Li Y, Wang W, Shen M. Effect of water-based walking exercise on rehabilitation of patients following ACL reconstruction: a prospective, randomised, single-blind clinical trial. Physiotherapy. 2022 Jun;115:18-26. doi: 10.1016/j.physio.2021.11.003. Epub 2021 Dec 1.
- Background: PubMed 35438677Kiele D, Solianik R. Four-Week Application of Kinesiotaping Improves Proprioception, Strength, and Balance in Individuals With Complete Anterior Cruciate Ligament Rupture. J Strength Cond Res. 2023 Jan 1;37(1):213-219. doi: 10.1519/JSC.0000000000004245. Epub 2022 Apr 13.
- Background: PubMed 37787846Buckthorpe M, Gokeler A, Herrington L, Hughes M, Grassi A, Wadey R, Patterson S, Compagnin A, La Rosa G, Della Villa F. Optimising the Early-Stage Rehabilitation Process Post-ACL Reconstruction. Sports Med. 2024 Jan;54(1):49-72. doi: 10.1007/s40279-023-01934-w. Epub 2023 Oct 3.
- Background: PubMed 38160685Leal J, Mirza B, Davies L, Fletcher H, Stokes J, Cook JA, Price A, Beard DJ. Cost-effectiveness analysis of a pragmatic randomized trial evaluating surgical reconstruction versus rehabilitation in patients with long-standing anterior cruciate ligament injury. Bone Joint J. 2024 Jan 1;106-B(1):38-45. doi: 10.1302/0301-620X.106B1.BJJ-2023-0175.R1.
- Derived from this study: PubMed 42458927Akbasli O, Demirdel E. Effects of Cognitive and Motor Dual-Task Conditions on Reaction Time, Proprioception, and Proprioceptive Force Sense in Individuals After Anterior Cruciate Ligament Reconstruction: A Pilot Study. Physiother Res Int. 2026 Jul;31(3):e70294. doi: 10.1002/pri.70294.
- Individual participant dataSharing planned: No. Under the Personal Data Protection Law, disclosing personal data outside of official authorities constitutes a criminal offense. Additionally, the results of the study do not involve personal information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ertugrul Demirdel, Associate professor study director
Ankara Yildirim Beyazıt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with ACL - Anterior Cruciate Ligament Rupture, run by Ertuğrul Demirdel at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Effect of an 8-Week Cognitive-Based Neuromuscular Exercise Program on Lower Extremity Reaction Time (time frame: 8 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06755398, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2025.