CTRI

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CTRI Number

CTRI/2025/05/087599 [Registered on: 26/05/2025] Trial Registered Prospectively

Last Modified On:

26/05/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Physiotherapy (Not Including YOGA)

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Effect of Cognitive and Proprioceptive Training on Postural sway in ACL Reconstruction Patients.

Scientific Title of Study

Effect of Cognitive Training along with Proprioceptive Training on Postural Sway in Patients after Anterior Cruciate Ligament Reconstruction Surgery.

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Premkumari Ganesan
Designation	PHD Scholar
Affiliation	Saveetha College of Physiotherapy
Address	Department Of Physiotherapy Division: Physiotherapy Room NO:5C3 Saveetha Nagar Thandalam-602105 Chennai TAMIL NADU 602105 India
Phone	7094641279
Fax
Email	gpremkumari@yahoo.in

Details of Contact Person
Scientific Query

Name	S.Senthilkumar
Designation	Associate Professor
Affiliation	Saveetha College of Physiotherapy
Address	Department of Physiotherapy, Room no :5B3 Division: Physiotherapy Saveetha Nagar Thandalam-602105 Chennai TAMIL NADU 602105 India
Phone	9840784295
Fax
Email	senthilkumar.scpt@saveetha.com

Details of Contact Person
Public Query

Name	Dharani.P
Designation	Secretary
Affiliation	SAVEETHA COLLEGE OF PHYSIOTHERAPY
Address	Department of Physiotherapy Room No: E4 Division: Physiotherapy saveetha nagar Thandalam-602105 Chennai TAMIL NADU 602001 India
Phone	9941318923
Fax
Email	dharani.j18@gmail.com

Source of Monetary or Material Support

Saveetha College of Medical and Technical Sciences, Saveetha College of Physiotherapy, Saveetha Nagar, Thandalam Chennai-602105, Tamilnadu India

Primary Sponsor

Name	Saveetha college of Medical and Technical sciences
Address	Saveetha College of Physiotherapy, Saveetha Nagar, Thandalam-602105 Chennai, Tamilnadu
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
DrSSenthilkumar	SAVEETHA COLLEGE OF MEDICAL AND TECHNICAL SCIENCES	Saveetha College of Physiotherapy, Department of General and Hand Surgical Physiotherapy, Room no: 5B3 ,(Physiotherapy and Orthopaedic) Saveetha Nagar, Thandalam-602105 Chennai TAMIL NADU	9840784295 senthilkumar.scpt@saveetha.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
SMCH-IEC	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: M708\|\|Other soft tissue disorders related to use, overuse and pressure,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Cognitive Training Along with Proprioceptive Training Compared with Conventional ACL Protocol	Group A: Cognitive and Proprioceptive Training Group This group participates in a six-week program combining cognitive, proprioceptive, and mindfulness training to improve neuromuscular control and cognitive function after ACL reconstruction. The goal is a holistic recovery that enhances physical stability and brain functions linked to movement and decision-making. Weeks 1–2 (Foundational Phase) Patients perform basic proprioceptive exercises like single-leg stances on unstable surfaces and joint position sense drills. Cognitive tasks such as counting backwards and memory recall are paired with balance exercises to train dual-tasking. Mindfulness techniques like body scans and deep breathing promote relaxation and body awareness. Weeks 3–4 (Intermediate Phase) Exercises progress to dynamic balance and reactive movements, combined with problem-solving and rapid decision-making tasks. Mindful movement encourages body awareness and emotional regulation. Weeks 5–6 (Advanced Phase) High-intensity drills, including jump landings and cutting manoeuvres, are added alongside fast cognitive challenges involving reaction time and problem-solving. Mindfulness supports stress management during these demanding activities. Group B: Conventional ACL Rehabilitation Group This group follows a traditional six-week rehabilitation focusing on physical recovery without cognitive or mindfulness elements. It includes inflammation control, range of motion restoration, strengthening, and sport-specific drills preparing patients for return to activity.
Intervention	Cognitive Training along with Proprioceptive Training in Post ACL Reconstruction Surgery	This 6-week intervention, with 4 sessions per week, combines Cognitive and Proprioceptive training to enhance recovery post-ACL reconstruction. In the first two weeks, the focus is on basic proprioceptive exercises, such as single-leg stances and balance on unstable surfaces, while simple cognitive tasks like counting or memory recall are introduced during these activities. Mindfulness techniques, such as body scan meditation and breathing exercises, are also introduced to promote relaxation and body awareness. In weeks 3 and 4, the exercises become more dynamic, with reactive training and dual-tasking, such as solving problems or recalling sequences while balancing. Visual-motor tasks are also added to improve cognitive-motor integration, and mindfulness expands to encourage focused attention and mindful movement during exercises. In the final two weeks, the program progresses to more advanced proprioceptive tasks like jump landings, cutting drills, and sport-specific movements, while cognitive tasks increase in complexity, including decision-making drills and reaction-based exercises. Mindfulness continues to focus on mindful movement and breathing techniques to enhance concentration and manage stress. This integrated approach aims to optimise physical and cognitive recovery, ensuring a holistic and effective rehabilitation process.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	40.00 Year(s)
Gender	Both
Details	Subjects with Unilateral Post ACLR Both Gender Age 18-40 Years

ExclusionCriteria

Details

ANY DEFORMITY IN THE KNEE JOINT
BILATERAL KNEE INJURY, ASSOCIATED LIGAMENT INJURY -UNHAPPY TRIAD
SUBJECTS WITH VESTIBULAR DYSFUNCTION

Method of Generating Random Sequence

Stratified randomization

Method of Concealment

An Open list of random numbers

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
International Knee Documentation Committee (IKDC)-Functional activities Lord’s Sway Meter-Postural Sway	1st Week 3rd Week 6th Week

Secondary Outcome

Outcome	TimePoints
Visual analogue scale-Pain Goniometer-Range of motion Cognitive & Affective Mindfulness Scale-Revised (CAMS-R)-Cognitive level	1st WEEK 3rd WEEK 6th WEEK

Target Sample Size

Total Sample Size="60"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

06/06/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="6"
Days="10"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

The Anterior Cruciate Ligament (ACL) is one of the major stabilizing ligaments of the knee, playing a crucial role in maintaining joint integrity during movement. ACL injuries are common, particularly among athletes, and often result from sudden stops, changes in direction, or direct trauma. When the ACL is torn, it leads to knee instability, pain, and reduced functional ability, often requiring surgical reconstruction to restore normal joint function.

ACLR is a surgical procedure where the damaged ACL is replaced with a graft, typically from the patellar tendon, hamstring tendon, or quadriceps tendon. Post-surgery, patients often experience proprioceptive deficits, postural instability, muscle weakness, and altered neuromuscular control, which can lead to difficulties in returning to pre-injury activity levels.

The clinical features of ACL injury include knee pain, swelling, instability, loss of motion, and difficulty in weight-bearing activities. Additionally, post-ACLR rehabilitation is crucial to regain strength, balance, proprioception, and neuromuscular control to prevent future injuries and complications such as osteoarthritis.

Current rehabilitation interventions for ACL reconstruction involve a combination of physical therapy, proprioceptive training, and neuromuscular re-education. Studies indicate that Cognitive Training and Proprioceptive Training are effective in reducing postural sway, improving balance, and enhancing knee stability post-ACLR.

This study aims to examine the effects of Cognitive Training and Proprioceptive Training on postural control, balance, and functional recovery in individuals after ACL reconstruction. By incorporating targeted rehabilitation strategies, this research seeks to improve long-term functional outcomes and aid in the safe return to sports and daily activities.