- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07642752
Perturbation Training vs Functional Activities on Pain, ROM, Balance, and Function Post-ACL
Effects of Perturbation Training Versus Task-oriented Functional Activities on Pain, Range of Motion, Balance and Function in Post-anterior Cruciate Ligament Reconstruction
Study Overview
Status
Conditions
Detailed Description
This randomized controlled trial aims to compare the effectiveness of perturbation training and task-oriented functional activities in patients following ACL reconstruction surgery. Perturbation training is a neuromuscular re-education strategy that involves controlled, unexpected movements to enhance joint stability and proprioceptive feedback. In contrast, task-oriented functional training focuses on restoring movement through activities that mimic daily or sports-related functional tasks.
This study will be a Randomized Control Trail and will be conducted in physiogic physiotherapy clinic and Ghurki Trust and Teaching Hospital. Non-Probability Convenient Sampling will be used to collect data. Total of 54 Participants of the age 18-45 years with post 12 weeks to 1 year ACL reconstruction will be included in the study. An informed consent will be taken prior study from all the subjects. Outcomes measure will be included Numerical Pain Rating Scale (NPRS) for pain, Universal Goniometer (UG) for Range of Motion, Y balance test for Knee Stability, International Knee Documentation Committee scores, (IKDC) for Knee function
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, PhD
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: Hira Butt
- Phone Number: 03360405480
- Email: hirabutt7582@gmail.com
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Ghurki Hospital Lahore
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Principal Investigator:
- Muhammad Musab, MSOMPT
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age range: 18-45 years
Male participants only
History of Anterior Cruciate Ligament Reconstruction (ACLR) of 3 to 12 months
No prior ACL surgery on the affected knee
ACL reconstruction with autograft of hamstrings tendon
Knee flexion range of motion less than 120°
Extension lag less than or equal to 10°
Pain during functional activities
Exclusion Criteria:
- Any type of fracture
Concurrent ligamentous injury or repairable meniscus
Osteochondral defect
Any systemic and/or neurological illness
Rheumatoid arthritis
Osteomyelitis or any neurological disorders
Spinal disorders
Inflammatory conditions such as ankylosing spondylitis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Perturbation Training Group
Participants undergo perturbation-based exercises designed to improve knee stability.
It includes balance boards, BOSU balls, and manual perturbation techniques.
|
Two-leg rocker board One-leg rocker board Roller board / stable (weight scale) surface Roller board / BOSU ball TheraBand feedback / perturbation training Simple sport-specific technique on rocker board Moderate demand sport-specific technique on rocker board Advanced sport-specific technique on rocker board This sequence reflects a progressive challenge to knee stability, beginning with bilateral balance tasks, advancing to unilateral control, and culminating in sport-specific perturbation drills. Heating pad (5-10 minutes) TENS (short bursts, 10-15 minutes, frequency 100 Hz) Stationary cycling Gentle range of motion exercises Passive and active-assisted ROM Isometric quadriceps contractions Straight leg raises Quadriceps setting with a towel under the knee Closed-chain exercises (e.g., wall sits, mini-squats) Hamstring curls Double-leg stance on foam pad This set emphasizes pain relief, mobility restoration, and foundational strength before progressing to advanced neuromuscular or sport-specific tasks. |
|
Active Comparator: Task-Oriented Functional Activities Group
Participants engage in functional movement exercises that mimic daily activities.
It includes step training, agility drills, and controlled landing mechanics.
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Heating pad (5-10 minutes) TENS (short bursts, 10-15 minutes, frequency 100 Hz) Stationary cycling Gentle range of motion exercises Passive and active-assisted ROM Isometric quadriceps contractions Straight leg raises Quadriceps setting with a towel under the knee Closed-chain exercises (e.g., wall sits, mini-squats) Hamstring curls Double-leg stance on foam pad This set emphasizes pain relief, mobility restoration, and foundational strength before progressing to advanced neuromuscular or sport-specific tasks. Functional Recovery Tasks After ACLR Normal walking gait Bilateral squat Unilateral foundation exercises - Single leg squat Bilateral landing Running - Run on treadmill Bilateral plyometric - Bilateral drop jump Unilateral landing / deceleration - Single leg deceleration Unilateral plyometric - Single leg drop jump Change of direction ability / coordination - 90º cut maneuver Sport-specific movements - Movement control under sport-specific change of direction This sequence reflects a progressive load and skill development pathway, starting from basic gait and bilateral tasks, moving toward unilateral control, plyometrics, and finally sport-specific agility. |
|
Sham Comparator: Control Group (Standard Rehabilitation Protocol)
Participants follow traditional ACL rehabilitation without perturbation or task-oriented interventions.
It includes strength training, range-of-motion exercises, and proprioceptive drills.
|
Heating pad (5-10 minutes) TENS (short bursts, 10-15 minutes, frequency 100 Hz) Stationary cycling Gentle range of motion exercises Passive and active-assisted ROM Isometric quadriceps contractions Straight leg raises Quadriceps setting with a towel under the knee Closed-chain exercises (e.g., wall sits, mini-squats) Hamstring curls Double-leg stance on foam pad This set emphasizes pain relief, mobility restoration, and foundational strength before progressing to advanced neuromuscular or sport-specific tasks. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NPRS for Pain
Time Frame: 6 weeks
|
Numeric Pain Rating Scale (NPRS) it is a unidimensional scale to measure pain intensity, particularly in adults.
It is a 10-rating scale and an 11-point numeric scale in the form of a horizontal bar or line
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6 weeks
|
|
Universal Goniometer for Range of motion
Time Frame: 6 weeks
|
A universal goniometer (UG) will be used to determine the range of motion of the target joint.
|
6 weeks
|
|
The Y-Balance test (YBT)
Time Frame: 6 weeks
|
The Y-Balance test (YBT) is used to assess dynamic balance impairments associated with lower extremity injuries such as ACL injury, patellofemoral pain syndrome, and ankle instability.
|
6 weeks
|
|
International Knee Documentation Committee scores (IKDC)
Time Frame: 6 weeks
|
Patients' knee function is evaluated using the International Knee Documentation Committee's (IKDC) Subjective Knee Form.
Through 18 questions, it assesses symptoms, athletic activity, and general knee function; higher scores indicate better knee function.
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hira Shaukat, Mphill, Riphah International University
Publications and helpful links
General Publications
- Carter HM, Littlewood C, Webster KE, Smith BE. The effectiveness of preoperative rehabilitation programmes on postoperative outcomes following anterior cruciate ligament (ACL) reconstruction: a systematic review. BMC Musculoskelet Disord. 2020 Oct 3;21(1):647. doi: 10.1186/s12891-020-03676-6.
- Hetsroni I, Mann G, Arami E, van Stee M, Marom N, Ohana N. Young men undergoing anterior cruciate ligament reconstruction with patellar tendon autograft and anteromedial drilling outperform at 5- to 10-year follow-up in terms of graft stability and activity levels compared to those undergoing reconstruction with hamstring autograft and transtibial drilling. J ISAKOS. 2024 Aug;9(4):540-548. doi: 10.1016/j.jisako.2024.04.001. Epub 2024 Apr 3.
- Nawasreh Z, Logerstedt D, Marmon A, Snyder-Mackler L. Clinical and Biomechanical Efficacies of Mechanical Perturbation Training After Anterior Cruciate Ligament Rupture. J Sport Rehabil. 2019 Nov 1;28(8):877-886. doi: 10.1123/jsr.2017-0363.
- Brown SR, Washabaugh EP, Dutt-Mazumder A, Wojtys EM, Palmieri-Smith RM, Krishnan C. Functional Resistance Training to Improve Knee Strength and Function After Acute Anterior Cruciate Ligament Reconstruction: A Case Study. Sports Health. 2021 Mar;13(2):136-144. doi: 10.1177/1941738120955184. Epub 2020 Dec 18.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/25/0118
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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