Protocol summary

Study aim
To examine the effects of specific quadriceps open and closed chain on knee function (pain, knee function, ROM and recurrence of ACL) after anterior cruciate ligament reconstruction surgery.
Design
Parallel group single blind randomized controlled trial
Settings and conduct
Physical Therapy Department, Northwest General Hospital & Research Center Peshawar, Pakistan and Rehman Medical Institute Peshawar, Pakistan.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age: 20-50 years, Both Gender Patients having Unilateral Anterior Cruciate Ligament reconstruction Healthy Contralateral leg ACL reconstruction surgery Ability to walk with or without an assistive device Exclusion Criteria: Any previous knee injury History of dislocation hip Concomitant injury Posterior Cruciate ligament Tear Any rheumatologic conditions Any trauma or meniscus injury History of Ligamentous instability at knee History of referred pain from the lumbar spine, hip, pelvis and sacroiliac regions Patients with history of remarkable knee joint inflammation and effusion, Patients with history of Hyperextension of knee joint Patients with history of polio paralysis Previous History of physiotherapy session for knee treatment
Intervention groups
Group-A: consisting of Controlled alternate quad and hamstring activity in open kinematic chain (OKC) plus Routine Physical Therapy Group-B: consisting of Controlled squats in closed kinematic chain (CKC) plus Routine Physical Therapy Group-C: (Combined Group) consisting of Controlled squats in closed kinematic chain (CKC) & controlled alternate quad and hamstring activity in open kinematic chain (OKC) plus Routine Physical Therapy All groups will get 60 Minute session, 3 days a week alternatively for 12 weeks
Main outcome variables
Pain Knee Function Range of Motion Recurrence of ACL

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200331046903N1
Registration date: 2020-04-21, 1399/02/02
Registration timing: registered_while_recruiting

Last update: 2020-04-21, 1399/02/02
Update count: 0
Registration date
2020-04-21, 1399/02/02
Registrant information
Name
Danish Ali Khan
Name of organization / entity
University of lahore
Country
Pakistan
Phone
+92 91 5813805
Email address
dani_ak_pk@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-15, 1399/01/27
Expected recruitment end date
2020-10-15, 1399/07/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
EFFECTS OF QUADRICEPS KINETIC EXERCISES AT SPECIFIC KNEE ANGLE IN PATIENTS WITH POST-SURGICAL ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION: A RANDOMIZED CONTROLLED TRIAL
Public title
EFFECTS OF QUADRICEPS KINETIC EXERCISES AT SPECIFIC KNEE ANGLE IN PATIENTS WITH POST-SURGICAL ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION: A RANDOMIZED CONTROLLED TRIAL
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 20-50 years Both male and female patients Patients having Unilateral Anterior Cruciate Ligament reconstruction Healthy Contralateral leg ACL reconstruction surgery Ability to walk with or without an assistive device
Exclusion criteria:
Any previous knee injury History of dislocation hip Concomitant injury Posterior Cruciate ligament Tear Any rheumatologic conditions (osteoarthritis, rheumatoid arthritis), Any trauma or meniscus injury History of Ligamentous instability at knee History of referred pain from the lumbar spine, hip, pelvis and sacroiliac regions Patients with history of remarkable knee joint inflammation and effusion, Patients with history of Hyperextension of knee joint Patients with history of polio paralysis Previous History of physiotherapy session for knee treatment
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
The subject fulfilling the inclusion criteria will be enrolled by independent outcome assessor then lottery method will be used for randomization. Each member of the population will be number systematically and in consequent manner by writing each number on a separate piece of paper. These pieces of paper are mixed and put into a box and then numbers are drawn out of the box in a random manner. The subject’s randomization method will reduce the chances of group bias allocation.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study is single blinded in which outcome assessor will be kept blind
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Institutional Review Board of University Institute of Physical therapy University of Lahore
Street address
1- Km Raiwind Rd, Sultan Town, Lahore, Punjab
City
Lahore
Postal code
54792
Approval date
2020-01-22, 1398/11/02
Ethics committee reference number
IRB-UOL-FAHS/695/2020

Health conditions studied

1

Description of health condition studied
Anterior Cruciate ligament Reconstruction
ICD-10 code
S83.519A
ICD-10 code description
Sprain of anterior cruciate ligament of unspecified knee, initial encounter

Primary outcomes

1

Description
Pain
Timepoint
before intervention and 6, 12 and 24 weeks after intervention
Method of measurement
Visual Analogue Scale

2

Description
Knee Function
Timepoint
before intervention and 6, 12 and 24 weeks after intervention
Method of measurement
Lysholm Knee Scoring scale

3

Description
Range of Motion
Timepoint
before intervention and 6, 12 and 24 weeks after intervention
Method of measurement
Goniometer

4

Description
Recurrence of Anterior Cruciate Ligament
Timepoint
before intervention and 6, 12 and 24 weeks after intervention
Method of measurement
Lachman Test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1. Patients in this study group will get 60 Minute session, 3 days a week alternatively for 12 weeks consisting of Controlled alternate quad and hamstring activity in open kinematic chain (OKC) + Routine Physical Therapy, Modalities and Exercise for other body parts including contralateral lower limb, trunk, upper limbs, respiratory exercises.
Category
Treatment - Other

2

Description
Intervention group 2. Patients in this study group will get 60 Minute session, 3 days a week alternatively for 12 weeks consisting of Controlled squats in closed kinematic chain (CKC) + Routine Physical Therapy, Modalities and Exercise for other body parts including contralateral lower limb, trunk, upper limbs, respiratory exercises.
Category
Treatment - Other

3

Description
Intervention group 3. Patients in this study group will get 60 Minute session, 3 days a week alternatively for 12 weeks consisting of Controlled squats in closed kinematic chain (CKC) & controlled alternate quad and hamstring activity in open kinematic chain (OKC) + Routine Physical Therapy, Modalities and Exercise for other body parts including contralateral lower limb, trunk, upper limbs, respiratory exercises.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Physical Therapy Department Northwest General Hospital and Research Center , Peshawar, KPK, Pakistan
Full name of responsible person
Danish Ali Khan
Street address
Passport Office Rd, Phase 5 Hayatabad, Peshawar, Khyber Pakhtunkhwa
City
Peshawar
Postal code
25100
Phone
+92 91 5838800
Email
dani_ak_pk@hotmail.com
Web page address
https://www.nwgh.pk/contact-us

2

Recruitment center
Name of recruitment center
Physical therapy Department Rehman Medical Institute Peshawar, Pakistan.
Full name of responsible person
Danish Ali Khan
Street address
Phase 5 hayatabad Peshawar Pakistan
City
Peshawar
Postal code
25100
Phone
+92 91 5838800
Email
dani_ak_pk@hotmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Lahore
Full name of responsible person
Prof Dr. Ashfaq Ahmad
Street address
1- Km Raiwind Rd, Sultan Town, Lahore, Punjab
City
Lahore
Postal code
54792
Phone
+92 42 35963424
Email
ashfaaqpt@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Lahore
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Danish Ali Khan
Position
PhD Scholar
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
1- Km Raiwind Rd, Sultan Town, Lahore, Punjab
City
Lahore
Province
Panjab
Postal code
54792
Phone
+92 42 35963424
Email
dani_ak_pk@hotmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Prof Dr Ashfaq Ahmad
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
1- Km Raiwind Rd, Sultan Town, Lahore, Punjab
City
Lahore
Province
Punjab
Postal code
54792
Phone
+92 42 35963424
Email
ashfaaqpt@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Danish Ali Khan
Position
Phd Scholar
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
1- Km Raiwind Rd, Sultan Town, Lahore, Punjab
City
Lahore
Province
Punjab
Postal code
54792
Phone
+92 925 813805
Email
dani_ak_pk@hotmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
IPD collected for the primary outcome measure only
When the data will become available and for how long
after the publication of the study
To whom data/document is available
academic institutions and researcher
Under which criteria data/document could be used
on informed request from the investigators
From where data/document is obtainable
via email or telephonic contact with investigator
What processes are involved for a request to access data/document
on email request, data will be provided with in week
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