Protocol summary

Study aim
To determine the effectiveness of Bent Leg Raise approach on Hamstring Flexibility in Patients with Knee Osteoarthritis.
Design
Single Blind, Randomized Controlled Clinical Trial
Settings and conduct
Chaudary Muhammad Akram Research Teaching Hospital (CMARTH) Lahore
Participants/Inclusion and exclusion criteria
The Subjects in ae 40-65 years gender male and female with Osteoarthritis of Grade II and III following Lawrence Kellgren Criteria of Knee OA Radiological classification , with limitation in their Hamstring Range of Motion less than 100-20 Degrees will be included . While Subjects with knee pain, recent injury, trauma in last year and other diagnosed disease like Rheumatoid Arthritis and Patellofemoral syndrome etc. will be excluded
Intervention groups
Group -A In group A Bent Leg Raise with three repetitions as per rule of Brain Mulligan joint Mobilization with Movement concept (MWM) will be given to subjects.
Main outcome variables
Range of Motion , Active Knee Extension Test and KOOS knee Survey

General information

Reason for update
Acronym
Bent Leg Raise Technique
IRCT registration information
IRCT registration number: IRCT20190912044754N2
Registration date: 2021-03-22, 1400/01/02
Registration timing: prospective

Last update: 2021-03-22, 1400/01/02
Update count: 0
Registration date
2021-03-22, 1400/01/02
Registrant information
Name
Tahir Mahmood
Name of organization / entity
Agile Insitute of Rehabilitation Sciences ,Bahawalpur
Country
Pakistan
Phone
+92 62 2888596
Email address
tahirmahmoodphysio@gmail.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2642-06-10, 2021/03/20
Expected recruitment end date
2642-10-17, 2021/07/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Mulligan’s Bent Leg Raise Technique on Hamstring Flexibility in Patients with Knee Osteoarthritis
Public title
Effectiveness of Mulligan’s Bent Leg Raise Technique on Hamstring Flexibility in Patients with Knee Osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The Subjects age 40-65 years , of both gender male and female with Osteoarthritis of Grade II and III following Lawrence Kellgren Criteria of Knee OA Radiological classification , subjects with limitation in their Hamstring Range of Motion less than 100-20 Degrees
Exclusion criteria:
Subjects with knee pain, recent injury, trauma in last year a nd other diagnosed disease like Rheumatoid Arthritis and Patellofemoral syndrome etc.
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization will generated by online Randomizer.
Blinding (investigator's opinion)
Single blinded
Blinding description
The assessor will not have any information about the treatment given in both groups
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Azra Naheed Centre for Research and Development
Street address
Main Raiwind Road
City
Lahore
Postal code
54000
Approval date
2642-05-31, 2021/03/10
Ethics committee reference number
SU/ANCRD/IERC/06

Health conditions studied

1

Description of health condition studied
Osteoarthritis and Hamstring Flexibility
ICD-10 code
S76.312A
ICD-10 code description
Strain of muscle, fascia and tendon of the posterior muscle group at thigh level, left thigh, initial encounter

Primary outcomes

1

Description
Hamstring Flexibility
Timepoint
Baseline , after 2 weeks and 4 weeks
Method of measurement
Active Knee Extension Test

2

Description
Range of Motion
Timepoint
Baseline , after 2 weeks and 4 weeks
Method of measurement
Inclinometer

Secondary outcomes

1

Description
Knee Functioning
Timepoint
Baseline ,2 weeks and after 4 weeks
Method of measurement
KOOS knee Survey

Intervention groups

1

Description
Intervention group A: In group A Bent Leg Raise with three repetitions as per rule of Brain Mulligan joint Mobilization with Movement concept (MWM) will be applied to subjects and 3 session of 10 repetitions with 3 times/week and total of 12 sessions will be given to subjects.
Category
Rehabilitation

2

Description
Control group: Group B treated with Routine Physical Therapy in which Straight Leg Raise stretching method with ,3 session of 10 repetitions ,3 times/week with total of 12 sessions will be given to subjects, along with home plan exercise .
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Azra Naheed Centre for Research and Development
Full name of responsible person
Umer Maqsood
Street address
Main Raiwind Road
City
Lahore
Postal code
54000
Phone
+92 42 38104222
Fax
+92 42 38104222
Email
umer.maqsood@superior.edu.pk
Web page address
http://cmatrh.org.pk/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Chaudhry Muhammad Akram Teaching & Research Hospital
Full name of responsible person
Umer Maqsood
Street address
Raiwind Road Lahore
City
Lahore
Postal code
54000
Phone
+92 42 38020205
Fax
+92 42 38020205
Email
umer.maqsood@superior.edu.pk
Web page address
http://cmatrh.org.pk/
Grant name
NA
Grant code / Reference number
NA
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
NA
Proportion provided by this source
5
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
Agile Insitute of Rehabilitation Sciences ,Bahawalpur
Full name of responsible person
Tahir Mahmood
Position
Senior Lecturer/Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Noor Mahal Road
City
Bahawalpur
Province
Punjab
Postal code
63100
Phone
+92 62 2888596
Fax
+92 62 2888596
Email
tahirmahmoodphysio@gmail.com
Web page address
https://airs.edu.pk/?ic=subcontents&id=1

Person responsible for scientific inquiries

Contact
Name of organization / entity
Umer Maqsood
Full name of responsible person
Azra Naheed Centre for Research and Development
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Main Raiwind Road
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 38020205
Fax
+92 42 38020205
Email
umer.maqsood@superior.edu.pk
Web page address
http://cmatrh.org.pk/

Person responsible for updating data

Contact
Name of organization / entity
Faisal Institute of Heath Sciences
Full name of responsible person
Komal Tariq
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
673/A Peoples Colony No. 1,canal Road Abdullahpur opposite Faisal Hospital Faisalabad,
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 8536999
Fax
+92 41 8536999
Email
komaljutt358@gmail.com
Web page address
http://fihsfsd.edu.pk/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
It will depend upon the journal where it will be published
When the data will become available and for how long
It will depend upon the journal where it will be published
To whom data/document is available
Researchers , scholars, physiotherapist
Under which criteria data/document could be used
None
From where data/document is obtainable
Direct contact with Responsible
What processes are involved for a request to access data/document
Access as per policy
Comments
None
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