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Comparative effects of Daily Adjustable Progressive Resistance Exercises technique and Close kinetic chain exercises on extensor lag in post-operative knee stiffness

Protocol summary

Study aim
To determine the effects of DAPRE technique and close kinetic chain exercises on pain intensity, ROM, function, strength among post-operative knee stiffness.
Design
Randomize clinical trial, not blind trial, 2 group.
Settings and conduct
Pakistan Society of Rehabilitation of Disabled Persons (PSRD).
Participants/Inclusion and exclusion criteria
INCLUSION CRITERIA:• Post-operative knee stiffness (patients with 1-3 month stiffness), Both male and female , age 30-60 years, Willing to participate in research. EXCLUSION CRITERIA:• Pre-operative knee stiffness,Severe cardiopulmpnary disease,Patients undergoing chemotherapy,Any traumatic injury/ Acute inflammatory muscular pathology.
Intervention groups
Group A: DAPRE Technique with conventional therapy. In DAPRE technique, four sets of exercises were performed. The first two sets of exercise consisted of ten and then six repetitions, per- formed against one-half and three-fourths of the previously established working weight. The full working weight was used on the third set, and the patient performed as many repetitions as possible. After performing each of the third and fourth sets, patients rested for 1 min. 6 weeks (3 sessions/week) • Hot pack: 10 min • Stretching of calf and hamstring muscle: 10 min Group B: Close kinetic chain exercises with conventional therapy. Close kinetic chain exercises for extensor lag is seated leg press, double or single one third knee bend, step up and down exercise, wall slide with weight. Treatment time will be 30 minutes and three session per week will be applied on alternate day for up to 6 weeks. Pre interventional readings will be taken at baseline & post interventional readings at 6 weeks • Hot pack: 10 min • Stretching of calf and hamstring muscle: 10 min.
Main outcome variables
Pain(NPRS), KNEE functional improvement(WOMAC), Knee ROM(universal goniometer), Strength.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210108049966N1
Registration date: 2021-02-27, 1399/12/09
Registration timing: retrospective

Last update: 2021-02-27, 1399/12/09
Update count: 0
Registration date
2021-02-27, 1399/12/09
Registrant information
Name
Shanza Tanveer
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 48 3215215
Email address
cheematanvir666@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-20, 1399/07/29
Expected recruitment end date
2020-11-30, 1399/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effects of Daily Adjustable Progressive Resistance Exercises technique and Close kinetic chain exercises on extensor lag in post-operative knee stiffness
Public title
Comparative effects of Daily Adjustable Progressive Resistance Exercises technique and Close kinetic chain exercises on extensor lag in post-operative knee stiffness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Post-operative knee stiffness (patients with 1-3 month stiffness).• Both male and female , age 30-60 years.• Willing to participate in research
Exclusion criteria:
Pre-operative knee stiffness• Severe cardiopulmonary disease• Patients undergoing chemotherapy• Any traumatic injury/ Acute inflammatory muscular pathology• TKR & hip pathology and replacement• Meniscal tear
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 22
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done through sealed envelope method on sample size of 22 individuals selected on inclusion & exclusion criteria in order to minimize biasness. Written informed consent will be taken. Lottary method will be used for allocation. Number of chits will be equal to total sample size, odd numbers for Group A allocation and even numbers for group B allocation.Each patient will be requested to draw a chit from the box.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Riphah International University
Street address
28- M Quaid e Azam Industrial Estate, Kot Lakhpat, Lahore.
City
Lahore
Postal code
54000
Approval date
2020-12-29, 1399/10/09
Ethics committee reference number
RCR/RCR & AHS/20/021

Health conditions studied

1

Description of health condition studied
Stiffness is defined as an inadequate range of motion (ROM) that results in functional limitations in activities of daily living. Although early studies reported stiffness in >50% of patients with TKA. Postoperative stiffness (loss of motion) caused by arthrofibrosis has a deleterious effect on knee function. There is a common belief that the timing of surgery has an effect on the risk of stiffness after anterior cruciate ligament (ACL) reconstruction surgery.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain
Timepoint
Before treatment and after treatment (6th week).
Method of measurement
Numeric pain reading scale (NPRS)

2

Description
Functional performance
Timepoint
Before treatment and after treatment (6th week).
Method of measurement
WOMAC index

3

Description
Knee range of motion
Timepoint
Before treatment and after treatment (6th week).
Method of measurement
Universal goniometer

4

Description
Strength
Timepoint
Before treatment and after treatment (6th week).
Method of measurement
Sphygmomanometer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Group A, 11 participants will receive Conventional physiotherapy treatment in addition to DAPRE technique by leg extension machine. In DAPRE technique, four sets of exercises were performed. The first two sets of exercise consisted of ten and then six repetitions, per- formed against one-half and three-fourths of the previously established working weight. Working weight is the amount of weight a patient uses during an individual session. The full working weight was used on the third set, and the patient performed as many repetitions as possible. After performing each of the third and fourth sets, patients rested for 1 min. 6 weeks (3 sessions per week) • Hot pack: 10 min • Stretching of calf and hamstring muscle: 10 min
Category
Treatment - Other

2

Description
Intervention group: Group B 11 participants will receive Conventional physiotherapy treatment in addition to close kinetic chain exercises. Close kinetic chain exercises for extensor lag is seated leg press, double or single one third knee bend, step up and down exercise, wall slide with weight. Treatment time will be 30 minutes and three session per week will be applied on alternate day for up to 6 weeks. Pre interventional readings will be taken at baseline & post interventional readings at 6th week. 6 weeks (3 sessions per week) • Hot pack: 10 min • Stretching of calf and hamstring muscle: 10 min.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Pakistan Society for the Rehabilitation of the Disabled
Full name of responsible person
Shanza Tanveer
Street address
House no.1 block A muhafiz town, Sargodha
City
Sargodha
Postal code
40100
Phone
+92 48 3215215
Fax
Email
cheematanvir666@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Pakistan Society for the Rehabilitation of the Disabled, Lahore.
Full name of responsible person
Shanza Tanveer
Street address
House no.1 block A muhafiz town,, Sargodha.
City
Sargodha
Postal code
40100
Phone
+92 48 3215215
Email
cheematanvir666@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Pakistan Society for the Rehabilitation of the Disabled,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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Riphah International University Lahore, Pakistan
Full name of responsible person
Shanza Tanveer
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
House no.1 block A muhafiz town, Sargodha.
City
Sargodha
Province
Punjab
Postal code
40100
Phone
+92 48 3215215
Fax
Email
cheematanvir666@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Riphah College of Rehabilitation Sciences (RCRS)
Full name of responsible person
Shanza Tanveer
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
House no.1 block A muhafiz town, Sargodha.
City
Sargodha
Province
Punjab
Postal code
40100
Phone
+92 48 3215215
Fax
Email
cheematanvir666@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Riphah College of Rehabilitation Sciences (RCRS)
Full name of responsible person
Shanza Tanveer
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
House no.1 block A muhafiz town, Sargodha.
City
Sargodha
Province
Punjab
Postal code
40100
Phone
+92 48 3215215
Fax
Email
cheematanvir666@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further decision & information is decided yet.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
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